A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: London School of Hygiene and Tropical Medicine

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                                                                                     TRIAL PROTOCOL 
Thailand 
 
 
 
A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand 
 
 
ISRCTN 
NCT (clinicaltrials.gov) 
 
DSME Thailand 
 
 
Version 1.0 (08th October 2018) 
 
 
SPONSOR: London School of Hygiene & Tropical Medicine (LSHTM) 
 
FUNDERS: UK Medical Research Council (MRC) and the Thailand Research Fund (TRF) 
 
STUDY COORDINATION CENTRE: London School of Hygiene and Tropical Medicine (UK) 
Chiang Mai University UNLISTED (Thailand) 
 
LSHTM Ethics Reference: 16113/RR/12850 
 
 
 

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Table of Contents 
LIST OF ABBREVIATIONS ....................................................................................................................... 4 
STATEMENT OF COMPLIANCE .............................................................................................................. 4 
PROTOCOL SUMMARY ......................................................................................................................... 4 
SCHEMATIC OF STUDY DESIGN ............................................................................................................. 6 
1. KEY ROLES ........................................................................................................................................ 6 
2.  INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ................................ 7 
2.1 BACKGROUND INFORMATION................................................................................................................. 7 
2.2 RATIONALE .............................................................................................................................................. 8 
3.  STUDY OBJECTIVES .......................................................................................................................... 8 
4.   STUDY DESIGN ................................................................................................................................ 9 
4.1 DESCRIPTION OF THE STUDY DESIGN ...................................................................................................... 9 
4.1.1 STUDY OUTCOME MEASURES ............................................................................................................................ 9 
4.1.2 SETTING ............................................................................................................................................................ 9 
5. RANDOMISATION ............................................................................................................................. 9 
6.   SELECTION AND WITHDRAWAL OF PARTICIPANTS.......................................................................... 9 
6.1 INCLUSION CRITERIA ............................................................................................................................... 9 
6.2 EXCLUSION CRITERIA ..............................................................................................................................10 
6.3 CONSENT ................................................................................................................................................10 
6.4 RISKS AND BENEFITS...............................................................................................................................10 
6.5 WITHDRAWAL CRITERIA .........................................................................................................................10 
7.  INTERVENTION .............................................................................................................................. 10 
7.1 INTERVENTION DESCRIPTION AND DELIVERY .........................................................................................10 
8.       ASSESSMENT AND FOLLOW-UP .................................................................................................. 12 
8.1 LOSS TO FOLLOW UP ..............................................................................................................................12 
9.   STATISTICS AND DATA ANALYSIS .................................................................................................. 13 
9.1. SAMPLE SIZE CALCULATION...................................................................................................................13 
9.2. FORMAT AND SCALE OF THE DATA........................................................................................................13 
10.       DATA QUALITY AND STANDARDS ............................................................................................ 13 
10.1. DATA MANAGEMENT ..........................................................................................................................13 
10.2. DATA ANALYSIS ...................................................................................................................................14 
10.2.1 QUANTITATIVE ANALYSIS............................................................................................................................... 14 
10.2.2 QUALITATIVE ANALYSIS ................................................................................................................................. 14 
10.3. DATA STORAGE ...................................................................................................................................14 
10.4. MONITORING ......................................................................................................................................14 
11.  REGULATORY ISSUES ................................................................................................................... 14 
11.1 ETHICS APPROVAL ................................................................................................................................14 

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11.2 CONSENT ..............................................................................................................................................15 
11.3 CONFIDENTIALITY .................................................................................................................................15 
11.4 INDEMNITY ...........................................................................................................................................15 
11.5 SPONSER...............................................................................................................................................15 
11.6. FUNDING .............................................................................................................................................15 
11.7. AUDITS AND INSPECTIONS ..................................................................................................................16 
12. TRIAL MANAGEMENT ................................................................................................................... 16 
12.1      TRIAL MANAGEMENT GROUP ..........................................................................................................16 
12.2     TRIAL MANAGEMENT COMMITTEE ...................................................................................................16 
12.3 DATA MONITORING AND SAFETY OVERSIGHT ......................................................................................16 
12.4 LOCAL MANAGEMENT ..........................................................................................................................16 
13.  PUBLICATION POLICY ................................................................................................................... 17 
14. CONFLICT OF INTEREST POLICY ..................................................................................................... 17 
15.  LITERATURE REFERENCE .............................................................................................................. 17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                            
 
 

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RCT 
Randomised controlled trial 
DSME 
Diabetes Self-Management Education 
BMI 
Body Mass Index 
MRC 
Medical Research Council 
LSHTM 
London School of Hygiene and Tropical Medicine 
CMU 
Chiang Mai University 
TMG 
Trial Management Group  
TSC 
Trial Steering Committee 
CSV 
Comma Separated Value  
WS 
Workstream  
HbA1c 
Haemoglobin A1c levels 
LTFUP 
Lost to Follow up 
IRB 
Institution Review Board  
 
 
 
 
The study will be carried out in accordance with Good Clinical Practice (GCP) as required by the following:  
•   UK Policy Framework for Health and Social Care Research applicable to clinical trials. 
•   SI 2004/1031, Schedule 1, Part 2, 8. 
•   Medicines for Human Use (Clinical Trials) (2004) regulations . 
 
