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Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors (AFTER)

Primary Purpose

Covid-19, Deconditioning

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biobehavioral Tele-rehabilitation Sessions
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Tele-rehabilitation, High Intensity, Biobehavioral, Activity Self-Monitoring, Physical Functional Performance

Eligibility Criteria

35 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Confirmed COVID-19, per diagnostic criteria (PCR testing)
  2. Hospitalized for at least 24 hours
  3. Able to provide informed consent
  4. Internet capability to access the platform
  5. Community-dwelling prior to hospitalization

Exclusion Criteria:

  1. Unstable medical comorbidities that would preclude participation in exercise
  2. Receipt of >1 session of outpatient physical therapy
  3. Known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of COVID-19
  4. Anticipating concurrent additional physical therapy services during study intervention period (12 weeks)

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

This group will receive 12 biobehaviorally informed tele-rehabilitation sessions including high-intensity strengthening; sessions will be delivered by a licensed physical therapist. An application ('Platform') will facilitate home exercise program completion outside of the supervised sessions. Other: remote controlled exercise plus home exercise Treatments: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise

This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training. Other: basic education

Outcomes

Primary Outcome Measures

Adherence (Primary Feasibility/Safety Outcome)
Feasibility will be measured by program adherence, defined as the number of sessions attended divided by the total number of prescribed sessions (n=12). Individuals will be considered adherent if they attend at least 75% (n=9) of the total sessions. Adherence will be collected in the intervention group only.
Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. To facilitate accuracy of the test over video, the participant will be instructed to count out loud each time he/she stands. Further, the test will also be facilitated by the Platform.

Secondary Outcome Measures

System Usability Scale (SUS)
The SUS is a 10-item survey that uses a 5-point Likert scale (Strongly disagree (1) to Strongly agree (5)). Scores range from 0 to 100 and higher scores indicate better usability. The SUS will be collected in the intervention group only.
Safety Event Count
The Safety Event Count is the cumulative number of participants who experienced adverse events and severe adverse events counted from baseline to week 12. Events will be categorized by type.
Timed Up-and-Go Test (TUG)
The TUG test measures the time it takes for a person to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Participants will complete the TUG test twice and the best time will be used. Faster times indicate better physical function and lower risk of falls.
4-Stage Balance Test
The 4-stage balance test measures static balance in 4 different positions (narrow base of support, semi-tandem, tandem, and single-leg). The test is facilitated by the Platform; it requires participants to hold each position for up to 10 seconds. If a participant is unable to hold a position for 10 seconds, the next hardest position is not performed. Completing higher levels indicate lesser fall risk and better balance. Total scores range from 0 to 40, with higher scores indicating better outcomes.
MRC Dyspnea
The MRC dyspnea scale is an interviewer-administered or self-report assessment of the perception of difficulty breathing during five different tasks. Participants respond either yes or no to each task. Score is the sum of the number of Yes answers, 0-5. Higher numbers indicate more difficulty breathing
Activities-Specific Balance Confidence (ABC) Scale
The ABC Scale is a 16-item self-report measure of balance confidence in performing activities without losing balance or experiencing a sense of unsteadiness. Score range: 0-100. Higher scores indicate higher confidence in performing activities without losing balance.
Three-Item Loneliness Scale
This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness.
PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a
The PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a consists of 4 items rated on a 5-point Likert scale (not at all confident (1) to very confident (5)); values range from 4-20. Higher scores indicate higher levels of general self-efficacy.
PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions
The PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions is an 8-item scale rated on a 5-point Likert scale;values range from 8-32. Higher scores indicate higher levels of self confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations.
PROMIS Scale v1.2 Global Health:
The PROMIS Scale v1.2 Global Health measures quality of life on two domains: physical and mental health. Raw values for each domain range from 4 - 20; scores are converted to a t-score with a mean of 50 and SD of 10. Higher scores indicate better health.
Montreal Cognitive Assessment (MoCA)-BLIND
The MoCA-BLIND assesses different cognitive domains: attention, concentration, memory, language, conceptual thinking, calculations, and orientation. The MoCA-BLIND has removed assessments requiring vision, thus can be completed using telehealth or telephone assessments. Score range: 0-22, with 18-22 normal range.
Clinical Frailty Scale
The Clinical Frailty scale is a self-report scale to estimate function. The participant selects perceived level of function prior to and following admission ranging from very active to bedridden/terminal. Score range: 1 (very fit) - 9 (terminally ill), with higher scores indicating higher levels of frailty.
Average Daily Step Count
Average Daily Step Count per week will be collected via a Fitbit activity monitor. Higher step counts indicate higher level of physical activity.
Patient Health Questionnaire 8 (PHQ8)
The Patient Health Questionnaire 8 measures severity of depressive symptoms over the past 2 weeks. The 8 item scale is rated on a 4 point scale (not at all to nearly every day). Score range: 0-24. Higher scores indicate more severe depressive symptoms.

