Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T)
Kittipan Rerkasem,
Sanjay Kinra,
Kara Hanson,
Chaisiri Angkurawaranon,
Iliatha Papachristou Nadal,
Kanokporn Pinyopornpanish,
Orawan Quansri,
Supattra Srivanichakorn,
Win Techakehakij,
Nutchanath Wichit,
Chanapat Pateekhum,
Chanchanok Aramrat,
Wichuda Jiraporncharoen,
Nutchar Wiwatkunupakarn,
Nick Birk,
Elisha Ngetich
Affiliations
Kittipan Rerkasem
NCD Center of Excellence, Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand
Sanjay Kinra
1 Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK
Kara Hanson
Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK
Chaisiri Angkurawaranon
Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Iliatha Papachristou Nadal
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
Kanokporn Pinyopornpanish
Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Orawan Quansri
ASEAN Health Institute for Health Development, Mahidol University, Salaya, Nakhon Pathom, Thailand
Supattra Srivanichakorn
Department of Disease Control, Ministry of Public Health, Bangkok, Nonthaburi, Thailand
Win Techakehakij
Lampang Hospital, Lampang, Thailand
Nutchanath Wichit
Surat Thani Rajabhat University, Surat Thani, Thailand
Chanapat Pateekhum
Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Chanchanok Aramrat
Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Wichuda Jiraporncharoen
Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Nutchar Wiwatkunupakarn
Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Nick Birk
Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine Faculty of Epidemiology and Population Health, London, UK
Elisha Ngetich
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK
Introduction Type 2 diabetes mellitus is a major global challenge, including for Thai policy-makers, as an estimated 4 million people in Thailand (population 68 million) have this condition. Premature death and disability due to diabetes are primarily due to complications which can be prevented by good risk factor control. Diabetes Self-Management Education (DSME) programmes provide patients with diabetes with the necessary knowledge and skills to effectively manage their disease. Currently, a trial is being conducted in Thailand to evaluate the effectiveness, defined as HbA1c<7 at 12 months after enrolment, of a culturally tailored DSME in Thailand. A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context.Methods and analysis The aim of the process evaluation is to understand how and why the intervention was effective or ineffective and to identify contextually relevant strategies for future successful implementation. For the process evaluation, the design will be a mixed-method study collecting data from nurse providers, and village health volunteers (community health workers) as well as patients. This will be conducted using observations, interviews and focus groups from the three purposively selected groups at the beginning and end of trial. Quantitative data will be collected through surveys conducted at the beginning, during 6-month follow-up, and at the end of trial. The mixed-methods analysis will be triangulated to assess differences and similarities across the various data sources. The overall effectiveness of the intervention will be examined using multilevel analysis of repeated measures.Ethics and dissemination Study approved by the Chiang Mai University Research Ethics Committee (326/2018) and the London School of Hygiene & Tropical Medicine (16113/RR/12850). Results will be published in open access, peer-reviewed scientific journals.Trial registration number NCT03938233.
