DAPPER: Depression and Pain Perseverance Through Empowered Recovery Intervention
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) [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.
- Change in Pain Interference as assessed by the PROMIS Pain Interference [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.
- Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9) [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.
- Change in Depressive Symptoms as assessed by the PROMIS 57 [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
- Change in Frailty as assessed by the Frailty Phenotype measure [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).
- Change in Frailty as assessed by the Frail Scale [Baseline, 12 weeks and 24 weeks]
The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more fraility.
- Change in Physical Function as assessed by the Katz Activities of daily living (ADL) [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.
- Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL) [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
- Change in Communication with Health Care Providers as assessed by the Patients' Reaction Assessment [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.
- Change in Stress as assessed by the Perceived Stress Scale [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.
- Change in Social engagement as assessed by the Social Network Scale [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.
- Change in Self Efficacy as assessed by the Coping and Self-Efficacy Scale [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.
- Change in Comorbid Conditions as assessed by the Charlson Comorbidity Index [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.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Self-Identify as African American/Black female
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Live in a community dwelling
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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)
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Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
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One ADL or IADL limitation
Exclusion Criteria:
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Hospitalized > 3 times in the last year
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Participating in physical therapy
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Have a terminal diagnosis (<1 year expected survival)
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moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)
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Unable to speak or understand English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins School of Nursing | Baltimore | Maryland | United States | 21205 |
Sponsors and Collaborators
- Johns Hopkins University
- Robert Wood Johnson Foundation
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Janiece L Taylor, PhD, Johns Hopkins School of Nursing
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00226182
- 75206
- P30AG021334