Full Information

First Posted
December 8, 2020
Last Updated
October 10, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04663945
Brief Title
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
Acronym
AFTER
Official Title
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
August 12, 2021 (Actual)
Study Completion Date
December 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized due to COVID-19.
Detailed Description
The aim of this study is to investigate the feasibility and initial efficacy of a multicomponent tele-rehabilitation program during COVID-19 recovery. The tele-rehabilitation program will include biobehavioral training and high intensity exercise facilitated through an online application ('Platform'). Initial efficacy will be assessed primarily by performance on the 30" Chair Stand Test and secondarily through other physical function tests and patient reported outcome measures. This study will advance the feasibility of tele-rehabilitation as a more generally useful intervention in patients lacking access (distance, availability, mobility) to standard rehabilitative services and could transform the way in which acute rehabilitation and post-hospital care is delivered for all patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Deconditioning
Keywords
Tele-rehabilitation, High Intensity, Biobehavioral, Activity Self-Monitoring, Physical Functional Performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group will receive 12 biobehaviorally informed tele-rehabilitation sessions including high-intensity strengthening; sessions will be delivered by a licensed physical therapist. An application ('Platform') will facilitate home exercise program completion outside of the supervised sessions. Other: remote controlled exercise plus home exercise Treatments: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training. Other: basic education
Intervention Type
Behavioral
Intervention Name(s)
Biobehavioral Tele-rehabilitation Sessions
Intervention Description
Biobehavioral tele-rehabilitation sessions
Primary Outcome Measure Information:
Title
Adherence (Primary Feasibility/Safety Outcome)
Description
Feasibility will be measured by program adherence, defined as the number of sessions attended divided by the total number of prescribed sessions (n=12). Individuals will be considered adherent if they attend at least 75% (n=9) of the total sessions. Adherence will be collected in the intervention group only.
Time Frame
12 weeks
Title
Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
Description
The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. To facilitate accuracy of the test over video, the participant will be instructed to count out loud each time he/she stands. Further, the test will also be facilitated by the Platform.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary Outcome Measure Information:
Title
System Usability Scale (SUS)
Description
The SUS is a 10-item survey that uses a 5-point Likert scale (Strongly disagree (1) to Strongly agree (5)). Scores range from 0 to 100 and higher scores indicate better usability. The SUS will be collected in the intervention group only.
Time Frame
6 weeks (primary end point)
Title
Safety Event Count
Description
The Safety Event Count is the cumulative number of participants who experienced adverse events and severe adverse events counted from baseline to week 12. Events will be categorized by type.
Time Frame
Week 12
Title
Timed Up-and-Go Test (TUG)
Description
The TUG test measures the time it takes for a person to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Participants will complete the TUG test twice and the best time will be used. Faster times indicate better physical function and lower risk of falls.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
4-Stage Balance Test
Description
The 4-stage balance test measures static balance in 4 different positions (narrow base of support, semi-tandem, tandem, and single-leg). The test is facilitated by the Platform; it requires participants to hold each position for up to 10 seconds. If a participant is unable to hold a position for 10 seconds, the next hardest position is not performed. Completing higher levels indicate lesser fall risk and better balance. Total scores range from 0 to 40, with higher scores indicating better outcomes.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
MRC Dyspnea
Description
The MRC dyspnea scale is an interviewer-administered or self-report assessment of the perception of difficulty breathing during five different tasks. Participants respond either yes or no to each task. Score is the sum of the number of Yes answers, 0-5. Higher numbers indicate more difficulty breathing
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
Activities-Specific Balance Confidence (ABC) Scale
Description
