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Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation (HH)

Primary Purpose

Insomnia, Pain, Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Habits
Sleep Habits
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Knee Arthroplasty, Hip Arthroplasty, Rehabilitation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients (ages 55+) planning on having a hip or knee arthroplasty.
  2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).
  3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.
  4. Score ≥10 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
  5. Referral and attendance of medical rehabilitation post-discharge.

Exclusion Criteria:

  1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
  2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded).
  3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
  4. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.
  5. Must live within 30 miles of recruiting site.

Sites / Locations

  • University of Texas Medical BranchRecruiting
  • Baylor College of Medicine Medical CenterRecruiting
  • Kelsey Seybold ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy Habits

Sleep Habits

Arm Description

This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.

This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Insomnia Severity Index (ISI)
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Insomnia Severity Index (ISI)
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Insomnia Severity Index (ISI)
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Wrist actigraphy
A wearable device will be used to measure participant sleep over seven days.
Wrist actigraphy
A wearable device will be used to measure participant sleep over seven days.
Wrist actigraphy
A wearable device will be used to measure participant sleep over seven days.
Wrist actigraphy
A wearable device will be used to measure participant sleep over seven days.

Secondary Outcome Measures

PROMIS Physical Function (short form)
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
PROMIS Physical Function (short form)
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
PROMIS Physical Function (short form)
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
PROMIS Physical Function (short form)
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
PROMIS Mobility
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
PROMIS Mobility
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
PROMIS Mobility
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
PROMIS Mobility
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
Short Physical Performance Battery (SPPB ) motor
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Short Physical Performance Battery (SPPB ) motor
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Short Physical Performance Battery (SPPB ) motor
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Short Physical Performance Battery (SPPB ) motor
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
PROMIS Applied Cognitive Abilities
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
PROMIS Applied Cognitive Abilities
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
PROMIS Applied Cognitive Abilities
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
PROMIS Applied Cognitive Abilities
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
PROMIS Applied Cognitive Abilities- General Concerns
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
PROMIS Applied Cognitive Abilities- General Concerns
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
PROMIS Applied Cognitive Abilities- General Concerns
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
PROMIS Applied Cognitive Abilities - General Concerns
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
Tele-neuropsychology (T-NP) Battery
The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall) Cognition tests will be scored.
Tele-neuropsychology (T-NP) Battery
The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.
Tele-neuropsychology (T-NP) Battery
The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.
Tele-neuropsychology (T-NP) Battery
The TNP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.
Activities of Daily Living (ADLs)
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Activities of Daily Living (ADLs)
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Activities of Daily Living (ADLs)
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Activities of Daily Living (ADLs)
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Instrumental ADLs (IADL) scale
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Instrumental ADLs (IADL) scale
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Instrumental ADLs (IADL) scale
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Instrumental ADLs (IADL) scale
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Sleep Diary
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Sleep Diary
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Sleep Diary
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Sleep Diary
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Sleep Diary
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Knee injury and osteoarthritis outcome score (KOOS)
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
Knee injury and osteoarthritis outcome score (KOOS)
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
Hip disability and osteoarthritis outcome score (HOOS)
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
Hip disability and osteoarthritis outcome score (HOOS)
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
StepWatch
A wearable device will measure physical activity over a seven day period.
StepWatch
A wearable device will measure physical activity over a seven day period.
StepWatch
A wearable device will measure physical activity over a seven day period.
StepWatch
A wearable device will measure physical activity over a seven day period.

