Scaling Up NCD Interventions in South East Asia

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Hypertension; Diabetes Mellitus, Type 2
• Interventions: Combination Product: screening, prevention and counselling

• Registration Number: NCT05239572
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Study Start: 2022-03-31
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16850

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening and early detection of diabetes and cardiovascular diseases	screening, prevention and counselling	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Health Strategy and Policy Institute; 🇻🇳 Hanoi, Vietnam