Cardiovascular DiseasesNCT06819839
Community-led Strategy to Reduce Cardiovascular Disease Risk Among Conflict-affected Populations
A study testing Village Health Worker (VHW) Care Model in people with Cardiovascular Diseases and Hypertension, run by Community Partners International at 1 site in Burma.
Trial summary
The goal of this study is to test a village health worker (VHW) based care model to reduce cardiovascular risk among adults in areas of eastern Myanmar affected by armed conflict. All individuals aged 40 years and above will be invited to participate in this study. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Diabetes
- What is being tested?
- Village Health Worker (VHW) Care Model
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteBurma
- Study dates
- 27 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 years or older
- Current resident of study villages
- No previous history of screening during the feasibility study a year ago
- At least one CVD risk factor
Who cannot join
- Currently pregnant or within three months postpartum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Community Health Worker Care Model to Reduce Cardiovascular Disease Risk Among Conflict-affected Populations in Eastern Myanmar: a Cluster Randomized Controlled Trial (cRCT)
The goal of this study is to test a village health worker (VHW) based care model to reduce cardiovascular risk among adults in areas of eastern Myanmar affected by armed conflict. All individuals aged 40 years and above will be invited to participate in this study. Participants will be checked whether they have a history of cardiovascular disease, diabetes (high blood sugar), high blood pressure or risk of developing cardiovascular disease by asking for medical history, measuring blood pressure, weight and height, and blood glucose if necessary. The main question the study aims to answer is:
Does villagers residing in the VHW supported villages have their blood pressure controlled, adherent to therapy and subsequently reduce the risk of developing cardiovascular disease after 5 months of monthly VHW home visits?
Read the detailed description
Myanmar is a Southeast Asian country which has been struggling with active conflict situation since 2021 - resulting massive internal displacement especially in ethnic areas. It is widely known that Community- and village-health worker (VHW) led interventions have reduced CVD risk in stable areas of low and middle income countries, but have not been adapted for internally displaced people (IDPs) exposed to active conflict. In addition, CVD is the leading cause of death in Myanmar and according to recent national survey, 75% of adults have at least one CVD risk factor.
This cRCT study is a third phase of the "Implementation of a community-led strategy to reduce cardiovascular disease risk among conflict-affected populations in eastern Myanmar" and Phase 1 and 2 have been successfully completed. The VHW care model was developed based on a Causal Loop Analysis (CLA) workshop in Phase 1 (GWU IRB# NCR234977), which included a Qualitative Study, Causal Loop Analysis workshop and Village Health Worker Intervention Design. The VHW care model was then tested in the Phase 2 Feasibility study (GWU IRB # NCR235114) in 3 villages conducted over three months (November 2023-January 2024).
Specific aim of this study includes:
- to assess the impact of a village health worker (VHW) care model in reducing cardiovascular disease (CVD) risk in rural Myanmar by conducting a cluster randomized trial in 13 villages surrounding 3 clinics. Hypothesis: High proportions of villagers over 40 are screened for elevated CVD risk (>90%), attend a confirmatory visit (>85%), initiate a high proportion of evidence-based therapies (>75%), participate in at least one follow-up visit (>70%) and are adherent to therapy at three months (>50%).
- to evaluate implementation of the VHW CVD program using the REAIM-PRISM framework. Hypothesis: The VHW CVD intervention has broad reach, is acceptable, effective, is widely adopted, and perceived to be sustainable by community partners.
- to establish the time and cost required to carry out VHW care model activities as well as their impact on the care cascade for CVD risk, from screening to linkage to care, initiation of therapy and retention in care.
Hypothesis: The VHW CVD intervention is cost-effective, affordable, and sustainable.
Advantage of the study:
The VHW care model extends basic monitoring and treatment functions for chronic disease management to remote rural villages where physical terrain, high transportation cost and insecurity limit options for transportation to and from centralized clinic locations. Via VHWs, patient medication adherence, blood pressure, and blood glucose (when relevant) will be reported to treating clinicians (medics). Medics will be able to use this information to either schedule an in-person visit or to remotely refill or titrate medications.
- Conditions
- Cardiovascular Diseases, Hypertension, Diabetes
- Being tested
- Village Health Worker (VHW) Care Model
- Keywords
- Cardiovascular disease (CVD), Village health worker, Eastern Myanmar, Hypertension, Diabetes, Care delivery model
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Village Health Worker (VHW) Care ModelBehavioural
VHW care model includes four components: (1) universal screening of all non-pregnant adults over 40 for elevated CVD risk (2) confirmatory visit to confirm diagnoses of hypertension, diabetes and elevated CVD risk (predicted 10-year risk >10%) (3) monthly household visits by VHW; (4) an mHealth tool (tablet computer) to assist with determination of study eligibility and provide recommendations for initiation of medications according to local guidelines. VHW household visits include: health education on smoking cessation, healthy diet, physical activity and medication adherence; assessment of possible medication side effects, measurement of blood pressure and (when applicable) blood glucose; review monitoring results with the treating clinician household delivery of medications; and facilitate referral and transport to higher levels of care.
