An interventional study of screening, prevention and counselling in Diabetes Mellitus, Type 2, Hypertension and Cardiovascular Diseases, sponsored by University Medical Center Groningen. Completed at 1 site in Vietnam. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Screening
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 16,850 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Uptake of NCD screening offered in communities
Number of adults eligible for NCD screening in communities who participate in screening
Time frame: 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)
Time frame: 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
Time frame: 12 year between first health education session and measuring uptake (based on participants' lists)
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
Time frame: 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
Time frame: 18 months between baseline survey and endline survey
Impact of training of community health volunteers in NCD interventions on knowledge attitudes and practices of volunteers
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.
Time frame: 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.
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.
Time frame: 6 months between provision of training to community health volunteers and measuring their performance
Plan to share: Yes — 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
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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