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OpenTrials
Completed

NCT Number: NCT02765542

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Servicio Departmental de Salud (SEDES) affiliated clinics

La Paz, Bolivia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated disease assessment & self-care support phone calls

Other

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

Primary outcomes

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

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

Secondary outcomes

  1. Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)

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

  2. Evaluate program feasibility (telephone call completion rates)

    Time frame: 12 week post-intervention follow-up

  3. Patient satisfaction (satisfaction questionnaire)

    Time frame: 12 week Post-intervention follow-up

  4. Patient qualitative feedback (qualitative questionnaire)

    Time frame: 12 week Post-intervention follow-up

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 6, 2016
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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