Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T)

Abstract

IntroductionType 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 analysisThe 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 disseminationStudy 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 numberNCT03938233.

Illness perceptions, self-care practices, and glycemic control among type 2 diabetes patients in Chiang Mai, Thailand

“…In Thailand, behavioral change, and self-management education programs for people with diabetes are often offered in outpatient settings. Current efforts are underway to design and evaluate a scalable diabetes self-management education (DSME) program for primary care in Thailand [ 22 , 23 ]. Not only will programmatic issues need to be addressed, but a successful, widespread diabetes self-management program in Thailand will also need to be guided by behavioral theories and tailored to the local context [ 24 ].…”