COMMIT Depression Trial Nepal

Not Applicable

• Conditions: Depression
• Interventions: Other: COMMIT mHealth application

• Registration Number: NCT04510909
• Lead Sponsor: Possible

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-17
• Status Verified: 2020-08
• Study Start: 2020-08
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-12
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-18
• Primary Completion: 2021-01
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot arm	COMMIT mHealth application	Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application

Primary Outcome Measures

Name	Time	Method
Depression	6 months	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)
Follow-up clinic attendance percentage	2 weeks	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).
Medication refill percentage	2 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Patient encounter duration	6 months	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	6 months	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)
Application access and completion percentage	6 months	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)

Trial Locations

Locations (1)

Bayalpata Hospital; 🇳🇵 Sanfebagar-10, Achham/Province 7, Nepal