Developing Accessible mHealth Programs for Depression Management in Bolivia
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Bolivia
Study Type
Interventional
Intervention
Automated disease assessment & self-care support phone calls
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring Depression, mHealth, Interactive Voice Response, Bolivia, Mental health
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
Sites / Locations
- El Servicio Departmental de Salud (SEDES) affiliated clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Automated phone calls
Arm Description
Automated disease assessment & self-care support phone calls for up to 12 weeks.
Outcomes
Primary Outcome Measures
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
Secondary Outcome Measures
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
Evaluate program feasibility (telephone call completion rates)
Patient satisfaction (satisfaction questionnaire)
Patient qualitative feedback (qualitative questionnaire)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02765542
Brief Title
Developing Accessible mHealth Programs for Depression Management in Bolivia
Official Title
Developing Accessible mHealth Programs for Depression Management in Bolivia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, mHealth, Interactive Voice Response, Bolivia, Mental health
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Automated phone calls
Arm Type
Experimental
Arm Description
Automated disease assessment & self-care support phone calls for up to 12 weeks.
Intervention Type
Other
Intervention Name(s)
Automated disease assessment & self-care support phone calls
Intervention Description
Automated disease assessment & self-care support phone calls for up to 12 weeks.
Primary Outcome Measure Information:
Title
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
Time Frame
Baseline and 12 week post-intervention follow-up
Secondary Outcome Measure Information:
Title
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
Time Frame
Baseline and 12 week post-intervention follow-up
Title
Evaluate program feasibility (telephone call completion rates)
Time Frame
12 week post-intervention follow-up
Title
Patient satisfaction (satisfaction questionnaire)
Time Frame
12 week Post-intervention follow-up
Title
Patient qualitative feedback (qualitative questionnaire)
Time Frame
12 week Post-intervention follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Piette, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Servicio Departmental de Salud (SEDES) affiliated clinics
City
La Paz
Country
Bolivia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing Accessible mHealth Programs for Depression Management in Bolivia
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