NCT02765542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

March 4, 2015

Last Update Submit

May 4, 2016

Conditions

Depression

Keywords

DepressionmHealthInteractive Voice ResponseBoliviaMental health

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 12 week post-intervention follow-up

Secondary Outcomes (4)

  • 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

Study Arms (1)

Automated phone calls

EXPERIMENTAL

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

Other: Automated disease assessment & self-care support phone calls

Interventions

Automated disease assessment & self-care support phone callsOTHER

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

Automated phone calls

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • PHQ-8 score of 10 or higher

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Servicio Departmental de Salud (SEDES) affiliated clinics

La Paz, Bolivia

Location

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • John D Piette, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VA Senior Research Career Scientist, Professor of Health Behavior and Health Education and of Internal Medicine

Study Record Dates

First Submitted

March 4, 2015

First Posted

May 6, 2016

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BO(1)