Diabetes Mellitus, Type 2DSMETNCT03938233
Diabetes Self Management Education Programme in Thailand
A study testing A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system in people with Diabetes Mellitus, Type 2, run by London School of Hygiene and Tropical Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 693 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Iliatha Papachristou Nadal, PhD, Psychol contact
Chaisiri Angkurawaranon, MD, PhD contact
About this study
Official title: A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand
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.
Read the 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:
- To design a prototype of the DSME intervention
- To refine the intervention prototype and trial design
- To evaluate the effectiveness and cost-effectiveness of the intervention under two alternative modes of delivery (nurse-led and peer-led)
- 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:
- Clinical and cost-effectiveness of DSME programs in low- and middle-income countries, specifically Thailand
- 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:
- Development of a fully worked-up rapidly scalable model for DSME delivery in Thailand;
- 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;
- Long-term collaborative research links between UK and Thai researchers.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system
- Keywords
- Diabetes, Self-management, Structured Education, Thailand, Peer Led
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care systemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DSME program delivered by community health volunteers | Active comparator | Randomisation 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. Receives: Behavioral: A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system |
| DSME program delivered by nurses | Active comparator | Randomisation 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. Receives: Behavioral: A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system |
| Usual care(no DSME program) | No intervention | Randomisation 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c levels (HbA1c)
HbA1c will measures the average blood glucose (sugar) levels months
Measured: 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).
Measured: 12 months
Secondary outcomes (6)
EQ-5D
Quality of Life measure that will also assess cost-effectiveness. Includes five quality of life question on mobility, self-care, usual activity, pain, anxiety / depression and a scale of 0 to 100 on how the person is feeling on that day.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.
Measured: 12 months
Hospital Anxiety and Depression scale (HADS)
HADS measures depression and anxiety which will address psychological change. Scale is from 0 to 3.
Scale defined as:
Definitely 0 Usually 1 Sometimes 2 Not often 3 Not at all Total score of 21.
Scoring:
Total score:
0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Measured: 12 months
Perceived Stress Questionnaire (PSQ)
PSQ will assess stress and ability to self-management. 30 questions on how the person is feeling with a scale from 1 to 4.
0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: 12 months
Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Diabetes self-care activities questionnaire focuses on general diet, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. With a scale of 0 to 7 with no cut of points. Higher score indicate higher self care activities.
Measured: 12 months
International Physical Activity Questionnaire
The assessment of physical activity comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions.There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Expressed as MET-min per week:
MET level x minutes of activity x events per week
Sample Calculation:
MET levels MET-min/week for 30 min episodes, 5 times/week Walking = 3.3 METs 3.3*30*5 = 495 MET-min/week Moderate Intensity = 4.0 METs 4.0*30*5 = 600 MET-min/week Vigorous Intensity = 8.0 METs 8.0*30*5 = 1,200 MET-min/week
___________________________ TOTAL = 2,295 MET-min/week Total MET-min/week = (Walk METs*min*days) + (Mod METs*min*days) + Vig METs*min*days)
Measured: 12 months
Body mass index (BMI)
Height and weight (used to derive BMI)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 693 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Chiang Mai University
- Responsible party
- Sponsor
- Investigators
- Sanjay Kinra, MD, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938233
- Sponsor's protocol ID
- 1
- Acronym
- DSMET
- Status last verified
- Feb 2019
- First submitted
- 24 Apr 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made upon reasonable request
Publications
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.
PubMed 34887283Angkurawaranon 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.
PubMed 33020090
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand
- ClinicalTrials.gov ID
- NCT03938233
- Acronym / sponsor ID
- DSMET / 1
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Self-management, Structured Education, Thailand, Peer Led
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 693 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council, Chiang Mai University
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To design a prototype of the DSME intervention
- To refine the intervention prototype and trial design
- To evaluate the effectiveness and cost-effectiveness of the intervention under two alternative modes of delivery (nurse-led and peer-led)
- 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:
- Clinical and cost-effectiveness of DSME programs in low- and middle-income countries, specifically Thailand
- 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:
- Development of a fully worked-up rapidly scalable model for DSME delivery in Thailand;
- 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;
- Long-term collaborative research links between UK and Thai researchers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cluster randomised control trial
| Arm | Type | Receives |
|---|---|---|
| DSME program delivered by community health volunteers | Active comparator | Behavioral: A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care systemRandomisation 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 comparator | Behavioral: A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care systemRandomisation 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 intervention | –Randomisation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care systemThe 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. | Behavioural | DSME program delivered by community health volunteers, DSME program delivered by nurses |
Primary outcome
Hemoglobin A1c levels (HbA1c)
Time frame: 12 months
HbA1c will measures the average blood glucose (sugar) levels months
Total cardiovascular risk
Time frame: 12 months
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).
6 secondary outcomes
EQ-5D
Time frame: 12 months
Hospital Anxiety and Depression scale (HADS)
Time frame: 12 months
Perceived Stress Questionnaire (PSQ)
Time frame: 12 months
Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Time frame: 12 months
International Physical Activity Questionnaire
Time frame: 12 months
Body mass index (BMI)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 34887283Papachristou 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.
- Derived from this study: PubMed 33020090Angkurawaranon 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.
- Individual participant dataSharing planned: Undecided. Data will be made upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iliatha Papachristou Nadal, PhD, Psychol contact
Chaisiri Angkurawaranon, MD, PhD contact
Sanjay Kinra, MD, PhD principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
A study testing A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system in people with Diabetes Mellitus, Type 2, run by London School of Hygiene and Tropical Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iliatha Papachristou Nadal, PhD, Psychol (020 7927 2198 ext. 2198, iliatha.papachristounadal@lshmt.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c levels (HbA1c) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938233, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.