| Study group | Role | What they receive |
|---|---|---|
| Village Health Worker (VHW) Care Model | Experimental | 7 villages are randomly selected and people (40 years and above) with increased cardiovascular disease risk receive VHW Care Receives: Behavioral: Village Health Worker (VHW) Care Model |
| Standard Community Care | No intervention | 6 control villages randomly selected from 6 matched pairs and triplets of villages, and conduct a baseline and endline survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence - self-reported MARS-5
Proportion of individuals adherent to evidence-based medications (taking the medication within the past 2 weeks, from self-report), AND a medication adherence report scale (MARS-5) adherence score of at least 16 out of 25. Requires taking at least one medication from each of the classes for which the individual is eligible: anti-hypertensive medication for individuals with hypertension, and statin for individuals with a history of ischemic heart disease, history of stroke, diabetes or 10-year CVD risk >10%.
Measured: 5 months
Secondary outcomes (56)
Change in medication adherence - self reported high
Proportion of individuals with high self reported adherence to evidence-based medications for which they are eligible. Requires taking at least one medication from each of the classes for which the individual is eligible (see primary outcome), AND a MARS-5 adherence scale of at least 20 out of 25. The MARS-5 adherence scale has a range from 5 to 25, with higher scores representing higher self-reported adherence.
Measured: 5 months
Change in medication adherence - lenient
Proportion of individual taking at least one among any of the evidence-based medication classes s/he is eligible for (less strict definition medication adherence)
Measured: 5 months
Change in population level adherence
Population level adherence, calculated as the ratio of the sum of the medication classes taken divided by the sum of eligible medication classes, among all individuals in the group. For example, if individual 1 is eligible for and takes one medication and if individual is eligible for two medications but takes only one, then population level adherence = (1+1) / (1+ 2) = 0.66.
Measured: 5 months
Change in adherence to blood pressure medication
Respective proportions reporting 'moderate' or 'high' adherence to blood pressure medications using 'low' (5 to 15), 'moderate' (16 to 20) or 'high' (21-25) on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, with higher scores representing higher self-reported adherence.
Measured: 5 months
Change in adherence to statin medication
Respective proportions reporting 'low', 'moderate' or 'high' adherence to blood pressure medications using 'low' (5 to 15), 'moderate' (16 to 20) or 'high' (21-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, with higher scores representing higher self-reported adherence.
Measured: 5 months
Change in mean MARS-5 adherence score
Among individuals eligible for either blood pressure or statin medication. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Measured: 5 months
Change in first and recurrent CVD event risk
Change in CVD event risk is assessed using a modified relative risk reduction tool that accurately quantifies longitudinal changes in cardiovascular disease risk.
Measured: 5 months
Change in mean CVD risk predicted by World Health Organization CVD risk calculator
Change in mean CVD risk is the difference between the mean 10-year CVD risk of participants eligible for treatment at endline and the mean 10-year CVD risk of eligible individuals at baseline, as calculated using the WHO CVD risk equation. This method is known to inaccurately estimate change in CVD risk; it is reported for the sake of comparison to studies that (mis)use the WHO risk equation to define outcomes.
Measured: 5 months
Change in relative Go Score
The relative GO score is defined as the proportion of benefit (relative CVD risk reduction) achieved, out of the maximum benefit possible from guideline directed therapy. The two therapies in the current study are blood pressure medications and statins. The GO Score has minimum value of zero and maximum value of one, with higher values representing a better outcome (greater proportion of possible benefit achieved). The relative GO Score is calculated using the ratio of relative risk reduction achieved divided by the relative risk reduction possible.
Measured: 5 months
Change in absolute Go Score
The absolute GO score is defined as the proportion of absolute benefit (absolute CVD risk reduction) achieved, out of the maximum benefit possible from guideline directed therapy. The two therapies in the current study are blood pressure medications and statins. The GO Score has minimum value of zero and maximum value of one, with higher values representing a better outcome (greater proportion of possible benefit achieved). The absolute GO Score is calculated using the ratio of absolute risk reduction achieved to the absolute risk reduction possible.