 
TITLE A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand 
(DSME Thailand) 
DESIGN 3 Arm Cluster randomised controlled trial 
AIMS To develop a culturally-tailored DSME program for Thailand and evaluate its clinical and 
cost-effectiveness under two alternative modes of delivery: nurse-led and peer-led. 
OUTCOME MEASURES 
1. Biophysical data: HbA1C; blood glucose and lipids; BMI; Waist circumference; 
blood pressure.  
2. Psychosocial and lifestyle data: Quality of life (WHOQOLBREF and EQ-5D); 
depression and stress (Hospital Anxiety and Depression scale and Perceived 
stress questionnaire); Diabetes knowledge and skills Brief diabetes illness 
perception questionnaire, Diabetes Self-Management Education and Support 
(DMSES), Summary of Diabetes self-care activities questionnaire (SDSCA); Diet 
(24 Hour Food Recall); smoking; physical activity (International Physical Activity 
Questionnaire). 
3.  Intervention related data: satisfaction with delivery of educational sessions 
(Modified Medical Interview Satisfaction scale); peer support (Family and 
Friends subscale of Chronic Illness Resources survey). 
POPULATION Patients attending clinics in Chiang Mai and Lampang province in Northern Thailand 
ELIGIBILITY Adults newly diagnosed type 2 diabetes and those with poor controlled type 2 diabetes 
within three years of diagnosis, across 21 primary care units in the Chiang Mai and 
Lampang province of Thailand. 
INTERVENTION 
Educational/behavioural film-based intervention, delivered to health care 
professionals, health volunteers and newly diagnosed diabetes patients and those with 
poor control within three years of diagnosis plus family 
TRIAL DURATION 36 months 
LIST OF ABBREVIATIONS 
STATEMENT OF COMPLIANCE  
PROTOCOL SUMMARY

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STUDY SYNOPSIS 
 
Type 2 diabetes is amongst the foremost challenges facing policy makers in Thailand, accounting for 
considerable death, disability and healthcare expenditure. Under Thailand's strong primary health system, 
medical management of diabetes is widely available. However, control of blood glucose and other 
cardiovascular disease risk factors, and regular screening for early detection of complications remain low due 
to a lack of services for education and counselling to support behavioural changes necessary for good self-
management of the condition. A substantial literature documents the effectiveness of Diabetes Self-
Management Education (DSME) programs for improving diabetes outcomes, although little high-quality data 
are available in Thailand, and traditional delivery models (health-professional led one-to-one or small-group 
sessions) are unlikely to be scalable in Thailand given current human resource and budgetary 
constraints. Thus, we propose to develop a low-cost DSME program and scalable delivery model for roll-out 
within the Thai primary care system.   
The intervention is based on behaviour-change and social support theories. This will be delivered in monthly 
group meetings by lay health workers or nurses, and aided by a suite of short films to introduce key topics and 
stimulate discussion. We will randomise 21 primary care units to offer DSME to adults diagnosed newly 
diagnosed with type 2 diabetes and those with poor controlled type 2 diabetes diagnosed within the first three 
years. This will be delivered by lay health workers, nurses (for comparative effectiveness), or usual care. After 
12 months, we will compare glycaemic control and cardiovascular risk scores between the three arms. We will 
conduct cost-effectiveness, process and policy evaluations to produce best-buy recommendations for the Thai 
Ministry of Public Health.   
Through our 3-arm trial design, we will be able to compare effectiveness of nurse-, peer-delivered and standard 
care, and this along with the process evaluation will provide important lessons for the field of peer-delivery of 
interventions. In particular, questions remain whether peer educators can be easily trained to effectively 
deliver state-of-the-art behavioural counselling techniques based on a manualised intervention. The potential 
for peers to offer long-term support, which might better sustain behaviour change, is also untested and will be 
investigated through our process evaluation.   
While there is much interest in theory-based behaviour change, it is relatively unquestioned whether 
approaches will be applicable in diverse cultural contexts, which may also have different baseline levels of 
health education, self-efficacy, social support, etc. Ethnographic observations and follow-up interviews with 
health workers and participants will explore this issue and produce findings relevant to the psychological 
theory-based behaviour change field. To ensure that our work reaches a range of academic beneficiaries, we 
plan to publish our findings in high-impact open access medical, psychological and health policy journals. We 
will share our study data with other researchers, advertising via our publications and web 
presence. In particular, we are committed to sharing our findings and data with academic audiences in Thailand 
and other LMICs.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Methodology and experimental design annex 
 
 
 
 
Trial Management Group 
Chief Investigator 
Professor Sanjay Kinra, London School of Hygiene and Tropical 
Medicine 
email: sanjay.kinra@lshtm.ac.uk 
Principle Investigator (Thailand Lead) 
Dr Charisi Angkurawaranon, Department of Family Medicine, 
Chiang Mai University 
email: chaisiri.a@cmu.ac.th 
Co-Investigator  
Professor Kara Hanson, London School of Hygiene and Tropical 
Medicine 
Co-Investigator 
Professor Kamlesh Khunti, University of Leicester  
Co-Investigator 
Dr Kanokporn Pinyopornpanish, Chiang Mai University 
Co-Investigator 
Ms Orawan Quansri, Mahidol University 
Co-Investigator 
Professor Kittipan Rerkasem, Chiang Mai University 
Co-Investigator 
Dr Supattra Srivanichakorn, Ministry of Public Health, Thailand 
Co-Investigator 
Dr Win Techakehakij, Ministry of Public Health, Thailand 
Co-Investigator 
Dr. Nutchanath Wichit, Suratthanni Rajabhat University 
Study Coordinator (Thailand) 
Dr Kanokporn Pinyopornpanish, Chiang Mai University 
Email: kpinyopo@gmail.com 
 
Study Coordinator and Research 
Fellow (UK) 
Dr Iliatha Papachristou, London School of Hygiene and Tropical 
Medicine 
Email: iliatha.papachristounadal@lshtm.ac.uk 
Study Statistician 
Ms Chanapat Pateekhum, Chiang Mai University 
 
