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COMMIT Depression Trial Nepal

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
COMMIT mHealth application
Sponsored by
Possible
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring low- and middle-income countries, mHealth, human-centered design and engineering, digital tools, Nepal, motivational interviewing, non-physician healthcare workers, community health workers, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Inclusion criteria for patient population: a. Adult patients aged 18 or older; AND b. Must have with active diagnosis of moderate to severe depression (last PHQ-9 ≥10) in the electronic health record system at the research performance site in Nepal; AND c. Have poor adherence (did not refill medications 1 week past the expected date and/or missed a scheduled clinic visit by at least 2 weeks; AND d. Must reside in Dolakha, Nepal
  2. Inclusion criteria for community health worker or a community health worker supervisor: a. community health workers and their supervisors currently employed by and working at the research performance site, serving communities in Dolakha; AND b. have received training in motivational interviewing and use of the COMMIT mobile application.

Exclusion Criteria:

  1. Exclusion criteria for patient population: patients with bipolar disorder (their treatment will be different from standard antidepressants) and those with substance use or psychotic disorders (their motivational factors will be substantially different from those of other depressed patients).
  2. Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

Sites / Locations

  • Bayalpata Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot arm

Arm Description

Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application

Outcomes

Primary Outcome Measures

Depression
Individual Patient Health Questionnaire-9 score, measured at baseline and endline, with greater than or equal to 10 as moderate to severe depression (min score=0; max scote=27 with higher score corresponding to poorer health status)
Medication refill percentage
Individual depression medication refill percentage over past 2 weeks (percentage of prescribed depression medication not refilled/picked up as measured by limited dataset extraction from electronic health record system; scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to medication refills completed 100% of the time).
Follow-up clinic attendance percentage
Individual attendance at follow-up visits measured as a percentage over past 2 weeks (percentage of indicated follow-up clinic visits that occurred as measured by limited dataset extraction from electronic health record system; scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to patients who attend follow-up visits at clinic 100% of the time).

Secondary Outcome Measures

Application access and completion percentage
Frequency of community health worker accessing mobile application during study (number of times mobile application is accessed/data are entered and completed as a proportion of patients assigned for follow-up)
Patient encounter duration
Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)
Application error/crash percentage
Frequency of mobile application displaying error messages or crashing while in use by community health workers during patient encounters (proportion of all patient encounters where an error message/application crashes occurs)

Full Information

First Posted
July 17, 2020
Last Updated
August 14, 2020
Sponsor
Possible
Collaborators
National Institute of Mental Health (NIMH), University of California, San Francisco, Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health, Nyaya Health Nepal, Ministry of Health and Population, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT04510909
Brief Title
COMMIT Depression Trial Nepal
Official Title
COMMIT Depression Acceptability and Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Possible
Collaborators
National Institute of Mental Health (NIMH), University of California, San Francisco, Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health, Nyaya Health Nepal, Ministry of Health and Population, Nepal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Community health workers (CHWs) have successfully used Motivational Interviewing (MI) to improve treatment adherence (i.e. taking medications and attending clinic appointments) for patients with depression in the US and globally. Mobile health (mHealth) tools can address challenges in implementing MI by providing real-time support in the community and facilitating ongoing coaching and supervision for CHWs, as these two challenges currently impede CHWs' ability to use MI. The investigators will develop then test a new mHealth app, which can potentially be used in the US and abroad, to help CHWs receive decision-support for MI and capture consented audio recordings of patient interactions for review and feedback by facility-based nurses with MI expertise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
low- and middle-income countries, mHealth, human-centered design and engineering, digital tools, Nepal, motivational interviewing, non-physician healthcare workers, community health workers, depression

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
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot arm
Arm Type
Experimental
Arm Description
Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application
Intervention Type
Other
Intervention Name(s)
COMMIT mHealth application
Intervention Description
The investigators will develop Community-based mHealth Motivational Interviewing Tool (COMMIT) using iterative design and testing with frequent, structured input from the key stakeholders: community health workers (CHWs), their supervisors and adult depression patients.The tool will be used by community CHWs in Dolakha, Nepal to: 1) obtain decision-support to deliver motivational interviewing (MI) for patients in their communities, and 2) capture consented audio recordings of client interactions for review and feedback by their supervisors, allowing CHWs to maintain MI skills beyond the initial training period.
Primary Outcome Measure Information:
Title
Depression
Description
Individual Patient Health Questionnaire-9 score, measured at baseline and endline, with greater than or equal to 10 as moderate to severe depression (min score=0; max scote=27 with higher score corresponding to poorer health status)
Time Frame
6 months
Title
Medication refill percentage
Description
Individual depression medication refill percentage over past 2 weeks (percentage of prescribed depression medication not refilled/picked up as measured by limited dataset extraction from electronic health record system; scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to medication refills completed 100% of the time).
Time Frame
2 weeks
Title
Follow-up clinic attendance percentage
Description
Individual attendance at follow-up visits measured as a percentage over past 2 weeks (percentage of indicated follow-up clinic visits that occurred as measured by limited dataset extraction from electronic health record system; scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to patients who attend follow-up visits at clinic 100% of the time).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Application access and completion percentage
Description
Frequency of community health worker accessing mobile application during study (number of times mobile application is accessed/data are entered and completed as a proportion of patients assigned for follow-up)
Time Frame
6 months
Title
Patient encounter duration
Description
Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)
Time Frame
6 months
Title
Application error/crash percentage
Description
Frequency of mobile application displaying error messages or crashing while in use by community health workers during patient encounters (proportion of all patient encounters where an error message/application crashes occurs)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for patient population: a. Adult patients aged 18 or older; AND b. Must have with active diagnosis of moderate to severe depression (last PHQ-9 ≥10) in the electronic health record system at the research performance site in Nepal; AND c. Have poor adherence (did not refill medications 1 week past the expected date and/or missed a scheduled clinic visit by at least 2 weeks; AND d. Must reside in Dolakha, Nepal Inclusion criteria for community health worker or a community health worker supervisor: a. community health workers and their supervisors currently employed by and working at the research performance site, serving communities in Dolakha; AND b. have received training in motivational interviewing and use of the COMMIT mobile application. Exclusion Criteria: Exclusion criteria for patient population: patients with bipolar disorder (their treatment will be different from standard antidepressants) and those with substance use or psychotic disorders (their motivational factors will be substantially different from those of other depressed patients). Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bibhav Acharya, MD
Phone
9176539358
Email
Bibhav.Acharya@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Duncan Maru, MD, PhD
Phone
2128247950
Email
duncan.maru@mssm.edu
Facility Information:
Facility Name
Bayalpata Hospital
City
Sanfebagar-10
State/Province
Achham/Province 7
Country
Nepal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabitri Sapkota, PhD, MPH
Phone
+977 14100597
Email
sabitri.sapkota@nyayahealthnepal.org

12. IPD Sharing Statement

Plan to Share IPD
No

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COMMIT Depression Trial Nepal

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