Depression and Pain Perseverance Through Empowered Recovery Intervention (DAPPER)

Pilot Study of Depression and Pain Perseverance Through Empowered Recovery (DAPPER) Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Frailty; Aging; Depressive Symptoms
• Intervention / Treatment: Behavioral: DAPPER

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).

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janiece Taylor, PhD; Phone Number: 443-287-4503; Email: jwalke90@jhu.edu
• Study Contact Backup: Name: Sarah Szanton, PhD; Phone Number: 410-502-2605; Email: sarah.szanton@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins School of Nursing
      • Contact: Janiece Taylor, PhD; Phone Number: 443-287-4503; Email: jwalke90@jhu.edu
      • Contact: Sarah Szanton, PhD; Phone Number: (410) 502-2605 s; Email: sszanto1@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	Behavioral: DAPPER; 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.
Active Comparator: Wait List Control Arm; Once the intervention group has completed the intervention the wait list control group will complete the intervention.	Behavioral: DAPPER; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 weeks and 24 weeks
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.	Baseline, 12 weeks and 24 weeks
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.	Baseline, 12 weeks and 24 weeks
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.	Baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 12 weeks and 24 weeks
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.	Baseline, 12 weeks and 24 weeks
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.	Baseline, 12 weeks and 24 weeks
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.	Baseline, 12 weeks and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Communication with Health Care Providers as assessed by the Patients' Reaction Assessment	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.	Baseline, 12 weeks and 24 weeks
Change in Stress as assessed by the Perceived Stress Scale	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.	Baseline, 12 weeks and 24 weeks
Change in Social engagement as assessed by the Social Network Scale	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.	Baseline, 12 weeks and 24 weeks
Change in Self Efficacy as assessed by the Coping and Self-Efficacy Scale	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.	Baseline, 12 weeks and 24 weeks
Change in Comorbid Conditions as assessed by the Charlson Comorbidity Index	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.	Baseline, 12 weeks and 24 weeks
Change in interleukin (IL)-6 in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks
Change in interleukin (IL)-8 in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks
Change in interleukin (IL)-1 beta in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks
Change in tumor necrosis factor (TNF)-alpha in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA); Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Janiece L Taylor, PhD, Johns Hopkins School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: African American; Women's Health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Depression; Frailty
• Other Study ID Numbers: IRB00226182; P30AG021334 (U.S. NIH Grant/Contract); 75206 (Other Grant/Funding Number: Robert Wood Johnson Harold Amos Medical Faculty Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No