Clinical trial NCT01834534: Telemonitoring Enhanced Support for Depression Self Management
Official title: Telemonitoring Enhanced Support for Depression Self Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-04-18
Enrollment: 243
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptom severity
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Depression remission rate
timeFrame: 12 months after randomization
measure: Depression-related functional impairment
timeFrame: 12 months after randomization
measure: Positive well-being
timeFrame: 12 months after randomization
measure: Health care costs
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Alpena
country: United States
facility: Alcona Health Centers
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Canton
country: United States
facility: Dua Family Practice
state: Michigan
city: Detroit
country: United States
facility: Morang Chester
state: Michigan
city: Flint
country: United States
facility: Hamilton Community Health Network, Inc.
state: Michigan
city: Grand Rapids
country: United States
facility: Cherry Street Health Services
state: Michigan
city: Muskegon Heights
country: United States
facility: Muskegon Family Care
state: Michigan
Study officials:
affiliation: University of Michigan
name: James E Aikens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: John D Piette, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aikens JE, Valenstein M, Plegue MA, Sen A, Marinec N, Achtyes E, Piette JD. Technology-Facilitated Depression Self-Management Linked with Lay Supporters and Primary Care Clinics: Randomized Controlled Trial in a Low-Income Sample. Telemed J E Health. 2022 Mar;28(3):399-406. doi: 10.1089/tmj.2021.0042. Epub 2021 Jun 4.