Scaling Up NCD Interventions in South East Asia

Hypertension Clinical Trial

— SUNI-SEA  

Official title:

Scaling Up Non-Communicable Diseases Interventions in South East Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239572
• Other study ID #: 202100908
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16850
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Combination Product:
• screening, prevention and counselling
Screening in Intergenerational solidarity clubs in Myanmar and Vietnam and in Posbindu programme in Indonesia

Locations

Country	Name	City	State
Vietnam	Health Strategy and Policy Institute	Hanoi

Sponsors (8)

Lead Sponsor	Collaborator
University Medical Center Groningen	Health Strategy and Policy Institute, HelpAge International, Thai Nguy?n University of Medicine and Pharmacy, Trnavska Universita v Trnava, Universitas Sebelas Maret, University of Groningen, University of Passau

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6 months between provision of training to community health volunteers and measuring their skills, knowledge and attitudes
Other	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.	6 months between provision of training to community health volunteers and measuring their performance
Primary	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
Primary	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
Primary	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	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	18 months between starting calculation of costs of interventions and assessment of final assessment of benefits
Secondary	Cost-effectiveness of NCD interventions	Comparison of costs and effects between intervention and business as usual, using diff in diff method	18 months between baseline survey and endline survey

External Links

•   dedicated research project website