Measured: 5 months
Care cascade step 1: proportion aware of their diagnosis
Proportion of the number of participants aware of their diagnoses (hypertension, diabetes and elevated CVD risk) to adults over 40 years eligible for statins, anti-hypertensive treatment, or both statins and anti-hypertensives
Measured: 5 months
Care cascade step 2: proportion linked to care
Proportion of participants linked to care (at least 1 clinic visit or VHW visit for CVD risk management) among adults over 40 years eligible for treatment
Measured: 5 months
Care cascade step 3: proportion initiated on appropriate medications
Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Measured: 5 months
Care cascade step 4: proportion taking appropriate medication
Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Measured: 5 months
Care cascade step 5: proportion adherent to treatment
Proportion of participants who report taking appropriate medication in the past two weeks AND who report adherence to treatment, where adherence is defined as 16-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Measured: 5 months
Hypertension Care cascade step 1: proportion aware of their diagnosis
Proportion of the number of participants aware of their diagnoses (hypertension, diabetes and elevated CVD risk) to adults over 40 years eligible for statins, anti-hypertensive treatment, or both statins and anti-hypertensives
Measured: 5 months
Hypertension Care cascade step 2: proportion linked to care
Proportion of participants linked to care (at least 1 clinic visit or VHW visit for CVD risk management) among adults over 40 years eligible for treatment
Measured: 5 months
Hypertension Care cascade step 3: proportion initiated on appropriate medications
Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Measured: 5 months
Hypertension Care cascade step 4: proportion taking appropriate medication
Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Measured: 5 months
Hypertension Care cascade step 5: proportion adherent to treatment
Proportion of participants who report taking appropriate medication in the past two weeks AND who report adherence to treatment, where adherence is defined as 16-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Measured: 5 months
Hypertension Care cascade step 6: proportion with systolic blood pressure below 140mmHg
Proportion of participants with systolic blood pressure below 140mmHg among adults over 40 years with hypertension
Measured: 5 months
Hypertension Care cascade step 7: proportion with systolic blood pressure below 130mmHg
Proportion of participants with systolic blood pressure below 130mmHg among adults over 40 years with hypertension
Measured: 5 months
Hypertension Care cascade step 8: proportion with systolic blood pressure below 120mmHg
Proportion of participants with systolic blood pressure below 120mmHg among adults over 40 years with hypertension
Measured: 5 months
Statin care cascade step 1: proportion linked to care
Proportion of participants linked to care (at least 1 clinic visit or VHW visit for CVD risk management) among adults over 40 years eligible for statin treatment
Measured: 5 months
Statin care cascade step 2: proportion initiated on appropriate medications
Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Measured: 5 months
Statin care cascade step 3: proportion taking appropriate medication
Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Measured: 5 months
Statin care cascade step 4: proportion adherent to statin treatment
Proportion of participants who report taking appropriate medication in the past two weeks AND who report adherence to treatment, where adherence is defined as 16-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Measured: 5 months
Change in mean systolic blood pressure in the hypertensive population
Changes in blood pressure is the difference between the mean systolic blood pressure at baseline and the mean systolic blood pressure at endline, among individuals with likely hypertension, defined as taking anti-hypertensive treatment.
Measured: 5 months
Change in current smoking prevalence
Current smoking is assessed by an affirmative answer to the question "In the past two weeks have participant smoked any tobacco products, such as cigarettes, cigars or pipes?", asked on individuals with likely eligible for blood pressure medication or statin treatment. Smoking prevalence is defined as the proportion of current smokers among all adults 40 years or older.
Measured: 5 months
Mean change in systolic blood pressure among individuals with hypertension who have repeated measures
Changes in systolic blood pressure is the (paired) mean difference in systolic blood pressure from baseline to endline change , among individuals with likely hypertension who have measurements at baseline and endline. In intervention villages individuals with repeated measures were assessed during village screening at baseline and the endline assessments; in control villages individuals with repeated measures represent approximately one-quarter of individuals who expected to participate in both baseline and endline household surveys (both surveys target half of all households, hence the probability of being selected at both baseline and endline is approximately 0.25).
Measured: 5 months
Smoking cessation (quit) rate among smokers with repeated measures
Current smoking is assessed by an affirmative answer to the question "In the past two weeks have participant smoked any tobacco products, such as cigarettes, cigars or pipes?", asked of individuals eligible for anti-hypertension or statin treatment. Smoking cessation (quite rate) is defined as the proportion of current smokers at baseline who do not report current smoking at endline. In intervention villages individuals with repeated measures were assessed during village screening at baseline and the endline assessments; in control villages individuals with repeated measures represent approximately one-quarter of individuals who expected to participate in both baseline and endline household surveys (both surveys target half of all households, hence the probability of being selected at both baseline and endline is approximately 0.25).
Measured: 5 months
Change in medication adherence among individuals with repeated measures
Proportion of individuals adherent to evidence-based medications (taking the medication within the past 2 weeks, from self-report), AND a medication adherence report scale (MARS-5) adherence score of at least 16 out of 25. Requires taking at least one medication from each of the classes for which the individual is eligible: anti-hypertensive medication for individuals with hypertension, and statin for individuals with a history of ischemic heart disease, history of stroke, diabetes or 10-year CVD risk >10%. In intervention villages individuals with repeated measures were assessed during village screening at baseline and the endline assessments; in control villages individuals with repeated measures represent approximately one-quarter of individuals who expected to participate in both baseline and endline household surveys (both surveys target half of all households, hence the probability of being selected at both baseline and endline is approximately 0.25).