Full Information

First Posted
February 10, 2020
Last Updated
August 22, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04269239
Brief Title
Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Acronym
HH
Official Title
Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.
Detailed Description
Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
Keywords
Knee Arthroplasty, Hip Arthroplasty, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either the a healthy habits group or a sleep habits group.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Habits
Arm Type
Other
Arm Description
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
Arm Title
Sleep Habits
Arm Type
Other
Arm Description
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Habits
Intervention Description
Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Habits
Intervention Description
Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Time Frame
7-14 days before scheduled surgery
Title
Insomnia Severity Index (ISI)
Description
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Time Frame
7-14 days after hospital discharge
Title
Insomnia Severity Index (ISI)
Description
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Time Frame
7-14 days after completing the 8 week intervention period
Title
Insomnia Severity Index (ISI)
Description
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Time Frame
6 months after completing the intervention
Title
Wrist actigraphy
Description
A wearable device will be used to measure participant sleep over seven days.
Time Frame
7-14 days before scheduled surgery
Title
Wrist actigraphy
Description
A wearable device will be used to measure participant sleep over seven days.
Time Frame
7-14 days after hospital discharge
Title
Wrist actigraphy
Description
A wearable device will be used to measure participant sleep over seven days.
Time Frame
7-14 days after completing the 8 week intervention period
Title
Wrist actigraphy
Description
A wearable device will be used to measure participant sleep over seven days.
Time Frame
6 months after completing the intervention
Secondary Outcome Measure Information:
Title
PROMIS Physical Function (short form)
Description
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Physical Function (short form)
Description
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
Time Frame
7-14 days after hospital discharge
Title
PROMIS Physical Function (short form)
Description
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Physical Function (short form)
Description
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'
Time Frame
6 months after completing the intervention
Title
PROMIS Mobility
Description
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Mobility
Description
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Mobility
Description
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Mobility
Description
The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.
Time Frame
6 months after completing the intervention
Title
Short Physical Performance Battery (SPPB ) motor
Description
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Time Frame
7-14 days before scheduled surgery
Title
Short Physical Performance Battery (SPPB ) motor
Description
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Time Frame
7-14 days after hospital discharge
Title
Short Physical Performance Battery (SPPB ) motor
Description
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Time Frame
7-14 days after completing the 8 week intervention period
Title
Short Physical Performance Battery (SPPB ) motor
Description
The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Time Frame
6 months after completing the intervention
Title
PROMIS Applied Cognitive Abilities
Description
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Applied Cognitive Abilities
Description
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Applied Cognitive Abilities
Description
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Applied Cognitive Abilities
Description
The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.
Time Frame
6 months after completing the intervention
Title
PROMIS Applied Cognitive Abilities- General Concerns
Description
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Applied Cognitive Abilities- General Concerns
Description
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Applied Cognitive Abilities- General Concerns
Description
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Applied Cognitive Abilities - General Concerns
Description
The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.
Time Frame
6 months after completing the intervention
Title
Tele-neuropsychology (T-NP) Battery
Description
The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall) Cognition tests will be scored.
Time Frame
7-14 days before scheduled surgery
Title
Tele-neuropsychology (T-NP) Battery
Description
The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.
Time Frame
7-14 days after hospital discharge
Title
Tele-neuropsychology (T-NP) Battery
Description
The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.
Time Frame
7-14 days after completing the 8 week intervention period
Title
Tele-neuropsychology (T-NP) Battery
Description
The TNP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.
Time Frame
6 months after completing the intervention
Title
Activities of Daily Living (ADLs)
Description
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Time Frame
7-14 days before scheduled surgery
Title
Activities of Daily Living (ADLs)
Description
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Time Frame
7-14 days after hospital discharge
Title
Activities of Daily Living (ADLs)
Description
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Time Frame
7-14 days after completing the 8 week intervention period
Title
Activities of Daily Living (ADLs)
Description
The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"
Time Frame
6 months after completing the intervention
Title
Instrumental ADLs (IADL) scale
Description
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Time Frame
7-14 days before scheduled surgery
Title
Instrumental ADLs (IADL) scale
Description
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Time Frame
7-14 days after hospital discharge
Title
Instrumental ADLs (IADL) scale
Description
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Time Frame
7-14 days after completing the 8 week intervention period and
Title
Instrumental ADLs (IADL) scale
Description
The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.
Time Frame
6 months after completing the intervention
Title
Sleep Diary
Description
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Time Frame
7-14 days before scheduled surgery
Title
Sleep Diary
Description
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Time Frame
7-14 days after hospital discharge
Title
Sleep Diary
Description
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Time Frame
During the 8 week intervention
Title
Sleep Diary
Description
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Time Frame
7-14 days after completing the 8 week intervention period
Title
Sleep Diary
Description
The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
Time Frame
6 months after completing the intervention
Title
Knee injury and osteoarthritis outcome score (KOOS)
Description
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
Time Frame
7-14 days before scheduled surgery
Title
Knee injury and osteoarthritis outcome score (KOOS)
Description
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
Time Frame
6 months after completing intervention
Title
Hip disability and osteoarthritis outcome score (HOOS)
Description
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
Time Frame
7-14 days before scheduled surgery
Title
Hip disability and osteoarthritis outcome score (HOOS)
Description
This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
Time Frame
6 months after completing intervention
Title
StepWatch
Description
A wearable device will measure physical activity over a seven day period.
Time Frame
7-14 days before scheduled surgery
Title
StepWatch
Description
A wearable device will measure physical activity over a seven day period.
Time Frame
7-14 days after hospital discharge
Title
StepWatch
Description
A wearable device will measure physical activity over a seven day period.
