COMMIT Depression Trial Nepal

NCT04510909 | Unknown

• 2 other identifiers: COMMITDNepal1R21MH116728-01A1
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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)

  6 months

• 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).

  2 weeks

• 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).

  2 weeks

Secondary Outcomes (3)

• Application access and completion percentage

  6 months

• Patient encounter duration

  6 months

• Application error/crash percentage

  6 months

Study Arms (1)

Pilot arm

EXPERIMENTAL

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

Other: COMMIT mHealth application

Interventions

COMMIT mHealth application OTHER

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.

Pilot arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Possible: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, San Francisco: collaborator
• Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health: collaborator
• Nyaya Health Nepal: collaborator
• Ministry of Health and Population, Nepal: collaborator

Study Sites (1)

Bayalpata Hospital

Sanfebagar-10, Achham/Province 7, Nepal

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Bibhav Acharya, MD

CONTACT

9176539358; Bibhav.Acharya@ucsf.edu

Duncan Maru, MD, PhD

CONTACT

2128247950; duncan.maru@mssm.edu

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: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: August 12, 2020
• Study Start: August 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)