1. KEY ROLES
Follow-up 
21 primary care units from  primary care networks in 2 
provinces 
7 implement nurse-
led DSME program 
7 implement peer-
led DSME program 
7 maintain usual 
care for diabetes 
Persons with newly diagnosed diabetes or with poor control of their 
diabetes within three years of diagnsis over a 6-month period invited 
Outcome measurement at baseline, 6 and 12 months 
Recruitment Randomization Centre recruitment 
Figure 1: Trial flow diagram 
Refusal or loss to follow up (up to 20%) 
Randomization 
Process evaluation 
SCHEMATIC OF STUDY DESIGN

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Type 2 diabetes mellitus (hereto referred to as diabetes) is amongst the foremost health challenges facing 
policy makers in Thailand. The prevalence of diabetes has more than tripled over the last two decades with an 
estimated 4 million adults (age-adjusted prevalence 7.1%) living with diabetes in 2015.1,2   
Diabetes is associated with several macro vascular (e.g. ischaemic heart disease) and microvascular 
complications (e.g. nephropathy, retinopathy, neuropathy, and foot disease). This primarily accounts for the 
considerable death and disability (of which diabetes is the 5th leading cause in Thailand), two-fold higher 
healthcare expenditure, and loss of economic productivity (of persons with diabetes and their carers) 
associated with this condition in Thailand.1–4  
The complications of diabetes can be largely prevented or delayed by good control of their risk factors (blood 
glucose, lipids and blood pressure), through lifestyle change and medication where necessary, and regular 
screening for early detection and management of complications.3,4   
Under Thailand’s universal health coverage, nearly everyone diagnosed with diabetes receives timely medical 
care (>97%) and has access to screening. Yet, surveys suggest that only about half of the people with diabetes 
achieve optimal control of risk factors (e.g. HbA1C <7% in 33%, LDL cholesterol<100 mmol/L in 44%, BP<130/80 
mmHg in 52%). Alternatively, they receive annual screening for microvascular complications (53-
60%).1,5 Limited data support a lack of engagement and self-management skills among those diagnosed with 
diabetes as the main underlying reasons for this.6  
 
Successful management of diabetes involves a considerable degree of self-management.  
People with diabetes need to adhere to multiple behaviours, including healthy lifestyles, regular monitoring 
and medication, problem solving and healthy coping. In this, they are greatly supported by diabetes self-
management education (DSME), defined as 'a collaborative and ongoing process intended to facilitate the 
development of knowledge, skills, and abilities that are required for successful self-management of diabetes'.7   
 Evidence from over 100 studies, including many randomised controlled trials, conducted predominantly in 
high-income countries, suggests that DSME programs are associated with improvements in a range of 
behavioural (knowledge, behaviours, self-efficacy, psychosocial) and clinical (physiological risk factors, 
screening for complications, quality of life) outcomes, 8,9 and are also cost-effective;10 therefore, they 
are recommended by most clinical guidelines.7  
 
Despite this, there is considerable heterogeneity in the effectiveness of DSME programs.8,9  
Programs that are more effective usually offer more than 10 hours contact, incorporate 
behavioural approaches, and provide longer-term support mechanisms. Providing intensive and 
sustained support however has cost implications, resulting in ongoing efforts to identify more cost-
efficient ways to deliver DSME, notably through digital technology (with variable effectiveness) and peers.  
Peers can support sustained changes in complex health behaviours by providing assistance in daily 
management, social and emotional support, linkage to clinical care, and ongoing availability of 
support.11,12  Unlike the educational/psychological framework of professional support, peer support operates 
on a social support framework. Although traditionally restricted to those with experience of disease, the 
definition of peers has been expanded to include other non-professionals with close relations to the 
community (e.g. community health workers).13 However, despite widespread interest, empirical data on 
effectiveness of peers in supporting behaviour change in chronic diseases, including diabetes, is limited and 
inconsistent. 11,12 In an earlier review, the World Health Organisation did not find sufficient evidence to 
recommend peer support programs as a policy option for diabetes management in LMICs.14 Data on cost-
effectiveness, acceptability and potential adverse consequences of peer support programs from diverse 
settings, as well as optimal strategies for mobilising and integrating peers in diabetes care pathways, 
are lacking.12  
  
Since the 1960s, community health workers (called village health volunteers) have been a regular part of the 
Thai healthcare system, linking communities with healthcare providers and providing a range of assistance and 
2. INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
2.1 BACKGROUND INFORMATION 

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outreach services. The presence of a nationwide network of community health workers (1 million) offers a 
unique opportunity to develop a scalable model of DSME provision, while building local capacity, and 
generating critical data on role of peer support programs in LMICs. Taking a similar approach, a multi-country 
demonstration project in 2010, successfully trained village health volunteers in Thailand for DSME 
delivery.15 The study authors reported a substantial engagement and acceptance of the program; however, 
clinical outcomes could not be robustly evaluated due to fieldwork challenges (before-after data were available 
for 53 participants only).  
 
In Thai healthcare system, structured DSME is not routinely available (other than brief didactic educational 
sessions in some centres). While several small-scale studies from Thailand have demonstrated, that DSME can 
strengthen self-management of diabetes, negative perceptions of educational programs (potentially sustained 
in the absence of high-quality local data on effectiveness). These concerns about the burden on existing staff 
time and costs, have so far prevented the introduction of DSME.1,16  However, recent policy developments in 
Thailand are supportive of DSME introduction, if a scalable model can be found. The Thailand Healthy Lifestyles 
Strategic plan (2011-20) lists reduction of diabetes incidence, complications, disability, mortality, and expense 
as one of its five main development goals. The current primary healthcare reform of 2017 integrates clinicians, 
public health staff, and community health workers into primary care clusters to provide community-based and 
multidisciplinary care; a particular focus is on care of non-communicable diseases and people with disability 
through improvements in health literacy and self-efficacy.  
  
