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
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Published version
Author(s)
Type
Journal Article
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.
Objectives: 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. Data will be collected using the SMARThealth platform and will be stored on a server in Thailand. The primary outcome measure will be the change in mean HbA1C measured at randomisation and 12 months from randomisation between the intervention and control clusters. Secondary outcomes will include the difference in change in albuminuria status, estimated glomerular filtration rate (eGFR), systolic blood pressure (SBP), and LDL cholesterol level. The analysis for change in HbA1c between baseline and end of study will be performed using linear mixed models. Any imbalances between the two arms will be addressed by sensitivity analyses. Additionally, a mixed methods process evaluation will be conducted to assess the implementation process, that will include in-depth interviews and focus group discussions in addition to the quantitative data collected during the implementation process. The qualitative data will be thematically analysed to explore factors that promote or inhibit the implementation and maintenance of the program.
Results: Data collection commenced in November 2022 and the results will be ready for publication by first quarter of 2025. Effectiveness of the intervention package will be assessed by change in mean HbA1C measures, and detailed feasibility, barriers and enablers for the implementation of the intervention will be documented through a detailed process evaluation.
Conclusion: 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 can help inform future strategies for improving NCD care in low-resource settings globally.
Trial registration : The trial has been registered with the Thai Clinical Trials Registry under the trial registration number TCTR20200322006.
Objectives: 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. Data will be collected using the SMARThealth platform and will be stored on a server in Thailand. The primary outcome measure will be the change in mean HbA1C measured at randomisation and 12 months from randomisation between the intervention and control clusters. Secondary outcomes will include the difference in change in albuminuria status, estimated glomerular filtration rate (eGFR), systolic blood pressure (SBP), and LDL cholesterol level. The analysis for change in HbA1c between baseline and end of study will be performed using linear mixed models. Any imbalances between the two arms will be addressed by sensitivity analyses. Additionally, a mixed methods process evaluation will be conducted to assess the implementation process, that will include in-depth interviews and focus group discussions in addition to the quantitative data collected during the implementation process. The qualitative data will be thematically analysed to explore factors that promote or inhibit the implementation and maintenance of the program.
Results: Data collection commenced in November 2022 and the results will be ready for publication by first quarter of 2025. Effectiveness of the intervention package will be assessed by change in mean HbA1C measures, and detailed feasibility, barriers and enablers for the implementation of the intervention will be documented through a detailed process evaluation.
Conclusion: 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 can help inform future strategies for improving NCD care in low-resource settings globally.
Trial registration : The trial has been registered with the Thai Clinical Trials Registry under the trial registration number TCTR20200322006.
Date Issued
2024
Date Acceptance
2024-06-18
Citation
JMIR Research Protocols, 2024, 13
ISSN
1929-0748
Publisher
JMIR Publications
Journal / Book Title
JMIR Research Protocols
Volume
13
Copyright Statement
©Methee Chanpitakkul, Devarsetty Praveen, Renu John, Arpita Ghosh, Salyaveth Lekagul, Malulee Kaewhiran, Kriang Tungsanga, Vivekanand Jha. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.08.2024.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
License URL
Identifier
https://www.researchprotocols.org/2024/1/e59266
Publication Status
Published
Article Number
e59266
Date Publish Online
2024-06-16