Scaling Up NCD Interventions in South East Asia (SUNI-SEA)

October 26, 2023 updated by: University Medical Center Groningen

Scaling Up Non-Communicable Diseases Interventions in South East Asia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Health Strategy and Policy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening and early detection of diabetes and cardiovascular diseases

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
Screening in Intergenerational solidarity clubs in Myanmar and Vietnam and in Posbindu programme in Indonesia
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of NCD screening offered in communities
Time Frame: 18 months from offering screening options in communities until measuring uptake
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
Time Frame: 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)
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)
Time Frame: 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
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
Time Frame: 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
18 months between starting calculation of costs of interventions and assessment of final assessment of benefits
Cost-effectiveness of NCD interventions
Time Frame: 18 months between baseline survey and endline survey
Comparison of costs and effects between intervention and business as usual, using diff in diff method
18 months between baseline survey and endline survey

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of training of community health volunteers in NCD interventions on knowledge attitudes and practices of volunteers
Time Frame: 6 months between provision of training to community health volunteers and measuring their skills, knowledge and attitudes
Difference in knowledge, attitudes and practices (KAP) of volunteers in ISHCs in Myanmar and Vietnam, and cadres in Posbindu in Indonesia as result of training offered in the research project, measured by pre- and post-training KAP survey and six months after training.
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.
Time Frame: 6 months between provision of training to community health volunteers and measuring their performance
Performance of community health volunteers six months after training, measured by observational study, with measuring adherence to standard operating procedures for screening for NCDs and health education.
6 months between provision of training to community health volunteers and measuring their performance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

University of Groningen
Universitas Sebelas Maret
University of Passau
Health Strategy and Policy Institute
Trnavska Universita v Trnava
HelpAge International
Thai Nguyễn University of Medicine and Pharmacy

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202100908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Following open research guidelines of European Union data will be shared about screening, follow-up and referral. Data collected in cos-effectiveness analysis will be shared

IPD Sharing Time Frame

Data will become available after July 2023 and will be available for period according to regulations of European Union

IPD Sharing Access Criteria

On request for researchers performing secondary data analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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