Depression and Pain Perseverance Through Empowered Recovery Intervention (DAPPER)
Primary Purpose
Pain, Depressive Symptoms, Frailty
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DAPPER
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring African American, Women's Health
Eligibility Criteria
Inclusion Criteria:
- Self-report pain >3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do
- Self-Identify as African American/Black female
- Live in a community dwelling
- Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)
- Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
- One ADL or IADL limitation
Exclusion Criteria:
- Hospitalized > 3 times in the last year
- Participating in physical therapy
- Have a terminal diagnosis (<1 year expected survival)
- > moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)
- Unable to speak or understand English
Sites / Locations
- Johns Hopkins School of NursingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Arm
Wait List Control Arm
Arm Description
The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time.
Once the intervention group has completed the intervention the wait list control group will complete the intervention.
Outcomes
Primary Outcome Measures
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Change in Pain Interference as assessed by the PROMIS Pain Interference
The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference is a six item scale used to measure how much pain interferes with activities. The scores can range from 6-30. Higher scores indicate more pain interference with activities.
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms.
Change in Depressive Symptoms as assessed by the PROMIS 57
The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms.
Secondary Outcome Measures
Change in Frailty as assessed by the Frailty Phenotype measure
The Frailty Phenotype measure is used to determine if a person is robust (score of 0), pre-frail (score of 1 or 2), or frail (score of 3-5).
Change in Frailty as assessed by the Frail Scale
The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty.
Change in Physical Function as assessed by the Katz Activities of daily living (ADL)
The Katz Activities of daily living (ADL) is used measure physical function through ability to perform activities of daily living. Score ranges are from 0-6 with 6 indicating full function and a score of 2 or less indicating severe functional impairment.
Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)
Lawton's Instrumental Activities of Daily Living (IADL) measures instrumental activities of daily living as a measure of physical function. The scores range from 0-8 with higher scores indicating better physical function.
Full Information
NCT ID
NCT04091347
First Posted
September 13, 2019
Last Updated
September 27, 2023
Sponsor
Johns Hopkins University
Collaborators
Robert Wood Johnson Foundation, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04091347
Brief Title
Depression and Pain Perseverance Through Empowered Recovery Intervention
Acronym
DAPPER
Official Title
Pilot Study of Depression and Pain Perseverance Through Empowered Recovery (DAPPER) Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Robert Wood Johnson Foundation, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
African American women who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the DAPPER intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.
Detailed Description
The proposed intervention is called Depression and Pain Perseverance through Empowered Recovery (DAPPER). The investigators are adapting the Get Busy Get Better intervention by adding components (e.g. nurse visits and person directed goals) from the CAPABLE study for this intervention. The investigator will further develop the intervention through this two-phase pilot test. The aims of this pilot project are to 1) test the Depression and Pain Perseverance through Empowered Recovery (DAPPER) program for feasibility and acceptability. Specifically, the investigators will test the effect size of DAPPER on pain and depressive symptoms from baseline to 12 weeks (compare intervention to wait list control group) and then at 24 weeks to compare the intervention group to wait list control group once again. 2) estimate preliminary effect sizes for DAPPER in reduction pain and depressive symptoms, 3) measure effect sizes and feasibility of measuring cytokines and heart rate variability (HRV).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Depressive Symptoms, Frailty, Aging
Keywords
African American, Women's Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigator will conduct subsequent single blind wait list control design to test the preliminary effects of DAPPER and the feasibility of older African American women integrating strategies to address pain, depression, and frailty that are tailored to the individual into the individual's daily routines.
Masking
InvestigatorOutcomes Assessor
Masking Description
The statistician will be responsible for randomization and the investigator and study team will not have knowledge if participants are assigned to intervention group or wait list control group.
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time.
Arm Title
Wait List Control Arm
Arm Type
Active Comparator
Arm Description
Once the intervention group has completed the intervention the wait list control group will complete the intervention.
Intervention Type
Behavioral
Intervention Name(s)
DAPPER
Intervention Description
The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks.
Primary Outcome Measure Information:
Title
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
Description
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Pain Interference as assessed by the PROMIS Pain Interference
Description
The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference is a six item scale used to measure how much pain interferes with activities. The scores can range from 6-30. Higher scores indicate more pain interference with activities.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)
Description
The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Depressive Symptoms as assessed by the PROMIS 57
Description
The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms.
Time Frame
Baseline, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Change in Frailty as assessed by the Frailty Phenotype measure
Description
The Frailty Phenotype measure is used to determine if a person is robust (score of 0), pre-frail (score of 1 or 2), or frail (score of 3-5).
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Frailty as assessed by the Frail Scale
Description
The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Physical Function as assessed by the Katz Activities of daily living (ADL)
Description
The Katz Activities of daily living (ADL) is used measure physical function through ability to perform activities of daily living. Score ranges are from 0-6 with 6 indicating full function and a score of 2 or less indicating severe functional impairment.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)
Description
Lawton's Instrumental Activities of Daily Living (IADL) measures instrumental activities of daily living as a measure of physical function. The scores range from 0-8 with higher scores indicating better physical function.
Time Frame
Baseline, 12 weeks and 24 weeks
Other Pre-specified Outcome Measures:
Title
Change in Communication with Health Care Providers as assessed by the Patients' Reaction Assessment
Description
The Patients' Reaction Assessment has a 5-item subscale used to measure perceived ability to communicate with providers. The sub scale on perceived ability to communicate with providers can have scores ranging from 0-35 with higher scores indicating higher perceived ability to communicate.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Stress as assessed by the Perceived Stress Scale
Description
The Perceived Stress Scale assesses a person's perceived stress levels. The scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Social engagement as assessed by the Social Network Scale
Description
The Lubben Social Network Scale -6 is used to measure social engagement including family and friends. The scores range from 0 to 60 with higher scores indicating more social engagement.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Self Efficacy as assessed by the Coping and Self-Efficacy Scale
Description
The Coping and Self-Efficacy Scale is a 26 item scale used to measure coping and self efficacy. The scores on this instrument range from 0-260 with higher scores indicating more self efficacy.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Comorbid Conditions as assessed by the Charlson Comorbidity Index
Description
The Charlson Comorbidity Index consists of 17 categories of chronic conditions and two subcategories for diabetes and liver disease. The severity of diseases are determined by a score of 1-6. A total comorbidity index score is complied and higher scores indicate more chronic conditions and higher risk of mortality.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in interleukin (IL)-6 in saliva (pg/ml)
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in interleukin (IL)-8 in saliva (pg/ml)
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in interleukin (IL)-1 beta in saliva (pg/ml)
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in tumor necrosis factor (TNF)-alpha in saliva (pg/ml)
Time Frame
Baseline, 12 weeks and 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self-report pain >3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do
Self-Identify as African American/Black female
Live in a community dwelling
Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)
Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
One ADL or IADL limitation
Exclusion Criteria:
Hospitalized > 3 times in the last year
Participating in physical therapy
Have a terminal diagnosis (<1 year expected survival)
> moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)
Unable to speak or understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janiece Taylor, PhD
Phone
443-287-4503
Email
jwalke90@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Szanton, PhD
Phone
410-502-2605
Email
sarah.szanton@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janiece L Taylor, PhD
Organizational Affiliation
Johns Hopkins School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janiece Taylor, PhD
Phone
443-287-4503
Email
jwalke90@jhu.edu
First Name & Middle Initial & Last Name & Degree
Sarah Szanton, PhD
Phone
(410) 502-2605 s
Email
sszanto1@jhu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Depression and Pain Perseverance Through Empowered Recovery Intervention
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