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September 6, 2014BMC Public HealthOpen Access

A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale

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Key result

A simplified cardiovascular management program delivered by community health workers is being evaluated for its effect on antihypertensive medication use in high-risk patients in rural China and India.

Why the study?

Does a simplified cardiovascular management program delivered by community health workers improve antihypertensive medication use in high-risk patients in resource-constrained areas?

Population

High cardiovascular disease risk individuals in 40 villages in Tibet, China and Haryana, India.

Comparison

Simplified '2+2' intervention model involving… vs Usual care

Design

Other, Cluster-randomized, stratified by country

Follow-up

1 year

Authors

VAVamadevan S. AjayXLIMMTMaoyi TianPreventive CardiologyHCHao ChenUniversity of Science and Technology of China

Discussion

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Implication

This study design outlines a cluster-randomized trial to evaluate a community health worker-delivered simplified cardiovascular management program in resource-constrained areas of China and India.

Study Design

Type

RCT (n=2,000)

Randomization

Cluster-randomized

Multicenter

Yes

Structured PICO

Does a simplified cardiovascular management program delivered by community health workers improve antihypertensive medication use in high-risk patients in resource-constrained areas?

P
Population
High cardiovascular disease risk individuals (aged 40 years or older, history of heart disease, stroke, diabetes, or measured systolic blood pressure of 160 mmHg or higher) in 40 villages in Tibet, China and Haryana, India.
I
Intervention
Simplified '2+2' intervention model involving two lifestyle recommendations and the appropriate prescription of two medications, delivered by community health workers with an electronic decision support system, with monthly follow-up.
C
Comparator
Usual care
O
Outcome
Net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-interventionsurrogate

This study design outlines a cluster-randomized trial to evaluate a community health worker-delivered simplified cardiovascular management program in resource-constrained areas of China and India.

Limitations

  • Tibetan medicine beliefs may conflict with Western medicine
  • Gender relations in north India may pose constraints for female community health workers managing male patients

Cite This Study

Ajay et al. (2014) conducted an RCT in High cardiovascular disease risk (n=2,000). Simplified '2+2' cardiovascular management program vs. Usual care was evaluated on Net difference in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention. A simplified cardiovascular management program delivered by community health workers is being evaluated for its effect on antihypertensive medication use in high-risk patients in rural China and India.

synapsesocial.com/papers/6a1d74ce5b7fddc3520550c3https://doi.org/10.1186/1471-2458-14-924

Topics

Cardiovascular prevention
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