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Depression and Pain Perseverance Through Empowered Recovery Intervention (DAPPER)

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ClinicalTrials.gov Identifier: NCT04091347
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
African American women 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.

Condition or disease Intervention/treatment Phase
Pain Depressive Symptoms Frailty Aging Behavioral: DAPPER Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Pilot Study of Depression and Pain Perseverance Through Empowered Recovery (DAPPER) Intervention
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Open Label Pilot Arm
Three participants will receive the intervention in the open label pilot. The participants will receive half of the visits (4 visits) and this will occur over 6 weeks.
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.

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.




Primary Outcome Measures :
  1. Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.

  2. Change in Pain Interference as assessed by the PROMIS Pain Interference [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  3. Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  4. Change in Depressive Symptoms as assessed by the PROMIS 57 [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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 :
  1. Change in Frailty as assessed by the Frailty Phenotype measure [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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).

  2. Change in Physical Function as assessed by the Katz Activities of daily living (ADL) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  3. Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.


Other Outcome Measures:
  1. Change in Communication with Health Care Providers as assessed by the Patients' Reaction Assessment [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  2. Change in Stress as assessed by the Perceived Stress Scale [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  3. Change in Social engagement as assessed by the Social Network Scale [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  4. Change in Self Efficacy as assessed by the Coping and Self-Efficacy Scale [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  5. Change in Comorbid Conditions as assessed by the Charlson Comorbidity Index [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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.

  6. Change in interleukin (IL)-6 in saliva (pg/ml) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  7. Change in interleukin (IL)-8 in saliva (pg/ml) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  8. Change in interleukin (IL)-1 beta in saliva (pg/ml) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  9. Change in tumor necrosis factor (TNF)-alpha in saliva (pg/ml) [ Time Frame: Baseline, 12 weeks and 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091347


Contacts
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Contact: Janiece Taylor, PhD 443-287-4503 jwalke90@jhu.edu
Contact: Sarah Szanton, PhD 410-502-2605 sarah.szanton@jhu.edu

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

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04091347     History of Changes
Other Study ID Numbers: IRB00226182
75206 ( Other Grant/Funding Number: Robert Wood Johnson Harold Amos Medical Faculty Program )
P30AG021334 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
African American
Women's Health
Additional relevant MeSH terms:
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Frailty
Depression
Behavioral Symptoms
Pathologic Processes