Clinical trial NCT03938233: Diabetes Self Management Education Programme in Thailand
Official title: A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Self-management
Structured Education
Thailand
Peer Led
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Chiang Mai University
First posted: 2019-05-06
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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, a low-cost DSME program will be developed with a scalable delivery model for roll-out within the Thai primary care system. The intervention will be based on behaviour-change and social support theories, 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. 21 primary care units will be randomised to offer to those with diabetes diagnosed within the first three years. DSME will be delivered by lay health workers, nurses (for comparative effectiveness), or usual care. After 12 months, glycaemic control and cardiovascular risk scores will be compared between the three arms. Cost-effectiveness will be assessed, also process and policy evaluations to produce best-buy recommendations for the Thai Ministry of Public Health.

Detailed description: The health and economic consequences of Type 2 diabetes mellitus are largely attributable to its complications, which can be prevented or delayed by good disease control, 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. The aim is 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. A final list of policy recommendations for optimal integration into the Thai healthcare system will be produced.

The aim is to identify a scalable model for delivery of DSME across Thailand.

Specific project objectives are:

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 the intervention under two alternative modes of delivery (nurse-led and peer-led)
4. To identify the 'best buy' model for scale-up of DSME delivery in the Thai health system.

The primary hypothesis is that either model of DSME delivery will be effective and cost-effective, but the peer-led model will be a more scalable option for the Thai health system.

The two key research gaps in scientific literature that will be addressed are:

1. Clinical and cost-effectiveness of DSME programs in low- and middle-income countries, specifically Thailand
2. Role of peer programs in supporting complex behaviour change generally, and its implementation in low- and middle-income settings specifically.

The main expected outcomes are:

1. Development of a fully worked-up rapidly scalable model for DSME delivery in Thailand;
2. Capacity building of emerging Thai researchers and practitioners (nurses, village health volunteers) in the science and delivery of complex behavioural interventions, which could be expanded to other chronic conditions;
3. Long-term collaborative research links between UK and Thai researchers.

Eligibility criteria: Inclusion Criteria:

* People aged over 18 years with a new referral for type-2 diabetes management at the 15 hospitals
* People aged over 18 years with difficulties managing type-2 diabetes up to three years of diagnosis at the 15 hospitals
* Willingness to attend educational group meetings
* Available for 12-month follow-up

Exclusion Criteria:

* Advanced diabetes complications such as receiving dialysis, registered blind, above ankle amputations.
* Co-morbid learning difficulties, dementia or severe mental illness
* Lacking the capacity to consent
* Those aged under 18 years.

Primary outcomes:
measure: Hemoglobin A1c levels (HbA1c)
timeFrame: 12 months
measure: Total cardiovascular risk
timeFrame: 12 months
Secondary outcomes:
measure: EQ-5D
timeFrame: 12 months
measure: Hospital Anxiety and Depression scale (HADS)
timeFrame: 12 months
measure: Perceived Stress Questionnaire (PSQ)
timeFrame: 12 months
measure: Summary of Diabetes Self-Care Activities Assessment (SDSCA)
timeFrame: 12 months
measure: International Physical Activity Questionnaire
timeFrame: 12 months
measure: Body mass index (BMI)
timeFrame: 12 months
Other outcomes:
measure: Smoking
timeFrame: 12 months
Locations:
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Sanjay Kinra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papachristou Nadal I, Aramrat C, Jiraporncharoen W, Pinyopornpanish K, Wiwatkunupakarn N, Quansri O, Rerkasem K, Srivanichakorn S, Techakehakij W, Wichit N, Pateekhum C, Birk N, Ngetich E, Khunti K, Hanson K, Kinra S, Angkurawaranon C. Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T). BMJ Open. 2021 Dec 9;11(12):e056141. doi: 10.1136/bmjopen-2021-056141.
citation: Angkurawaranon C, Papachristou Nadal I, Mallinson PAC, Pinyopornpanish K, Quansri O, Rerkasem K, Srivanichakorn S, Techakehakij W, Wichit N, Pateekhum C, Hashmi AH, Hanson K, Khunti K, Kinra S. Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol. BMJ Open. 2020 Oct 5;10(10):e036963. doi: 10.1136/bmjopen-2020-036963.