Developing Accessible mHealth Programs for Depression Management in Bolivia

Overview

The purpose of the study is to evaluate the feasibility and potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Detailed Description

All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, if possible, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate who will be present. In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected. The intervention will last up to 12 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone.

Interventions

  • Other: Automated disease assessment & self-care support phone calls
    • Automated disease assessment & self-care support phone calls for up to 12 weeks.

Arms, Groups and Cohorts

  • Experimental: Automated phone calls
    • Automated disease assessment & self-care support phone calls for up to 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
    • Time Frame: Baseline and 12 week post-intervention follow-up

Secondary Measures

  • Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
    • Time Frame: Baseline and 12 week post-intervention follow-up
  • Evaluate program feasibility (telephone call completion rates)
    • Time Frame: 12 week post-intervention follow-up
  • Patient satisfaction (satisfaction questionnaire)
    • Time Frame: 12 week Post-intervention follow-up
  • Patient qualitative feedback (qualitative questionnaire)
    • Time Frame: 12 week Post-intervention follow-up

Participating in This Clinical Trial

Inclusion Criteria

  • 21-80 years of age – PHQ-8 score of 10 or higher Exclusion Criteria:
  • Have diagnoses indicating a six-month life expectancy – Prior inpatient psychiatric treatment – Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners
  • Gender Eligibility: All

    Minimum Age: 21 Years

    Maximum Age: 80 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University of Michigan
    • Provider of Information About this Clinical Study
      • Principal Investigator: John Piette, VA Senior Research Career Scientist, Professor of Health Behavior and Health Education and of Internal Medicine – University of Michigan
    • Overall Official(s)
      • John D Piette, PhD, Principal Investigator, University of Michigan

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