 
 
The health and economic consequences of Type 2 diabetes mellitus are largely attributable to its complications, 
which may be prevented or delayed through good disease control. This can be achieved through medical care 
and self-management. Diabetes Self-Management Education (DSME) programs are effective and cost-effective, 
and part of standard care in high-income countries, but are unavailable in Thai healthcare system, despite 
universal coverage of medical aspects of diabetes care. Negative perceptions of educational programs, 
sustained by a lack of high-quality local data, and concerns about burden on existing staff time and costs are 
thought to be responsible.   
  
Given the focus on community-based education for chronic diseases in recent primary healthcare reforms, it is 
timely to scale-up DSME in Thailand, if an affordable model of delivery for a locally-tailored intervention can be 
found. Taking this opportunity, we propose to work in close collaboration with the Thai Ministry of Public 
Health to develop, pilot and evaluate a peer-based DSME program and delivery model, finally producing a list 
of policy recommendations for optimal integration into the Thai healthcare system. Participants will be free to 
drop into any number of meetings (full or partial) and encouraged to contact their nurse or village health 
volunteer for advice as necessary. While there is a theoretical risk that this could increase the cost of the 
program, it is anticipated that it will be regulated by the unwillingness of the participants to attend the 
program beyond its usefulness; identifying this potential unintended consequence will form part of our process 
evaluation.  
 
The proposal is to develop a culturally tailored DSME program for Thailand and evaluate its clinical and cost-
effectiveness under two alternative modes of delivery: nurse-led and peer-led.  
While the exact structure of the intervention will be determined by the formative research carried out under 
this proposal, a low-impact and sustained delivery model is most likely to achieve our twin objectives of long-
term behaviour change and scalability.17   
 
 
 
 
The aim is to identify a scalable model for delivery of DSME across Thailand.   
Specific project objectives:  
1. To design a prototype of the DSME intervention  
2. To refine the intervention prototype and trial design  
3. To evaluate the effectiveness and cost effectiveness of intervention under two alternative modes of delivery 
(nurse-led and peer-led)  
2.2 RATIONALE 
3.  STUDY OBJECTIVES 

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4. To identify the most scalable model for DSME delivery in the Thai healthcare system  
  
The primary hypothesis is that either model of DSME delivery will be effective and cost-effective; however, the 
peer-led model will be a more scalable option for the Thai healthcare system.  
  
  
 
 
 
 
 
This is a four Workstream (WS) programme design based in Thailand aimed at improving cardiovascular risk 
and control of blood glucose among people with diabetes.  
WS1 and WS2: Intervention development (content and delivery model) for DSME.   
WS3 and WS4: A 3-arm cluster randomised trial in primary care units with an inbuilt process and economic 
evaluation. Twenty-one primary care units will be randomized (seven each) to provide nurse-led DSME, peer-
led DSME, or standard care. People with diabetes are the units of analysis. The trial will be unblinded.   
      4.1.1 STUDY OUTCOME MEASURES 
The study outcomes are: 
i. 
A difference in trial arms at one-year follow-up in HbA1c (co-primary outcome 1) 
ii. 
A difference in trial aims at one-year follow-up in total cardiovascular risk (co-primary outcome 2) 
 
     4.1.2 SETTING 
Primary care networks in Chiang Mai and Lampang Province in Northern Thailand, which include 21 primary 
care units.   
 
  
 
 
 
Twenty-one primary care units will be randomized (7 each) to provide nurse-led DSME, peer-led DSME, or 
standard care (1:1:1). Randomisation will be minimised by primary care networks to account for any variation 
in practice, although this is expected to be small because it is determined by the tertiary care hospital, which is 
same for both. The nurses and village health volunteers in intervention arms will be trained to deliver the 
intervention (at the community hospital or neighbourhoods as appropriate) using training films. No changes 
will be made to standard care, which currently involves a brief didactic educational session at the time of 
diagnosis of diabetes. While diabetes is diagnosed at tertiary hospitals, it is managed at, which are served by a 
full-time nurse (doctor visits weekly), and 10-15 village health volunteers linking patients in the community. 
 
 
 
 
All new referrals for diabetes management and those having difficulties managing their diabetes the first three 
years of diagnosis at the 21 primary units over a 6-month period (N=693) will be recruited to the trial, and 
offered intervention determined by the trial arm. Prospective participants will be made aware of the study 
through posters and information sheets. All new referrals will be invited to take part. Local fieldworkers will 
visit the hospitals and obtain informed consent for study participation. Once consent has been 
provided, participants will be asked to complete a short questionnaire and to give contact details.    
 
 
 
 
 
1. People aged over 18 years with a new referral for type 2 diabetes management at the 21 hospitals  
6.1 INCLUSION CRITERIA  
4.   STUDY DESIGN  
4.1 DESCRIPTION OF THE STUDY DESIGN 
5. RANDOMISATION  
6.   SELECTION AND WITHDRAWAL OF PARTICIPANTS   

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2. People aged over 18 years with difficulties managing diabetes within the first three years of diagnosis at the 
21 hospitals.   
2. Willingness to attend educational group meetings  
3. Available for six and 12-month follow-up   
  
 
 
 
1. Advanced diabetes complications such as receiving dialysis, registered blind, above ankle amputations.  
2. Co-morbid learning difficulties, dementia or current active severe mental illness 
3. Lacking the capacity to consent   
 
  
 
 
 
Written informed consent will be obtained from all study participants in a language they understand before 
any study procedures are undertaken (enrolment and follow up interviews, blood draws). Local fieldworkers 
will explain the study and patients through the patient information sheet. The right of the participant to refuse 
to participate without giving reasons will be respected.    
  