Measured: 5 months
Changes in GO Score among individuals with repeated measures
Changes in GO Score is the difference between observed changes in blood pressure and smoking cessation among individuals at endline AND observed changes in blood pressure and smoking cessation among individuals at baseline. The GO Score has minimum value of zero and maximum value of one, with higher values representing a better outcome (greater proportion of possible benefit achieved).
Measured: 5 months
Effect modification by presence of a disability
Disability is defined as either "a lot of difficulty" or "cannot do at all" in relation to at least one of 8 disability function items from the Washington Group - Extended Set on Function (WG-ES)
Measured: 5 months
Effect modification by 10-year (predicted) CVD risk
Using 10-year (predicted) CVD risk
Measured: 5 months
Effect modification by Sex
Stratified by male and female
Measured: 5 months
Effect modification by Age
Stratified by age groups (40-49 years, 50-59, 60-69, 70+)
Measured: 5 months
Effect modification by household wealth
Using Myanmar wealth quintiles defined by Equity tool
Measured: 5 months
Effect modification by respondent educational attainment
Using Educational attainment
Measured: 5 months
Effect modification by income
Using level of income
Measured: 5 months
Effect modification by residential status in the village
Residential status is defined as arrival before/after initial screening (dichotomous)
Measured: 5 months
Multidimensional index of vulnerability
The multidimensional index of vulnerability will be calculated as a multivariate propensity score of the primary dichotomous outcome, using the predicted probability from a logistic regression model that includes multiple axes of disadvantage as predictors including household wealth, educational attainment, income, women's empowerment and distance from a health facility. The index has a minimum value of 0 and maximum value of 1. Increasing values represent higher vulnerability.
Measured: 5 months
Changes in relative inequities in primary and secondary outcomes: the relative concentration index
Relative health inequities will be summarized on the relative scale using the relative concentration index, a summary health equity metric developed by the World Bank. The relative concentration index has a range from zero to 1 (though the range for dichotomous outcomes is 'bounded', with a lower maximum value that varies as a function of the proportion of the outcome.
Measured: 5 months
Changes in absolute inequities in primary and secondary outcomes: the absolute concentration index
Absolute health inequities will be summarized on the absolute scale using the absolute concentration index, a summary health equity metric developed by the World Bank, and equal to the mean value in the population multiplied by the relative concentration index (see Wagstaff et al 2002).
Measured: 5 months
Changes in equity-weighted primary and secondary outcomes: the achievement index
We will calculate the achievement index, an equity-weighted health outcome metric developed by the World Bank, and equal to the mean value in the population multiplied by (1 minus the relative concentration index); (see Wagstaff et al 2002).
Measured: 5 months
Linkage to care cascade 1: proportion of adults screened for CVD risk factors
Proportion of population >40 years old who complete screening questionnaire, in intervention villages
Measured: 5 months
Linkage to care cascade 2: proportion of adults who complete a confirmatory visit
Proportion of population >40 years old who complete confirmatory visit, among adults eligible for a confirmatory visit
Measured: 5 months
Linkage to care cascade 3: proportion of adults eligible for the longitudinal study who attended at least one VHW visit
Proportion of adults eligible for the longitudinal study who attended at least one VHW visit
Measured: 5 months
Linkage to care cascade 4: proportion retained in care at the end of the study
Retained in care is defined as not withdrawn from the study participated in a VHW visit in the previous 60 days
Measured: 5 months
Mean number (n, %) of VHW visits completed
Mean number (n, %) of VHW visits completed among eligible population
Measured: 5 months
Mean number (n, %) of medic visits per participant
Mean number (n, %) of medic visits per participant among eligible population
Measured: 5 months
Refused participation, among eligible individuals (n, %)
Number (n, %) of individuals among eligible population who refused to participate in the study
Measured: 5 months
Withdrew from study
Number (n, %) of individuals among eligible population who withdrew from study
Measured: 5 months
Deceased (n, %)
Number (n,%) of individuals among eligible population who died during the duration of the study
Measured: 5 months
Referrals for acute symptoms or other complication
Number (n, %) of individuals among eligible population who received referrals for acute symptoms or other complication
Measured: 5 months
Proportion of visits with adequate quality clinical decision-making
Proportion of visits with adequate quality clinical decision-making from a logbook chart review
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start27 Oct 2024
- Primary completion30 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Controlled Trial in 13 villages
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Partners International
- Sponsor type
- University, hospital or other
- Collaborators
- Khon Kaen University, George Washington University, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Adam Richards, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819839
- Sponsor's protocol ID
- NCR245957
- Status last verified
- Dec 2024
- First submitted
- 25 Jan 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagamine Y, Shobugawa Y, Sasaki Y, Takagi D, Fujiwara T, Khin YP, Nozaki I, Shirakura Y, Kay Thi L, Poe Ei Z, Thae Z, Win HH. Associations between socioeconomic status and adherence to hypertension treatment among older adults in urban and rural areas in Myanmar: a cross-sectional study using baseline data from the JAGES in Myanmar prospective cohort study. BMJ Open. 2023 Jan 17;13(1):e065370. doi: 10.1136/bmjopen-2022-065370.
