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Completed

NCT Number: NCT01834534

Telemonitoring Enhanced Support for Depression Self Management

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcona Health Centers, Alpena, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CarePartners for depression

Behavioral

Automated telephone calls for depression monitoring and self-management support.

Primary outcomes

  1. Depressive symptom severity

    Time frame: 12 months after randomization

    Patient Health Questionnaire 9 (PHQ-9).

Secondary outcomes

  1. Depression remission rate

    Time frame: 12 months after randomization

    Remission as measured by PHQ-9 <10

  2. Depression-related functional impairment

    Time frame: 12 months after randomization

    Sheehan Disability Scale

  3. Positive well-being

    Time frame: 12 months after randomization

    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.

  4. Health care costs

    Time frame: 12 months after randomization

    Health care costs will be estimated using data gathered from a variety of patient self-report and site-specific administrative databases.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2013
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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