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

Primary Purpose

Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
screening, prevention and counselling
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetes Mellitus, Type 2 focused on measuring prevention, early diagnosis, lifestyle intervention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health Strategy and Policy InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening and early detection of diabetes and cardiovascular diseases

Arm Description

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.

Outcomes

Primary Outcome Measures

Uptake of NCD screening offered in communities
Number of adults eligible for NCD screening in communities who participate in screening
Adherence to follow-up advice
Percentage of participants in screening who follow up on recommendations given during screening (referral, lifestyle change)
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

Secondary Outcome Measures

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
Cost-effectiveness of NCD interventions
Comparison of costs and effects between intervention and business as usual, using diff in diff method

Full Information

First Posted
January 3, 2022
Last Updated
May 16, 2022
Sponsor
University Medical Center Groningen
Collaborators
University of Groningen, University of Passau, Universitas Sebelas Maret, Health Strategy and Policy Institute, Trnavska Universita v Trnava, HelpAge International, Thai Nguyễn University of Medicine and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT05239572
Brief Title
Scaling Up NCD Interventions in South East Asia
Acronym
SUNI-SEA
Official Title
Scaling Up Non-Communicable Diseases Interventions in South East Asia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
University of Groningen, University of Passau, Universitas Sebelas Maret, Health Strategy and Policy Institute, Trnavska Universita v Trnava, HelpAge International, Thai Nguyễn University of Medicine and Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases
Keywords
prevention, early diagnosis, lifestyle intervention

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In Vietnam members from 150 Intergenerational Self Help Clubs are invited to undergo screening for diabetes and cardiovascular diseases. (total number of persons between 7,500 and 15,000 persons) In Myanmar members from 150 Intergenerational Solidarity Groups are invited to undergo screening for diabetes and cardiovascular diseases. (total number of persons between 7,500 and 15,000 persons) In Indonesia, visitors of 20 Posbindu programmes are offered screened for diabetes and hypertension in Central and East Java (between 10,000 and 20,000 persons)
Masking
None (Open Label)
Allocation
N/A
Enrollment
25000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening and early detection of diabetes and cardiovascular diseases
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
screening, prevention and counselling
Other Intervention Name(s)
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
Intervention Description
Screening in Intergenerational solidarity clubs in Myanmar and Vietnam and in Posbindu programme in Indonesia
Primary Outcome Measure Information:
Title
Uptake of NCD screening offered in communities
Description
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
Title
Adherence to follow-up advice
Description
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
Title
Uptake of health education (health promotion, awareness of risk factors)
Description
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)
Secondary Outcome Measure Information:
Title
Unit costs of screening, prevention and early diagnosis of NCDs per Quality Adjusted Life Year gained
Description
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
Title
Cost-effectiveness of NCD interventions
Description
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
Other Pre-specified Outcome Measures:
Title
Impact of training of community health volunteers in NCD interventions on knowledge attitudes and practices of volunteers
Description
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
Title
Impact of training of community health volunteers on their performance in NCD interventions.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaap Koot, MD
Phone
+316224587689
Email
j.a.r.koot@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Hanneke Vervoort, MSc
Phone
+31619728837
Email
j.p.m.vervoort@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten Postma, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Lensink, PhD
Organizational Affiliation
University of Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ari Probandari, PhD
Organizational Affiliation
University Sebelas Maret
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giang Nguyen Hoang, MPH
Organizational Affiliation
Health Strategy and Policy Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anil Kumar Indira Krishna, PhD
Organizational Affiliation
HelpAge International
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Grimm, PhD
Organizational Affiliation
University of Passau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Strategy and Policy Institute
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giang Nguyen Hoang, MPH
Phone
=842438463808
Ext
5428
Email
nguyengiang@hspi.org.vn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.suni-sea.org
Links:
URL
http://www.suni-sea.org
Description
dedicated research project website

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Scaling Up NCD Interventions in South East Asia

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