PubMed 36653052Lloyd-Jones DM, Huffman MD, Karmali KN, Sanghavi DM, Wright JS, Pelser C, Gulati M, Masoudi FA, Goff DC Jr. Estimating Longitudinal Risks and Benefits From Cardiovascular Preventive Therapies Among Medicare Patients: The Million Hearts Longitudinal ASCVD Risk Assessment Tool: A Special Report From the American Heart Association and American College of Cardiology. Circulation. 2017 Mar 28;135(13):e793-e813. doi: 10.1161/CIR.0000000000000467. Epub 2016 Nov 4.
PubMed 27815375Kaur G, Chauhan AS, Prinja S, Teerawattananon Y, Muniyandi M, Rastogi A, Jyani G, Nagarajan K, Lakshmi P, Gupta A, Selvam JM, Bhansali A, Jain S. Cost-effectiveness of population-based screening for diabetes and hypertension in India: an economic modelling study. Lancet Public Health. 2022 Jan;7(1):e65-e73. doi: 10.1016/S2468-2667(21)00199-7. Epub 2021 Nov 12.
PubMed 34774219Basu S, Wagner RG, Sewpaul R, Reddy P, Davies J. Implications of scaling up cardiovascular disease treatment in South Africa: a microsimulation and cost-effectiveness analysis. Lancet Glob Health. 2019 Feb;7(2):e270-e280. doi: 10.1016/S2214-109X(18)30450-9. Epub 2018 Dec 6.
PubMed 30528531Brownell NK, Ziaeian B, Jackson NJ, Richards AK. Trends in Income Inequities in Cardiovascular Health Among US Adults, 1988-2018. Circ Cardiovasc Qual Outcomes. 2024 May;17(5):e010111. doi: 10.1161/CIRCOUTCOMES.123.010111. Epub 2024 Apr 3.
PubMed 38567505Patel A, Praveen D, Maharani A, Oceandy D, Pilard Q, Kohli MPS, Sujarwoto S, Tampubolon G. Association of Multifaceted Mobile Technology-Enabled Primary Care Intervention With Cardiovascular Disease Risk Management in Rural Indonesia. JAMA Cardiol. 2019 Oct 1;4(10):978-986. doi: 10.1001/jamacardio.2019.2974.
PubMed 31461123Schwalm JD, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, Camacho PA, Majid F, Bangdiwala SI, Thabane L, Islam S, McKee M, Yusuf S. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019 Oct 5;394(10205):1231-1242. doi: 10.1016/S0140-6736(19)31949-X. Epub 2019 Sep 2.
PubMed 31488369Jafar TH, Jehan I, de Silva HA, Naheed A, Gandhi M, Assam P, Finkelstein EA, Quigley HL, Bilger M, Khan AH, Clemens JD, Ebrahim S, Turner EL; for COBRA-BPS Study Group; Kasturiratne A. Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial. Trials. 2017 Jun 12;18(1):272. doi: 10.1186/s13063-017-2018-0.
PubMed 28606184Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, Turner EL, Morisky D, Kasturiratne A, Khan AH, Clemens JD, Ebrahim S, Assam PN, Feng L; COBRA-BPS Study Group. A Community-Based Intervention for Managing Hypertension in Rural South Asia. N Engl J Med. 2020 Feb 20;382(8):717-726. doi: 10.1056/NEJMoa1911965.
PubMed 32074419Patenaude B, Odihi D, Sriudomporn S, Mak J, Watts E, de Broucker G. A standardized approach for measuring multivariate equity in vaccination coverage, cost-of-illness, and health outcomes: Evidence from the Vaccine Economics Research for Sustainability & Equity (VERSE) project. Soc Sci Med. 2022 Jun;302:114979. doi: 10.1016/j.socscimed.2022.114979. Epub 2022 Apr 16.
PubMed 35462106Chakraborty NM, Fry K, Behl R, Longfield K. Simplified Asset Indices to Measure Wealth and Equity in Health Programs: A Reliability and Validity Analysis Using Survey Data From 16 Countries. Glob Health Sci Pract. 2016 Mar 25;4(1):141-54. doi: 10.9745/GHSP-D-15-00384. Print 2016 Mar.
