Diabetes Self Management Education Programme in Thailand
DSMET
A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand
1 other identifier
interventional
693
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2020
Longer than P75 for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedJanuary 18, 2020
February 1, 2019
2.5 years
April 24, 2019
January 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hemoglobin A1c levels (HbA1c)
HbA1c will measures the average blood glucose (sugar) levels months
12 months
Total cardiovascular risk
The cardiovascular risk will be estimated by Systemic Coronary Risk Evaluation. (SCORE) model. This is a range from 120 to 180 measuring systolic blood pressure (mmHq).
12 months
Secondary Outcomes (6)
EQ-5D
12 months
Hospital Anxiety and Depression scale (HADS)
12 months
Perceived Stress Questionnaire (PSQ)
12 months
Summary of Diabetes Self-Care Activities Assessment (SDSCA)
12 months
International Physical Activity Questionnaire
12 months
- +1 more secondary outcomes
Other Outcomes (1)
Smoking
12 months
Study Arms (3)
DSME program delivered by community health volunteers
ACTIVE COMPARATORRandomisation will happen in 21 primary care units to offer DSME delivered by lay health workers to those newly diagnosed with diabetes and those having difficulties with self-managing their diabetes.
DSME program delivered by nurses
ACTIVE COMPARATORRandomisation will happen in 21 primary care units to offer DSME delivered by nurses (for comparative effectiveness) to those newly diagnosed with diabetes and those having difficulties with self-managing their diabetes.
Usual care(no DSME program)
NO INTERVENTIONRandomisation will happen in 21 primary care units where no DSME will be offered to those newly diagnosed with diabetes and/or those having difficulties with self-managing their diabetes.These patients will continue with usual care and will be assessed as the control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Medical Research Councilcollaborator
- Chiang Mai Universitycollaborator
Related Publications (2)
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.
PMID: 34887283DERIVEDAngkurawaranon 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.
PMID: 33020090DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Kinra, MD, PhD
London School of Hygiene and Tropical Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2019
First Posted
May 6, 2019
Study Start
March 1, 2020
Primary Completion
September 1, 2022
Study Completion
March 1, 2023
Last Updated
January 18, 2020
Record last verified: 2019-02