Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 8, 2024
Open Peer Review Period: Apr 9, 2024 - May 25, 2024
Date Accepted: Jun 18, 2024
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Rationale, design, and intervention development of a mobile health led primary care program for management of type 2 diabetes in rural Thailand: SMARThealth Diabetes study Protocol
ABSTRACT
Background:
Non-communicable diseases (NCDs), particularly diabetes and chronic kidney diseases (CKD), pose a significant health burden in Thailand, especially among socioeconomically disadvantaged populations. The existing primary healthcare system faces challenges in providing optimal care for NCDs due to inadequate primary care workforce. The SMARThealth program offers a technology-based solution to enhance NCD management through task-sharing among non-physician healthcare workers.
Objective:
This study aims to adapt and implement the SMARThealth Diabetes program in rural Thailand to improve diabetes management. The main objectives are: 1) to adapt, validate, and integrate the SMARThealth diabetes program for improving the management of type 2 diabetes mellitus at the primary healthcare level, and 2) to determine the feasibility and acceptability of the SMARThealth diabetes program in rural communities of Thailand.
Methods:
A pragmatic, type 2 hybrid effectiveness / implementation, parallel-group cluster randomized controlled trial of 12 months duration and involving 40 sub-district health offices (SDHOs) in rural communities of Kamphaeng Phet province, Thailand, will be conducted. The intervention arm will receive the SMARThealth Diabetes program, including workforce restructuring, clinical decision support system, and continuous performance monitoring, while the control arm will continue with usual practice. Process evaluation will be conducted to identify factors that promote or inhibit the implementation and maintenance of the programme.
Results:
Primary outcome measure will be the difference in change in mean HbA1C measured at the SDHO between randomisation and 12 months from randomisation between the intervention and control clusters. Secondary outcomes will include the difference in change in albuminuria status; change in eGFR, systolic blood pressure, and LDL cholesterol level; change in the proportion of patients with HbA1c <7%, and patients with SBP<140mmHg; measured at randomisation and 12 months from randomisation, between the intervention and control clusters.
Conclusions:
There is a growing epidemic of diabetes leading to CKD and kidney failure. The study protocol outlines a novel approach to enhancing diabetes management in rural Thailand through digital technology-based interventions that will facilitate task-sharing among healthcare workers. This intervention will address several gaps in the treatment of diabetes and kidney disease, viz. inadequate workforce; disproportionate focus on physician-centric care models not aligned with the values and preferences of communities in which they are implemented; variation in the quality of care and its high cost. Successful implementation of the SMARThealth Diabetes program could demonstrate the effectiveness of the platform in addressing the existing gaps in the diabetes treatment and management. This can help inform future strategies for improving NCD care in low-resource settings globally. Clinical Trial: The trial has been registered with the Thai Clinical Trials Registry under the trial registration number TCTR20200322006.
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Copyright
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