Developing Accessible mHealth Programs for Depression Management in Bolivia

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 Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Automated disease assessment & self-care support phone calls

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bolivia
  • La Paz, Bolivia
    • El Servicio Departmental de Salud (SEDES) affiliated clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated phone calls; Automated disease assessment & self-care support phone calls for up to 12 weeks.	Other: Automated disease assessment & self-care support phone calls; Automated disease assessment & self-care support phone calls for up to 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)	Baseline and 12 week post-intervention follow-up
Evaluate program feasibility (telephone call completion rates)	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: John D Piette, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Depression; mHealth; Mental health; Bolivia; Interactive Voice Response
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: HUM00087937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO