Developing Accessible mHealth Programs for Depression Management in Bolivia

NCT ID: NCT02765542

Last Updated: 2016-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Automated phone calls

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

Group Type: EXPERIMENTAL

Automated disease assessment & self-care support phone calls

Intervention Type: OTHER

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

Interventions

Automated disease assessment & self-care support phone calls

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

John Piette

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John D Piette, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

El Servicio Departmental de Salud (SEDES) affiliated clinics

La Paz, , Bolivia

Countries

Bolivia

Other Identifiers

HUM00087937

Identifier Type: -

Identifier Source: org_study_id