 
 
 
No major ethical issues are expected since only interventions recommended in established recent guidance 
issued will be offered. By participating in the study, participants will not be denied any form of care that is 
currently available to them, subject to local provision of services. Participants may find minor discomfort from 
the taking blood samples. Trained phlebotomists will take the blood sample. Results of Interim blood test, that 
is not part of routine care, such as HbA1c will be fed back by the study team to health care professionals only if 
there is a need for additional clinical treatment/management. The information sheet will stress the 
independence of the research team and that all data will be anonymised  
  
The Patient Information Sheet will provide potential participants with information about the possible benefits 
and anticipated risks of taking part in the study either as a participant in the main intervention or in the 
qualitative study. Participants will be given the opportunity to discuss any issues with their healthcare provider 
or researcher prior to consenting to participate. The researcher will inform the participant if new information 
comes to light that may affect the participant’s willingness to participate in the study.  
  
 
 
 
Participants have the right to withdraw from the study at any time for any reason. It is understood by all 
concerned that an excessive rate of withdrawals can render the study uninterpretable; therefore, unnecessary 
withdrawal of patients should be avoided.  Should a patient decide to withdraw from the study, all efforts will 
be made to report the reason for withdrawal as thoroughly as possible.  Should a patient withdraw from study 
intervention only, efforts to continue to obtain follow-up data will be made, with the permission of the 
patients. Patients will be asked if they are willing to be contacted by a researcher at 6 and 12 months and if not 
whether the study is able to collect ongoing data from their medical records.  
 
 
 
 
 
The intervention will consist of four Work packages (WPs):  
  
6.2 EXCLUSION CRITERIA  
6.3 CONSENT  
6.4 RISKS AND BENEFITS  
6.5 WITHDRAWAL CRITERIA  
7.  INTERVENTION 
7.1 INTERVENTION DESCRIPTION AND DELIVERY  

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WP 1:  Professional development of nurses and village health volunteer (VHVs) to educate diabetes patients 
on self-management.   
  
a. Mapping of the knowledge from a desktop reviews and focus groups from nurses and VHVs to develop a 
paper prototype of the intervention, including its hypothesised pathways of action (e.g. common-sense model 
of illness, empowerment, discovery learning, social learning, and social support) and a training manual for 
nurses and health volunteers.  
  
b. Development of 6 brief films (5-6 minutes long) to trigger discussions on key topic areas during structured 
periods of the intervention meetings, and a longer film to be used a training resource for nurses and village 
health volunteers. There is an increasing recognition that films are a highly efficient medium for 
communicating large amounts of information with a better recall, particularly in low literacy settings.20 Short 
films can be used to challenge existing beliefs to support behaviour change and create a connection within 
viewer groups to catalyse support. Films will be developed using an established theory-based process, which 
uses participatory approaches to ensure that films meet the cultural, psychological, and contextual constructs 
of the audience. Films will be in local language and use local actors.   
  
WP 2:  Piloting trial protocol and intervention of the structured diabetes self-management education 
programme for people with newly diagnosed and those with poor control of their diabetes within three 
years of diagnosis plus carers  
  
We will pilot the intervention at four community hospitals. The pilot will not be a smaller version of the trial; 
instead, several independent studies will be carried out, mainly to refine the intervention. We will also collect 
some preliminary data to check our assumptions and processes for the trial. The intervention modules will be 
tested with two nurses and village health volunteers each, who will be trained to deliver them to groups of 10-
20 persons with diabetes and their carers. Several modules will be tested in parallel, as they will be designed to 
be standalone. Data on ‘what works, doesn’t work, and what more needs to be added’ for each session will be 
collected using a) ethnographic methods, involving direct observations of the sessions, which will be video 
recorded, and unstructured and semi-structured interviews (24 in total, purposively sampled), and b) focus 
group discussions, with the nurses, village health volunteers, and group participants (8 in total). The 
intervention modules will be refined using participatory research methodology, and following an iterative 
process, including piloting, feedback, analysis, reflection, and modification, until the sessions are fit for 
purpose. We will collect quantitative data on at least 100 consecutive persons with diabetes attending the four 
community hospitals (i.e. 25 at each site), and semi-structured interviews on a subsample of ~20 people, to 
document the current care processes, collect data on distribution of outcome measures to confirm our sample 
size calculations, and pilot the trial organization and study instruments, as not all have been previously used in 
Thai populations.  
  
WP 3:  Main trial evaluation on structured DSME for people with newly diagnosed with type 2 diabetes and 
those with poor control of their type 2 diabetes within three years of diagnosis and their carers. 
The intervention will be evaluated in primary care networks in Chiang Mai and Lampang province in northern 
Thailand.  While diabetes is diagnosed at tertiary hospitals, it is managed at community hospitals and health 
centres, which are served by a full-time nurse (doctor visits weekly), and 10-15 village health volunteers linking 
patients in the community. A 3-arm cluster randomized trial with inbuilt process and economic evaluation will 
be carried out (see Annexe for trial flow diagram). The 21 primary care units will be randomized (seven each) to 
provide nurse-led DSME, peer-led DSME, or standard care. Randomisation will be minimised by primary care 
networks to account for any variation in practice, although this is expected to be small because it is determined 
by the tertiary care hospital, which is same for both. The nurses and village health volunteers in intervention 
arms will be trained to deliver the intervention (at the community hospital or neighbourhoods as appropriate) 
using training films. No changes will be made to standard care, which currently involves a brief didactic 
educational session at the time of diagnosis of diabetes. Process evaluation will aim to assess intervention 
delivery (fidelity, dose and reach), clarify causal mechanisms (those hypothesised by theory of change 
developed within the project or identify unexpected ones), and identify contextual factors (barriers, 
facilitators) associated with variation in outcomes.24 Data for economic evaluation (resource usage and quality 
of life using EQ-5D) will be obtained prospectively alongside the trial.   
  