Time Frame
7-14 days after completing the 8 week intervention period
Title
StepWatch
Description
A wearable device will measure physical activity over a seven day period.
Time Frame
6 months after completing the intervention
Other Pre-specified Outcome Measures:
Title
PROMIS Pain Intensity
Description
The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Pain Intensity
Description
The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Pain Intensity
Description
The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Pain Intensity
Description
The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Time Frame
6 months after completing the intervention
Title
PROMIS Pain Interference
Description
The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days before schedule surgery
Title
PROMIS Pain Interference
Description
The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Pain Interference
Description
The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Pain Interference
Description
The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Time Frame
6 months after completing the intervention
Title
PROMIS Fatigue
Description
The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Fatigue
Description
The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Fatigue
Description
The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Fatigue
Description
The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Time Frame
6 months after completing the intervention
Title
PROMIS Emotional Distress-Depressesion
Description
The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Emotional Distress-Depressesion
Description
The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Emotional Distress-Depressesion
Description
The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Emotional Distress-Depressesion
Description
The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Time Frame
6 months after completing the intervention
Title
PROMIS Psychosocial Illness Impact - Negative
Description
The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Psychosocial Illness Impact - Negative
Description
The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Psychosocial Illness Impact - Negative
Description
The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Psychosocial Illness Impact - Negative
Description
The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
6 months after completing the intervention
Title
PROMIS Satisfaction with Social Roles and Activities
Description
The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Satisfaction with Social Roles and Activities
Description
The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Satisfaction with Social Roles and Activities
Description
The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Satisfaction with Social Roles and Activities
Description
The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
6 months after completing the intervention
Title
PROMIS Ability to Participate in Social Roles and Activity
Description
The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days before scheduled surgery
Title
PROMIS Ability to Participate in Social Roles and Activity
Description
The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after hospital discharge
Title
PROMIS Ability to Participate in Social Roles and Activity
Description
The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
7-14 days after completing the 8 week intervention period
Title
PROMIS Ability to Participate in Social Roles and Activity
Description
The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Time Frame
6 months after completing the intervention
Title
Rehabilitation Attendance
Description
Weekly rehabilitation attendance will be measured via patient self-report.
Time Frame
From hospital discharge until subject notifies study staff they have stopped attending, on average around 12 weeks.
Title
Plasma IL-6
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).
Time Frame
7-14 days before scheduled surgery
Title
Plasma IL-6
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).
Time Frame
7-14 days after hospital discharge
Title
Plasma IL-6
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).
Time Frame
7-14 days after completing the 8 week intervention period
Title
Plasma IL-6
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).
Time Frame
6 months after completing the intervention
Title
Plasma CRP
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Time Frame
7-14 days before scheduled surgery
Title
Plasma CRP
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Time Frame
7-14 days after hospital discharge
Title
Plasma CRP
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Time Frame
7-14 days after completing the 8 week intervention period
Title
Plasma CRP
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Time Frame
6 months after completing the intervention
Title
Plasma VWF
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Time Frame
7-14 days before scheduled surgery
Title
Plasma VWF
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Time Frame
7-14 days after hospital discharge
Title
Plasma VWF
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Time Frame
7-14 days after completing the 8 week intervention period
Title
Plasma VWF
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Time Frame
6 months after completing the intervention
Title
Plasma TNFalpha
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Time Frame
7-14 days before scheduled surgery
Title
Plasma TNFalpha
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Time Frame
7-14 days after hospital discharge
Title
Plasma TNFalpha
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Time Frame
7-14 days after completing the 8 week intervention period
Title
Plasma TNFalpha
Description
Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Time Frame
6 months after completing the intervention
Title
Medication Monitoring Form
Description
Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Time Frame
7-14 days before schedule surgery
Title
Medication Monitoring Form
Description
Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Time Frame
7-14 days after hospital discharge
Title
Medication Monitoring Form
Description
Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Time Frame
7-14 days after completing the 8 week intervention period
Title
Medication Monitoring Form
Description
Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Time Frame
6 months after completing the intervention
Title
Treatment Expectation Questionnaire
Description
This questionnaire 8-question measure provided before treatment. It will be used to collect information on participants' reasons for treatment as well as their expectations of treatment (e.g., its effectiveness, the amount of effort it will take, confidence in their doctor). Participant will mark answers to each question on a visual analog scale (e.g., from Not Confident at all to Very Confident).
Time Frame
Immediately prior to beginning the intervention
Title
Treatment Satisfaction Questionnaire
Description
Treatment Satisfaction Scale is a 10-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much.
Time Frame
Immediately following the completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment). Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI). Referral and attendance of medical rehabilitation post-discharge. Exclusion Criteria: Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year). Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded). Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doris Escobedo
Phone
713-487-5540
Email
doris.escobedo@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Lantz, PhD
Email
ejlantz@utmb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Nowakowski, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Lantz, PhD
Phone
409-772-0643
Email
ejlantz@utmb.edu
Facility Name
Baylor College of Medicine Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris Escobedo
Phone
713-487-5540
Email
doris.escobedo@bcm.edu
Facility Name
Kelsey Seybold Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edina Dervisefendic
Email
edina.dervisefendic@kelseyresearch.com
First Name & Middle Initial & Last Name & Degree
Ashley Alexander
Phone
713-442-1222
Email
Ashley.Alexander@KelseyResearch.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

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