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Clinical Trials/NCT05512624
NCT05512624
Recruiting
N/A

Integrating an Evidence-based Mental Health Intervention Into Primary Health Care to Improve Outcomes for Refugees With Hypertension, Diabetes, and Epilepsy

International Rescue Committee1 site in 1 country308 target enrollmentSeptember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
International Rescue Committee
Enrollment
308
Locations
1
Primary Endpoint
Medication Adherence Report Scale
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The objective of this study is to evaluate the impact of an evidence-based mental health intervention (Common Elements Treatment Approach) on medication adherence, behavioral improvement and clinical outcomesamong adults taking medication for hypertension, diabetes and epilepsy using a two-arm randomized wait-list controlled trial among adult refugees in Mae La camp, Thailand.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
September 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A. Inclusion criteria:
  • Patients who was diagnosed by physician based on ICD 10 to have diabetes, hypertension or diabetes with hypertension comorbidity, or epilepsy.
  • Registered in chronic database system of the camp.
  • B. Exclusion criteria:
  • who are younger than 18 years old
  • who have severe physical illness
  • who have severe mental disorders
  • who will not stay in the camp until the end of the program
  • who are not willing to participate in the program

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Medication Adherence Report Scale

Time Frame: Baseline, Endline, Past two weeks

Medication Adherence - Self Report will be assessed using the 5-item Medication Adherence Report Scale (MARS-5). Each item assesses the frequency of deviations in medication use, ranging from never (0) to all days (4) over the past two weeks. The MARS-5 will be scored by calculating the mean of all items to generate a continuous score ranging from 0-4, with higher scores indicating greater problems with medication adherence.

Pill Count Medication Adherence

Time Frame: Baseline, Endline, Past two weeks

Medication Adherence - Pill Count: Measurement: Medication Adherence will also be objectively measured by counting the proportion of pills taken over the past two weeks relative to the number taken if used as prescribed over the same period. Proportions will range from 0-100% with higher proportion indicating greater adherence. Proportions will be used to classify a binary indicator of adherence using an 80% or higher cutoff.

Study Sites (1)

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