Telemonitoring Enhanced Support for Depression Self Management

Study Overview
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Brief Summary
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The objective of this research is to test the efficacy of CarePartners for Depression (CP-D) intervention, which was designed to increase between visit monitoring of depression status and enhance self-management. **In order to participate, subjects must be patients at participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.

Detailed Description
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This project will test a practical intervention that uses low cost technologies to activate depressed patients' existing social networks for self-management support. The intervention links patients with a CarePartner (CP), i.e., a non-household family member or close friend who is willing to support the patient in coordination with the clinician and any existing in-home caregiver (ICG). Through weekly automated telemonitoring, patients report their mood and self-management status, and receive tailored guidance on self-management. The CP receives a corresponding update along with guidance on how to best support the patient's self-management efforts, and the primary care team is notified about clinically urgent situations. The intervention will be tested among depressed primary care patients from clinics serving low-income and underinsured patients, whom the intervention was especially designed to benefit. Specific Aim 1 is to conduct a randomized controlled trial to compare the effectiveness of one year of telemonitoring-supported CP for depression versus usual care (control) on depression severity. Specific Aim 2 is to examine key secondary outcomes (response and remission, impairment, well-being, caregiving burden, healthcare costs) and potential moderators. Specific Aim 3 is to use a mixed-methods approach to enrich our interpretation of the statistical associations, and to discover strategies to enhance the intervention's acceptability, effectiveness, and sustainability. If the intervention proves effective without increasing clinician burden or marginal costs, then its subsequent implementation could yield major public health benefits, especially in medically underserved populations.

Official Title
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Telemonitoring Enhanced Support for Depression Self Management

Conditions
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Depression

Intervention / Treatment
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* Behavioral: CarePartners for depression


Participation Criteria
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Eligibility Criteria
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NOTE: In order to participate, must have received medical care for past year at one of the participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester Additional Inclusion Criteria: at least 2 outpatient primary care visits in the past 2 years, 1 within the past 13 months depression diagnosis in medical chart problem list or billing record (ICD9 codes: 296.20-.26, .30-.36, 296.4-.9, 298.0, 300.4, 309.0-.1, 309.28, 311.00) during the past 2 years current PHQ >10 (non-mild depressive symptoms) at least 21 years old comfortable speaking English can use a touch-tone phone can identify at least 1 eligible CarePartner not in palliative care, on transplant waitlist, or <1 year life expectancy free of major cognitive impairment or psychiatrically unstable not experiencing domestic abuse or stalking Exclusion Criteria: Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage renal disease), receiving palliative care At risk for domestic abuse, PHQ<10, end stage renal disease, lung cancer, dementia, bipolar disease, schizophrenia, limited life expectancy (advanced stage cancer/heart failure/on oxygen), alcohol problems, receiving palliative care Unable to speak English Not planning to get all or most of care at study site Primary care physician not affiliated with study site Unable to use telephone to respond to weekly automated self-management support calls Unable to nominate an eligible CP

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CarePartners for depression<br>For one year, patients receive weekly automated telemonitoring of mood and self-management, while their CarePartners receive weekly reports of the patient's assessment results with tailored instructions on supporting the patient's depression self-management. | Behavioral: CarePartners for depression<br>* Automated telephone calls for depression monitoring and self-management support.<br>|
| No Intervention: Usual care<br>Usual medical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptom severity | Patient Health Questionnaire 9 (PHQ-9). | 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression remission rate | Remission as measured by PHQ-9 <10 | 12 months after randomization | 
| Depression-related functional impairment | Sheehan Disability Scale | 12 months after randomization | 
| Positive well-being | Positive well-being will be assessed using the REMIT, a 5-item scale of positive affect and other aspects of depression recovery developed by the PI and his colleagues. Reference: Nease DE, Jr., Aikens, JE, Klinkman, MK, Kroenke, K, and Sen, A. Toward a more comprehensive assessment of depression remission: the Remission Evaluation and Mood Inventory Tool (REMIT). Journal of General Hospital Psychiatry. 2011. | 12 months after randomization | 
| Health care costs | Health care costs will be estimated using data gathered from a variety of patient self-report and site-specific administrative databases. | 12 months after randomization |