Depression and Pain Perseverance Through Empowered Recovery Intervention

Pain Clinical Trial

— DAPPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091347
• Other study ID #: IRB00226182
• Secondary ID: 75206P30AG021334
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Janiece Taylor, PhD
• Phone: 443-287-4503
• Email: jwalke90[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Depression
• Depressive Symptoms
• Frailty
• Pain

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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA), Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Change in interleukin (IL)-6 in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks
Other	Change in interleukin (IL)-8 in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks
Other	Change in interleukin (IL)-1 beta in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks
Other	Change in tumor necrosis factor (TNF)-alpha in saliva (pg/ml)		Baseline, 12 weeks and 24 weeks
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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