Scaling Up NCD Interventions in South East Asia

NCT05239572 | Completed

• 1 other identifier: 202100908
• Study Type: interventional
• Target: 16,850
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases

Keywords

prevention; early diagnosis; lifestyle intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

• Cost-effectiveness of NCD interventions

  18 months between baseline survey and endline survey

Other Outcomes (2)

• Impact of training of community health volunteers in NCD interventions on knowledge attitudes and practices of volunteers

  6 months between provision of training to community health volunteers and measuring their skills, knowledge and attitudes

• Impact of training of community health volunteers on their performance in NCD interventions.

  6 months between provision of training to community health volunteers and measuring their performance

Study Arms (1)

Screening and early detection of diabetes and cardiovascular diseases

EXPERIMENTAL

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

Interventions

screening, prevention and counselling COMBINATION_PRODUCT

Screening in Intergenerational solidarity clubs in Myanmar and Vietnam and in Posbindu programme in Indonesia

Also known as: lifestyle coaching for persons with risk factors for NCDs, referral to primary healthcare facilities for further diagnosis and treatment, simple treatment of NCDs at primary healthcare level, Online monitoring and counselling for risk factors for NCDs

Screening and early detection of diabetes and cardiovascular diseases

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults living in geographical area where research takes place

You may not qualify if:

• Persons who are not able to come to location of screening, due to illness or other chronic condition causing immobility.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• University of Groningen: collaborator
• University of Passau: collaborator
• Universitas Sebelas Maret: collaborator
• Health Strategy and Policy Institute: collaborator
• Trnavska Universita v Trnava: collaborator
• HelpAge International: collaborator
• Thai Nguyễn University of Medicine and Pharmacy: collaborator

Study Sites (1)

Health Strategy and Policy Institute

Hanoi, Vietnam

Location

Related Publications (2)

• Hanifa RS, Rokhman MR, Fritz M, Widyaningsih V, Febrinasari RP, Koot JAR, Postma MJ, van der Schans J. Cost-effectiveness of community-based type 2 diabetes prevention and control in Indonesia: a health economics modelling study. BMJ Public Health. 2025 Oct 7;3(2):e002161. doi: 10.1136/bmjph-2024-002161. eCollection 2025.

  PMID: 41069974 DERIVED

• Fritz M, Grimm M, My Hanh HT, Koot JAR, Nguyen GH, Nguyen TP, Probandari A, Widyaningsih V, Lensink R. Effectiveness of community-based diabetes and hypertension prevention and management programmes in Indonesia and Viet Nam: a quasi-experimental study. BMJ Glob Health. 2024 May 22;9(5):e015053. doi: 10.1136/bmjgh-2024-015053.

  PMID: 38777393 DERIVED

Related Links

• dedicated research project website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases; Disease

Interventions

Mass Screening; Counseling; Risk Factors; Therapeutics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Risk; Probability; Statistics as Topic; Causality; Epidemiologic Factors

Study Officials

• Maarten Postma, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Robert Lensink, PhD

  University of Groningen

  PRINCIPAL INVESTIGATOR

• Ari Probandari, PhD

  University Sebelas Maret

  PRINCIPAL INVESTIGATOR

• Giang Nguyen Hoang, MPH

  Health Strategy and Policy Institute

  PRINCIPAL INVESTIGATOR

• Anil Kumar Indira Krishna, PhD

  HelpAge International

  PRINCIPAL INVESTIGATOR

• Michael Grimm, PhD

  University of Passau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 15, 2022
• Study Start: March 31, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available after July 2023 and will be available for period according to regulations of European Union
• Access Criteria: On request for researchers performing secondary data analysis

Locations

VN (1)