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WP 4: Health systems analysis to identify best policy options  
Using ideas from existing literature on the subject as a basis, we will undertake targeted interviews with Thai 
policy makers to jointly define a scalability construct of relevance to them and create a framework for 
operationalising it.25 Relevant data from policy documents and available databases will be collected to 
undertake health system analyses. Key criteria for assessment of scalability are likely to include, among others: 
a) cost-effectiveness and affordability (i.e. the total cost to government of scaling up the intervention, and this 
cost in relation to total health budget, as these metrics may be of more interest to policy makers); b) 
acceptability of the intervention to users and providers, with a particular focus on integration of the new 
activity in the existing workload and health information systems; and c) compatibility of the new intervention 
with existing policy frameworks, although this will also be taken into consideration while developing the 
intervention. Our preliminary conversations with Thai policy makers suggest a strong interest in using DSME to 
improve skills of frontline workers in behavioural interventions, which could then be transported to other 
chronic disease interventions, suggesting that capacity building benefits may be an important consideration in 
policy makers’ decision.  
  
 
 
Each participant will be involved in the study for a minimum of 12 months after taking consent and baseline 
data. However, there may be a delay in contacting and scheduling participants for follow ups therefore, this 
may be slightly longer. The study is expected to start October 2018 and finish September 2021.   
  
a.  Questionnaire data will be collected by field workers via in-person interview for the full sample at baseline, 6 
and 12 months at the community hospital where they were recruited (Table 1). A custom-designed form linked 
to Microsoft Access will be used to collect, validate, verify, and store respondents’ data where possible or else 
data will be collected via paper forms and double-entered into the databases. All data files and databases will 
be password protected.   
  
b. Biological samples. Blood samples will be collected from participants at baseline, 6 and 12 months, to 
measure Blood glucose, HbA1c and lipids, coordinating where possible with the annual routine tests offered to 
patients to reduce duplication. Blood will be drawn by a trained phlebotomist when participants come for 
interview and sent to laboratory for analysis. Data will be linked to the participant information using a unique 
respondent ID, which will be assigned to all study participants.   
  
c. Interviews. During intervention development and qualitative evaluation, a subset of participants will be 
followed up using in-depth interviews and focus group discussions. These will be recorded on digital 
Dictaphones, with recordings initially stored on a personal computer or laptop in an encrypted folder with 
password protection. Recordings will be transcribed by professional transcribers conditional on signing of 
confidentiality and nondisclosure agreements.  
  
Table 1: Questionnaire-based outcome measures   
Target domain 
Questionnaire 
Adapted for 
Thailand 
Validated in 
Thailand 
Quality of life 
WHOQOL 
Yes 
Yes25 
EQ-5D  
Yes 
Yes26 
Depression  
Hospital Anxiety and Depression Scale (HADS) 
Yes 
Yes27 
 
Perceived stress questionnaire  
Yes 
Yes28 
Physical activity 
International Physical Activity Questionnaire 
Yes 
Yes29 
Diabetes 
knowledge and 
skills 
Brief diabetes illness perception questionnaire 
Yes 
Yes30 
Diabetes Self-Management Education and Support 
(DMSES) 
Yes31 
No 
Summary of Diabetes self-care activities questionnaire 
(SDSCA) 
Yes 
Yes32 
Satisfaction with 
intervention 
Chronic Illness Resources survey 
Yes 
Yes33 
  
 
 
 
8.       ASSESSMENT AND FOLLOW-UP   
8.1 LOSS TO FOLLOW UP  

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The field team shall hold weekly briefs preferably on Friday mornings with the Study Co-ordinators to generate 
a list of priority areas and lost to follow up (LTFUP) participant lists.  Arrangements to follow 
up participants who have not turned up for their appointment will be made. Participants will be sent text 
message reminders prior to their appointment. If they fail to show, then they will be contacted by phone or by 
home visit if phoning is not possible to understand the reasons and reschedule another appointment within a 
week. They will be declared lost to follow-up if they do not show for a month and are untraceable.   
  
 
 
 
The total number of participants estimated to be involved in the study is 693.   
Approximately 60 semi-structured interviews will be conducted throughout the course of the project (including 
intervention development, piloting and process evaluation), as well as 15-20 focus group discussions and 20 
ethnographic observations.  
  
 
 
This study was powered to detect a clinically important difference of 0.6 units HbA1c (SD 1.5 units) between 
the control and intervention arms. We required 693 participants from 21 hospitals (7 per arm) to achieve 80% 
power at 2.5% significance level (to account for multiple testing), assuming an ICC between hospitals of 0.02 
and loss to follow-up rate of 20%.22,23   
 
 
 
 
Data will be collected from approximately 693 individuals newly diagnosed with diabetes, across 21 primary 
care units in the Chiang Mai and Lampang province of Thailand.  
  
The following data will be collected at baseline, 6 months and 12 months:  
a. Questionnaire and body measurement data will be collected in person and entered where possible directly 
into a password-protected Microsoft Access database (via a form) on laptops, or else using double-entered 
paper forms.   
b. Blood samples will be labelled and sent for analysis at the local hospital lab, and once analysed the results 
will be merged back into the main database. Once fully entered and validated, data will be transferred to 
comma separated value (csv) files for more efficient long-term storage and sharing  
c. Qualitative data will be collected via interview and direct observation, and initially stored as voice and video 
recordings, later transcribed and data extracted using NVivo software.   
 
