Scaling Up NCD Interventions in South East Asia

Study Overview
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Brief Summary
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The SUNI-SEA study is an intervention study that measures effectiveness and cost-effectiveness of prevention and early diagnosis of diabetes and cardiovascular diseases in communities and primary healthcare (PHC) facilities in Indonesia, Myanmar and Vietnam.

Detailed Description
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The study takes place in Vietnam and Indonesia in Intergenerational Self-Help Clubs (ISHGs), where community members assemble for activities concerning social, economical improvement and health and well-being. Volunteers in these ISHGs are trained in performing screening for diabetes and cardiovascular diseases and counselling participants concerning healthy living, or referral to primary healthcare facilities, if needed. At PHC level further diagnosis and if needed treatment is provided and referral back to ISHGs is done for lifestyle interventions. In Indonesia screening takes place in the Posbindu programme, where trained volunteers (cadres) screen and counsel participants. If needed referral to Puskesmas (primary healthcare facilities is done, where further diagnosis and treatment takes place. Activities for health promotion and lifestyle interventions take place under supervision of the Posbindu programme. In Myanmar and Indonesia individual monitoring and health education of participants is done through mobile applications. Measuring of uptake, follow-up and adherence to interventions is done through routine data collection, through surveys, and through semi-structured interviews and focus group discussions.

Official Title
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Scaling Up Non-Communicable Diseases Interventions in South East Asia

Conditions
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Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases

Intervention / Treatment
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* Combination Product: screening, prevention and counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults living in geographical area where research takes place Exclusion Criteria: Persons who are not able to come to location of screening, due to illness or other chronic condition causing immobility.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: In Vietnam members from 60 Intergenerational Self Help Clubs have been screened for diabetes and cardiovascular diseases. (total 5,000 persons) In Myanmar members from 15 Intergenerational Solidarity Groups have undergone screening for diabetes and cardiovascular diseases using an internet application. (total 1850 persons) In Indonesia, visitors of 20 Posbindu programmes were offered screened for diabetes and hypertension in Central and East Java (10,000 persons)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening and early detection of diabetes and cardiovascular diseases<br>Screening for NCDs based on questionnaire concerning vital information, lifestyle, simple measures of length, bodyweight, BMI, blood pressure, application of FinRisk score and WHO risk score. Health promotion and lifestyle counselling and referral to PHC facilities for further diagnosis and treatment. | Combination Product: screening, prevention and counselling<br>* Screening in Intergenerational solidarity clubs in Myanmar and Vietnam and in Posbindu programme in Indonesia<br>* Other names: Online monitoring and counselling for risk factors for NCDs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of NCD screening offered in communities | Number of adults eligible for NCD screening in communities who participate in screening | 18 months from offering screening options in communities until measuring uptake | 
| Adherence to follow-up advice | Percentage of participants in screening who follow up on recommendations given during screening (referral, lifestyle change) | 12 months from counselling and advice to individual until measuring adherence to follow-up that has been recommended | 
| Uptake of health education (health promotion, awareness of risk factors) | Percentage of adults above 21 years in communities participating in one or more health education sessions offered | 12 year between first health education session and measuring uptake (based on participants' lists) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unit costs of screening, prevention and early diagnosis of NCDs per Quality Adjusted Life Year gained | Unit costs of NCD screening, prevention, early diagnosis intervention per Quality Adjusted Life Year gained | 18 months between starting calculation of costs of interventions and assessment of final assessment of benefits | 
| Cost-effectiveness of NCD interventions | Comparison of costs and effects between intervention and business as usual, using diff in diff method | 18 months between baseline survey and endline survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, early diagnosis, lifestyle intervention