PubMed 27016550Eddy DM, Adler J, Morris M. The 'Global Outcomes Score': a quality measure, based on health outcomes, that compares current care to a target level of care. Health Aff (Millwood). 2012 Nov;31(11):2441-50. doi: 10.1377/hlthaff.2011.1274.
PubMed 23129674Spetz K, Olbers T, Ostbring M, Moon Z, Horne R, Andersson E. Using the 5-Item Medication Adherence Report Scale (MARS-5) to Screen for Non-adherence to Vitamin and Mineral Supplementation After Bariatric Surgery. Obes Surg. 2024 Feb;34(2):576-582. doi: 10.1007/s11695-023-07027-x. Epub 2024 Jan 4.
PubMed 38177555Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18.
PubMed 31823381Richards A. Cardiovascular risk in hypertension: open questions about HOPE 4. Lancet. 2020 Aug 1;396(10247):310. doi: 10.1016/S0140-6736(20)30613-9. No abstract available.
PubMed 32738948
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Community Health Worker Care Model to Reduce Cardiovascular Disease Risk Among Conflict-affected Populations in Eastern Myanmar: a Cluster Randomized Controlled Trial (cRCT)
- ClinicalTrials.gov ID
- NCT06819839
- Acronym / sponsor ID
- NCR245957
- Conditions
- Cardiovascular Diseases, Hypertension, Diabetes
- Keywords
- Cardiovascular disease (CVD), Village health worker, Eastern Myanmar, Hypertension, Diabetes, Care delivery model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Community Partners InternationalUniversity, hospital or other
- Collaborators
- Khon Kaen University, George Washington University, University of California, San Diego
- Study start
- 27 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test a village health worker (VHW) based care model to reduce cardiovascular risk among adults in areas of eastern Myanmar affected by armed conflict. All individuals aged 40 years and above will be invited to participate in this study. Participants will be checked whether they have a history of cardiovascular disease, diabetes (high blood sugar), high blood pressure or risk of developing cardiovascular disease by asking for medical history, measuring blood pressure, weight and height, and blood glucose if necessary. The main question the study aims to answer is:
Does villagers residing in the VHW supported villages have their blood pressure controlled, adherent to therapy and subsequently reduce the risk of developing cardiovascular disease after 5 months of monthly VHW home visits?
Detailed description
Myanmar is a Southeast Asian country which has been struggling with active conflict situation since 2021 - resulting massive internal displacement especially in ethnic areas. It is widely known that Community- and village-health worker (VHW) led interventions have reduced CVD risk in stable areas of low and middle income countries, but have not been adapted for internally displaced people (IDPs) exposed to active conflict. In addition, CVD is the leading cause of death in Myanmar and according to recent national survey, 75% of adults have at least one CVD risk factor.
This cRCT study is a third phase of the "Implementation of a community-led strategy to reduce cardiovascular disease risk among conflict-affected populations in eastern Myanmar" and Phase 1 and 2 have been successfully completed. The VHW care model was developed based on a Causal Loop Analysis (CLA) workshop in Phase 1 (GWU IRB# NCR234977), which included a Qualitative Study, Causal Loop Analysis workshop and Village Health Worker Intervention Design. The VHW care model was then tested in the Phase 2 Feasibility study (GWU IRB # NCR235114) in 3 villages conducted over three months (November 2023-January 2024).
Specific aim of this study includes:
- to assess the impact of a village health worker (VHW) care model in reducing cardiovascular disease (CVD) risk in rural Myanmar by conducting a cluster randomized trial in 13 villages surrounding 3 clinics. Hypothesis: High proportions of villagers over 40 are screened for elevated CVD risk (>90%), attend a confirmatory visit (>85%), initiate a high proportion of evidence-based therapies (>75%), participate in at least one follow-up visit (>70%) and are adherent to therapy at three months (>50%).
- to evaluate implementation of the VHW CVD program using the REAIM-PRISM framework. Hypothesis: The VHW CVD intervention has broad reach, is acceptable, effective, is widely adopted, and perceived to be sustainable by community partners.
- to establish the time and cost required to carry out VHW care model activities as well as their impact on the care cascade for CVD risk, from screening to linkage to care, initiation of therapy and retention in care.
Hypothesis: The VHW CVD intervention is cost-effective, affordable, and sustainable.