 
 
 
A data collection protocol will be developed, and the project coordinator in Thailand will provide training to 
fieldworkers before data collection commences. Validation will be performed on a Data Management on 
a random sample of questionnaire data by cross-checking with clinic records. Any discrepancies will be 
followed-up and addressed by field workers, re-contacting participants to clarify as necessary. Quantitative 
data will be entered directly via a form with built in data checks to minimise transcription errors (or where 
necessary collected on paper and later double-entered into the electronic form). Post entry checks will be 
conducted using statistical software. Blood samples will be collected by trained phlebotomists 
in NaF vacutainers for blood glucose estimation; stored in ice slurry and centrifuged and separated after 30 
minutes of collection to prevent glycolysis, and the plasma will be dispensed to the lab for analysis. All hospital 
laboratories have their own internal quality assurance protocols and are also linked to a national external 
quality assurance mechanism. Fieldworkers will be trained in qualitative methods and an interview schedule 
will be devised. Project coordinators will spot-check interview transcripts to ensure quality.  
  
 
 
9.   STATISTICS AND DATA ANALYSIS 
9.1. SAMPLE SIZE CALCULATION  
9.2. FORMAT AND SCALE OF THE DATA  
10.
DATA QUALITY AND STANDARDS
10.1. DATA MANAGEMENT  

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Data will be uploaded to a secure server at Chiang Mai University as soon as possible. Copies of data with 
numerical study identifiers replacing other identifying information will be transferred to LSHTM for analysis 
using a secure encrypted data transfer service (MyFiles, previously Filr). Interviews will be recorded on digital 
Dictaphones and immediately transferred to a secure local server at CMU on completion. Following 
transcription, data will be transferred to LSHTM as above. Audio recordings will be kept until transcription has 
been completed and verified, after which they will be deleted. LSHTM data systems are maintained in 
accordance with LSHTM’s Information Management & Security Policy, backed-up and virus scanned on a daily 
basis. All staff involved in research will be trained in the study procedures and data management before the 
study commences.  
  
 
 
 
     10.2.1 QUANTITATIVE ANALYSIS 
Available outcome data will be analysed on an intention to treat basis. Potential clustering of outcomes at the 
level of community hospitals will be accounted for using mixed-effects models. Adjustment for baseline 
imbalances in outcomes or relevant covariates will be considered as appropriate. Effects of variations in 
intervention uptake and other relevant effect modifiers will be explored.   
 
     10.2.2 QUALITATIVE ANALYSIS 
Qualitative data will be transcribed and analysed in NVivo, using both descriptive (e.g. understanding their 
experiences) and interpretive (e.g. interpreting them in cultural context) phenomenology approaches. 
Comparative analysis will also be carried out; this method allows data from different participants to 
be compared and contrasted. Deviant cases will be actively sought throughout the analysis and emerging ideas 
and themes modified in response.   
  
 
 
 
Data and all appropriate documentation will be stored for a minimum of 10 years after the completion of the 
study, including the follow-up period.    
  
 
 
 
Both UK and Thai PIs are jointly responsible for data produced in this study and assurance of its quality. The 
LSHTM-based research fellow and Thailand-based research assistant will conduct data collection, management, 
curation, security and sharing during the lifetime of the grant.   
  
The Chief Investigator will inform the sponsor should they have concerns, which have arisen from monitoring 
activities, and/or if there are problems with oversight/monitoring procedures.  
 
  
  
 
 
 
 
 
This study is to be conducted according to the international standards of Good Clinical Practice (GCP) 
(International Conference on Harmonization guidelines), Declaration of Helsinki, and International Ethical 
Guidelines for Biomedical Research Involving Human Subjects, applicable national government regulations, and 
Institutional research policies and procedures. All investigators will receive GCP training to the onset of the 
study. Ethical approvals will be sought prior to commencement of the project from Thailand’s Central Research 
10.2. DATA ANALYSIS  
10.3. DATA STORAGE 
10.4. MONITORING  
11.  REGULATORY ISSUES   
11.1 ETHICS APPROVAL  

DSME Thailand study  Page 15 of 19                              Version 2.0 08.02.2019 
Ethics Committee and the London School of Hygiene & Tropical Medicine. The study protocol, informed 
consent form, participant’s information sheet and other relevant information has been submitted to and 
approved by Chiang Mai University and local Ethics Committee. Any future amendments of the protocol shall 
be submitted to and approved by the Intuition Review Board (IRB) before implementation   
 
 
 
 
As this is a cluster-randomised study, consent to randomisation is obtained at the cluster (hospital) level. 
Informed consent will be obtained for procedures that are specifically for the purposes of the study, i.e. data 
collection and blood tests for adults newly diagnosed with diabetes and for those with poor control within 
three years after diagnosis. Consent to enter the study must be sought from each participant only after a full 
explanation has been given, an information leaflet offered, and time allowed for consideration. The PI is 
responsible for ensuring that all vulnerable participants are protected and participate voluntarily in an 
environment free from coercion or undue influence.  All information sheets and consent forms will be available 
in English and Thai and will be verified for accuracy through back-translation. Consent discussions will be 
conducted in the appropriate language and a translator will be used if necessary.  
  
