Clinical trial NCT05239572: Scaling Up NCD Interventions in South East Asia
Official title: Scaling Up Non-Communicable Diseases Interventions in South East Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Keywords: prevention
early diagnosis
lifestyle intervention
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Groningen
name: University of Passau
name: Universitas Sebelas Maret
name: Health Strategy and Policy Institute
name: Trnavska Universita v Trnava
name: HelpAge International
name: Thai Nguyễn University of Medicine and Pharmacy
First posted: 2022-02-15
Enrollment: 16850
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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)
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Uptake of NCD screening offered in communities
timeFrame: 18 months from offering screening options in communities until measuring uptake
measure: Adherence to follow-up advice
timeFrame: 12 months from counselling and advice to individual until measuring adherence to follow-up that has been recommended
measure: Uptake of health education (health promotion, awareness of risk factors)
timeFrame: 12 year between first health education session and measuring uptake (based on participants' lists)
Secondary outcomes:
measure: Unit costs of screening, prevention and early diagnosis of NCDs per Quality Adjusted Life Year gained
timeFrame: 18 months between starting calculation of costs of interventions and assessment of final assessment of benefits
measure: Cost-effectiveness of NCD interventions
timeFrame: 18 months between baseline survey and endline survey
Other outcomes:
measure: Impact of training of community health volunteers in NCD interventions on knowledge attitudes and practices of volunteers
timeFrame: 6 months between provision of training to community health volunteers and measuring their skills, knowledge and attitudes
measure: Impact of training of community health volunteers on their performance in NCD interventions.
timeFrame: 6 months between provision of training to community health volunteers and measuring their performance
Locations:
city: Hanoi
country: Vietnam
facility: Health Strategy and Policy Institute
Study officials:
affiliation: University Medical Center Groningen
name: Maarten Postma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Groningen
name: Robert Lensink, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Sebelas Maret
name: Ari Probandari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Strategy and Policy Institute
name: Giang Nguyen Hoang, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: HelpAge International
name: Anil Kumar Indira Krishna, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Passau
name: Michael Grimm, PhD
role: PRINCIPAL_INVESTIGATOR
References: