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Clinical Trials/NCT02765542
NCT02765542
Completed
Not Applicable

Developing Accessible mHealth Programs for Depression Management in Bolivia

University of Michigan1 site in 1 country32 target enrollmentJuly 2014
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Michigan
Enrollment
32
Locations
1
Primary Endpoint
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Piette

VA Senior Research Career Scientist, Professor of Health Behavior and Health Education and of Internal Medicine

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)

Time Frame: Baseline and 12 week post-intervention follow-up

Secondary Outcomes

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

Study Sites (1)

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