The ABC Scale is a 16-item self-report measure of balance confidence in performing activities without losing balance or experiencing a sense of unsteadiness. Score range: 0-100. Higher scores indicate higher confidence in performing activities without losing balance.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
Three-Item Loneliness Scale
Description
This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a
Description
The PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a consists of 4 items rated on a 5-point Likert scale (not at all confident (1) to very confident (5)); values range from 4-20. Higher scores indicate higher levels of general self-efficacy.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions
Description
The PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions is an 8-item scale rated on a 5-point Likert scale;values range from 8-32. Higher scores indicate higher levels of self confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
PROMIS Scale v1.2 Global Health:
Description
The PROMIS Scale v1.2 Global Health measures quality of life on two domains: physical and mental health. Raw values for each domain range from 4 - 20; scores are converted to a t-score with a mean of 50 and SD of 10. Higher scores indicate better health.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
Montreal Cognitive Assessment (MoCA)-BLIND
Description
The MoCA-BLIND assesses different cognitive domains: attention, concentration, memory, language, conceptual thinking, calculations, and orientation. The MoCA-BLIND has removed assessments requiring vision, thus can be completed using telehealth or telephone assessments. Score range: 0-22, with 18-22 normal range.
Time Frame
Change from Baseline to week 12
Title
Clinical Frailty Scale
Description
The Clinical Frailty scale is a self-report scale to estimate function. The participant selects perceived level of function prior to and following admission ranging from very active to bedridden/terminal. Score range: 1 (very fit) - 9 (terminally ill), with higher scores indicating higher levels of frailty.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
Average Daily Step Count
Description
Average Daily Step Count per week will be collected via a Fitbit activity monitor. Higher step counts indicate higher level of physical activity.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Title
Patient Health Questionnaire 8 (PHQ8)
Description
The Patient Health Questionnaire 8 measures severity of depressive symptoms over the past 2 weeks. The 8 item scale is rated on a 4 point scale (not at all to nearly every day). Score range: 0-24. Higher scores indicate more severe depressive symptoms.
Time Frame
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed COVID-19, per diagnostic criteria (PCR testing) Hospitalized for at least 24 hours Able to provide informed consent Internet capability to access the platform Community-dwelling prior to hospitalization Exclusion Criteria: Unstable medical comorbidities that would preclude participation in exercise Receipt of >1 session of outpatient physical therapy Known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of COVID-19 Anticipating concurrent additional physical therapy services during study intervention period (12 weeks)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Erlandson, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon written request of the study team and an established data use agreement (DUA) between the University of Colorado Anschutz Medical Campus (UCD-AMC) and the requestor's institution, we will provide a deidentified dataset including a data dictionary. Deidentification of the datasets will be conducted with respect to HIPAA definitions, with add back of variables that express all dates as number of days since a milestone event, enrollment, and a variable storing just the year. For example, the milestone event would be "Day 0" in this case.
IPD Sharing Time Frame
The main study results will be posted in ClinicalTrials.gov and will remain there indefinitely. All other study documents and data will be made available within a reasonable time frame following a valid written request.
IPD Sharing Access Criteria
Other related study documents will be made available upon reasonable written request
Citations:
PubMed Identifier
35882451
Citation
Capin JJ, Jolley SE, Morrow M, Connors M, Hare K, MaWhinney S, Nordon-Craft A, Rauzi M, Flynn S, Stevens-Lapsley JE, Erlandson KM. Safety, feasibility and initial efficacy of an app-facilitated telerehabilitation (AFTER) programme for COVID-19 survivors: a pilot randomised study. BMJ Open. 2022 Jul 26;12(7):e061285. doi: 10.1136/bmjopen-2022-061285.
Results Reference
derived

Learn more about this trial

Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors

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