Advantage of the study:
The VHW care model extends basic monitoring and treatment functions for chronic disease management to remote rural villages where physical terrain, high transportation cost and insecurity limit options for transportation to and from centralized clinic locations. Via VHWs, patient medication adherence, blood pressure, and blood glucose (when relevant) will be reported to treating clinicians (medics). Medics will be able to use this information to either schedule an in-person visit or to remotely refill or titrate medications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Controlled Trial in 13 villages
| Arm | Type | Receives |
|---|---|---|
| Village Health Worker (VHW) Care Model | Experimental | Behavioral: Village Health Worker (VHW) Care Model7 villages are randomly selected and people (40 years and above) with increased cardiovascular disease risk receive VHW Care |
| Standard Community Care | No intervention | –6 control villages randomly selected from 6 matched pairs and triplets of villages, and conduct a baseline and endline survey |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 40 years or older
- Current resident of study villages
- No previous history of screening during the feasibility study a year ago
- At least one CVD risk factor
Key exclusion criteria (1 listed)
- Currently pregnant or within three months postpartum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Village Health Worker (VHW) Care ModelVHW care model includes four components: (1) universal screening of all non-pregnant adults over 40 for elevated CVD risk (2) confirmatory visit to confirm diagnoses of hypertension, diabetes and elevated CVD risk (predicted 10-year risk >10%) (3) monthly household visits by VHW; (4) an mHealth tool (tablet computer) to assist with determination of study eligibility and provide recommendations for initiation of medications according to local guidelines. VHW household visits include: health education on smoking cessation, healthy diet, physical activity and medication adherence; assessment of possible medication side effects, measurement of blood pressure and (when applicable) blood glucose; review monitoring results with the treating clinician household delivery of medications; and facilitate referral and transport to higher levels of care. | Behavioural | Village Health Worker (VHW) Care Model |
Primary outcome
Change in medication adherence - self-reported MARS-5
Time frame: 5 months
Proportion of individuals adherent to evidence-based medications (taking the medication within the past 2 weeks, from self-report), AND a medication adherence report scale (MARS-5) adherence score of at least 16 out of 25. Requires taking at least one medication from each of the classes for which the individual is eligible: anti-hypertensive medication for individuals with hypertension, and statin for individuals with a history of ischemic heart disease, history of stroke, diabetes or 10-year CVD risk >10%.
56 secondary outcomes
Change in medication adherence - self reported high
Time frame: 5 months
Change in medication adherence - lenient
Time frame: 5 months
Change in population level adherence
Time frame: 5 months
Change in adherence to blood pressure medication
Time frame: 5 months
Change in adherence to statin medication
Time frame: 5 months
Change in mean MARS-5 adherence score
Time frame: 5 months
Change in first and recurrent CVD event risk
Time frame: 5 months
Change in mean CVD risk predicted by World Health Organization CVD risk calculator
Time frame: 5 months
Change in relative Go Score
Time frame: 5 months
Change in absolute Go Score
Time frame: 5 months
Care cascade step 1: proportion aware of their diagnosis
Time frame: 5 months
Care cascade step 2: proportion linked to care
Time frame: 5 months
Care cascade step 3: proportion initiated on appropriate medications
Time frame: 5 months
Care cascade step 4: proportion taking appropriate medication
Time frame: 5 months
Care cascade step 5: proportion adherent to treatment
Time frame: 5 months
Hypertension Care cascade step 1: proportion aware of their diagnosis
Time frame: 5 months
Hypertension Care cascade step 2: proportion linked to care
Time frame: 5 months
Hypertension Care cascade step 3: proportion initiated on appropriate medications
Time frame: 5 months
Hypertension Care cascade step 4: proportion taking appropriate medication
Time frame: 5 months
Hypertension Care cascade step 5: proportion adherent to treatment
Time frame: 5 months
Hypertension Care cascade step 6: proportion with systolic blood pressure below 140mmHg
Time frame: 5 months
Hypertension Care cascade step 7: proportion with systolic blood pressure below 130mmHg
Time frame: 5 months
Hypertension Care cascade step 8: proportion with systolic blood pressure below 120mmHg
Time frame: 5 months
Statin care cascade step 1: proportion linked to care
Time frame: 5 months
Statin care cascade step 2: proportion initiated on appropriate medications
Time frame: 5 months
Statin care cascade step 3: proportion taking appropriate medication
Time frame: 5 months
Statin care cascade step 4: proportion adherent to statin treatment
Time frame: 5 months
Change in mean systolic blood pressure in the hypertensive population
Time frame: 5 months
Change in current smoking prevalence
Time frame: 5 months
Mean change in systolic blood pressure among individuals with hypertension who have repeated measures
Time frame: 5 months
Smoking cessation (quit) rate among smokers with repeated measures
Time frame: 5 months
Change in medication adherence among individuals with repeated measures
Time frame: 5 months
Changes in GO Score among individuals with repeated measures
Time frame: 5 months
Effect modification by presence of a disability
Time frame: 5 months
Effect modification by 10-year (predicted) CVD risk
Time frame: 5 months
Effect modification by Sex
Time frame: 5 months
Effect modification by Age
Time frame: 5 months
Effect modification by household wealth
Time frame: 5 months
Effect modification by respondent educational attainment
Time frame: 5 months
Effect modification by income
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 36653052Nagamine Y, Shobugawa Y, Sasaki Y, Takagi D, Fujiwara T, Khin YP, Nozaki I, Shirakura Y, Kay Thi L, Poe Ei Z, Thae Z, Win HH. Associations between socioeconomic status and adherence to hypertension treatment among older adults in urban and rural areas in Myanmar: a cross-sectional study using baseline data from the JAGES in Myanmar prospective cohort study. BMJ Open. 2023 Jan 17;13(1):e065370. doi: 10.1136/bmjopen-2022-065370.
