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NCT Number: NCT05239572

Scaling Up NCD 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Disease Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Strategy and Policy Institute

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

screening, prevention and counselling

Combination Product

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

Primary outcomes

  1. 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

  2. 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)

  3. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

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

Registry information

Official study title

Scaling Up Non-Communicable Diseases Interventions in South East Asia

Acronym: SUNI-SEA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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