 
 
 
Any participants’ identifiable data collected by the Study Coordination Centre will be stored securely and their 
confidentiality protected in accordance with the Data Protection Act 1998.  
To protect against the possibility that personally identifiable information will be accessed and used by 
unauthorised individuals, several security measures will be applied. Data collection devices (laptops/tablets) 
will be password protected. Access to electronic data on servers located at CMU and LSHTM will be protected 
using access controls including password protection; access will only be available to research personnel 
through the authorization of the PIs. An audit trail will record activity on the main Access databases. All staff 
will be trained in handling of personally identifiable data. Qualitative and quantitative data will be anonymised 
at the earliest opportunity. Qualitative data will be used to inform intervention development and the process 
evaluation only; generic identifiers (e.g. participant 1) will be used from the transcription stage onwards. The 
key linking participants’ names with study IDs will be stored separately from other data in a double-locked file 
at the secure project office, with access restricted to appropriate study personnel. Paper consent forms will be 
stored similarly. Study reports, such as aggregated data in progress reports, will not contain identifying 
information. Project office computers will be safeguarded from theft and damage (e.g. using locks, encryption, 
and antivirus software). Fully anonymised data may be transferred for analysis to co-investigators at LSHTM 
and other academic and commercial partners. A secure encrypted data transfer service will be used. Upon 
request, participant records will be made available to the study sponsor.   
 
 
 
  
London School of Hygiene & Tropical Medicine holds Public Liability ("negligent harm") and Clinical Trial ("non-
negligent harm") insurance policies, which apply to this trial.  
 
  
 
 
 
London School of Hygiene & Tropical Medicine will act as the main sponsor for this study.  Delegated 
responsibilities will be assigned locally.    
 
 
  
 
The UK Medical Research Council and The Thailand Research Fund are funding this study.    
11.2 CONSENT  
11.3 CONFIDENTIALITY  
11.4 INDEMNITY 
11.5 SPONSER  
11.6. FUNDING  

DSME Thailand study  Page 16 of 19                              Version 2.0 08.02.2019 
  
 
 
 
The study may be subject to audit by the London School of Hygiene & Tropical Medicine under their remit as 
sponsor, the Study Coordination Centre and other regulatory bodies to ensure adherence to GCP.   
  
 
 
 
 
 
 
 
The TMG will be responsible for overseeing the progress of the trial, and will meet monthly by Skype, and once 
each year in person, using opportunities afforded by existing collaborations and cross-appointments. Safety 
and adverse events will be reviewed at TMG meetings, and any concerns will be reported to the Trial Steering 
Committee (TSC), and their advice followed. The TMG will also formulate key policies and working groups (e.g. 
communication, data management, publication).  
  
A Trial Management Group (TMG) will be formed, consisting of the following:   
• 
Chief investigator  
• 
Local Principal Investigators  
• 
Other co-investigators  
• 
Local project managers  
• 
Local trial administrators  
  
 
 
 
The role of the Trial Steering Committee (TSC) is to provide overall supervision of the trial. The TSC will meet bi-
monthly for the first year then every six months after that. The TSC will take responsibility for the following:  
• 
Monitoring and supervision of the trial  
• 
Review progress towards the study milestones  
• 
Amending the protocol if needed  
• 
Approve any additional trial sites  
• 
Confirm all approvals are in place before the start of recruitment  
• 
Advise the TMG on any safety concerns  
• 
Oversee publication of trial results  
  
The TSC will include experts in the field of DSME, health psychology and clinical trials, and will have an 
independent Chair. In addition, there will be patient and carer representatives as well as policy 
representation. [Membership to be confirmed]  
 
 
 
 
 
A formal Data Monitoring Safety Board will not be convened, as there are minimal risks from this educational 
intervention and related data collection. If any adverse events are apparent then this will reviewed and 
addressed through the regular TMG meetings and in consultation with local site guidelines.    
  
 
 
 
11.7. AUDITS AND INSPECTIONS  
12. TRIAL MANAGEMENT  
12.1      TRIAL MANAGEMENT GROUP   
12.2     TRIAL MANAGEMENT COMMITTEE 
12.3 DATA MONITORING AND SAFETY OVERSIGHT  
12.4 LOCAL MANAGEMENT   

DSME Thailand study  Page 17 of 19                              Version 2.0 08.02.2019 
Day-to-day management of the trial will be co-ordinated through the local Study Coordination Centre in 
Thailand.  
 
Study coordinating centre  
MRC and LSHTM Thailand Research Unit  
Study coordinator  
Kanokporn Pinyopornpanish 
Local PI  
Chairisi Angkurawaranon  
  
Responsibilities of the local Principal Investigator will be detailed in an agreement in advance of starting the trial 
and will include:  
• 
Ensure all necessary approvals are in place prior to starting the trial  
• 
Delegate trial related responsibilities only to suitably trained and qualified personnel  
• 
Agree to comply with the final trial protocol and any relevant amendments  
• 
Ensure consent is obtained in line with local approved procedures  
• 
Allow access to source data for monitoring, audit and inspection  
• 
Be responsible for archiving all original trial documents including consent forms   
 
 
 
  
A dissemination strategy will be produced at the outset by the study management group to ensure that the 
project and its findings are widely disseminated through a range of stakeholder meetings, the internet, and 
social media. Expected output and impact Research findings will be disseminated to scientific audiences at 
major conferences (at least two) and published in high-impact open-access scientific journals; planned 
publications include those on trial protocol, intervention development, primary trial results, and process 
evaluation, and health systems analysis, at a minimum. This study is expected to have a major policy impact 
due to the close involvement of a key policy maker in the project (Co-I Srivanichakorn). Towards the end of the 
study a dedicated workshop will be held with key governmental stakeholders to disseminate the recommended 
model for DSME implementation in Thailand and encourage inclusion of a large-scale scientific evaluation into 
any national implementation of the scheme.  
  
 
 
 
Any conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect of 
this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest will be 
required to have such conflicts managed in a way that is appropriate to their participation in the trial. The study 
leadership has established policies and procedures for all study group members to disclose all conflicts of 
interest and will establish a mechanism for the management of all reported dualities of interest. 
 
 
 
 
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14. CONFLICT OF INTEREST POLICY

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