- Background: PubMed 27815375Lloyd-Jones DM, Huffman MD, Karmali KN, Sanghavi DM, Wright JS, Pelser C, Gulati M, Masoudi FA, Goff DC Jr. Estimating Longitudinal Risks and Benefits From Cardiovascular Preventive Therapies Among Medicare Patients: The Million Hearts Longitudinal ASCVD Risk Assessment Tool: A Special Report From the American Heart Association and American College of Cardiology. Circulation. 2017 Mar 28;135(13):e793-e813. doi: 10.1161/CIR.0000000000000467. Epub 2016 Nov 4.
- Background: PubMed 34774219Kaur G, Chauhan AS, Prinja S, Teerawattananon Y, Muniyandi M, Rastogi A, Jyani G, Nagarajan K, Lakshmi P, Gupta A, Selvam JM, Bhansali A, Jain S. Cost-effectiveness of population-based screening for diabetes and hypertension in India: an economic modelling study. Lancet Public Health. 2022 Jan;7(1):e65-e73. doi: 10.1016/S2468-2667(21)00199-7. Epub 2021 Nov 12.
- Background: PubMed 30528531Basu S, Wagner RG, Sewpaul R, Reddy P, Davies J. Implications of scaling up cardiovascular disease treatment in South Africa: a microsimulation and cost-effectiveness analysis. Lancet Glob Health. 2019 Feb;7(2):e270-e280. doi: 10.1016/S2214-109X(18)30450-9. Epub 2018 Dec 6.
- Background: PubMed 38567505Brownell NK, Ziaeian B, Jackson NJ, Richards AK. Trends in Income Inequities in Cardiovascular Health Among US Adults, 1988-2018. Circ Cardiovasc Qual Outcomes. 2024 May;17(5):e010111. doi: 10.1161/CIRCOUTCOMES.123.010111. Epub 2024 Apr 3.
- Background: PubMed 31461123Patel A, Praveen D, Maharani A, Oceandy D, Pilard Q, Kohli MPS, Sujarwoto S, Tampubolon G. Association of Multifaceted Mobile Technology-Enabled Primary Care Intervention With Cardiovascular Disease Risk Management in Rural Indonesia. JAMA Cardiol. 2019 Oct 1;4(10):978-986. doi: 10.1001/jamacardio.2019.2974.
- Background: PubMed 31488369Schwalm JD, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, Camacho PA, Majid F, Bangdiwala SI, Thabane L, Islam S, McKee M, Yusuf S. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019 Oct 5;394(10205):1231-1242. doi: 10.1016/S0140-6736(19)31949-X. Epub 2019 Sep 2.
- Background: PubMed 28606184Jafar TH, Jehan I, de Silva HA, Naheed A, Gandhi M, Assam P, Finkelstein EA, Quigley HL, Bilger M, Khan AH, Clemens JD, Ebrahim S, Turner EL; for COBRA-BPS Study Group; Kasturiratne A. Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial. Trials. 2017 Jun 12;18(1):272. doi: 10.1186/s13063-017-2018-0.
- Background: PubMed 32074419Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, Turner EL, Morisky D, Kasturiratne A, Khan AH, Clemens JD, Ebrahim S, Assam PN, Feng L; COBRA-BPS Study Group. A Community-Based Intervention for Managing Hypertension in Rural South Asia. N Engl J Med. 2020 Feb 20;382(8):717-726. doi: 10.1056/NEJMoa1911965.
- Background: PubMed 35462106Patenaude B, Odihi D, Sriudomporn S, Mak J, Watts E, de Broucker G. A standardized approach for measuring multivariate equity in vaccination coverage, cost-of-illness, and health outcomes: Evidence from the Vaccine Economics Research for Sustainability & Equity (VERSE) project. Soc Sci Med. 2022 Jun;302:114979. doi: 10.1016/j.socscimed.2022.114979. Epub 2022 Apr 16.
- Background: PubMed 27016550Chakraborty NM, Fry K, Behl R, Longfield K. Simplified Asset Indices to Measure Wealth and Equity in Health Programs: A Reliability and Validity Analysis Using Survey Data From 16 Countries. Glob Health Sci Pract. 2016 Mar 25;4(1):141-54. doi: 10.9745/GHSP-D-15-00384. Print 2016 Mar.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Richards principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Village Health Worker (VHW) Care Model in people with Cardiovascular Diseases and Hypertension, run by Community Partners International at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence - self-reported MARS-5 (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06819839, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.