Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD)

Deepak Y. Kamath, Denis Xavier, Rajeev Gupta, P. J. Devereaux, Alben Sigamani, Tanvir Hussain, Sowmya Umesh, Freeda Xavier, Preeti Girish, Nisha George, Tinku Thomas, N. Chidambaram, Rajnish Joshi, Prem Pais, Salim Yusuf

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease. There are no studies from low- to middle income countries (LMICs) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease.

Methods: We designed a hospital-based, open randomized trial of CHW-based interventions versus standard care. Patients after an acute coronary syndrome (ACS) were randomized to an intervention group (a CHW-based intervention package, comprising education tools to enhance self-care and adherence, and regular follow-up by the CHW) or to standard care for 12 months during which study outcomes were recorded. The CHWs were trained over a period of 6 months. The primary outcome measure was medication adherence. The secondary outcomes were differences in adherence to lifestyle modification, physiological parameters (blood pressure [BP], body weight, body mass index [BMI], heart rate, lipids), and major adverse cardiovascular events.

Results: We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities. The mean age was 56.4 (±11.32) years, and 17.2% were females. A high prevalence of risk factors such as hypertension (43.4%), diabetes (31.9%), tobacco consumption (35.4%), and inadequate physical activity (70.5%) was documented. A little over half had ST-elevation myocardial infarction (53.7%), and 46.3% had non-ST-elevation myocardial infarction or unstable angina.

Conclusion: The CHW interventions and training for SPREAD have been developed and adapted for local use. The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries.

Original languageEnglish (US)
Pages (from-to)690-697
Number of pages8
JournalAmerican Heart Journal
Volume168
Issue number5
DOIs
StatePublished - Nov 1 2014

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Acute Coronary Syndrome
Secondary Prevention
India
Randomized Controlled Trials
Coronary Disease
Outcome Assessment (Health Care)
Medication Adherence
Unstable Angina
Tobacco Use
Self Care
Life Style
Body Mass Index
Cardiovascular Diseases
Heart Rate
Body Weight
Exercise
Blood Pressure
Hypertension
Lipids
Education

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD). / Kamath, Deepak Y.; Xavier, Denis; Gupta, Rajeev; Devereaux, P. J.; Sigamani, Alben; Hussain, Tanvir; Umesh, Sowmya; Xavier, Freeda; Girish, Preeti; George, Nisha; Thomas, Tinku; Chidambaram, N.; Joshi, Rajnish; Pais, Prem; Yusuf, Salim.

In: American Heart Journal, Vol. 168, No. 5, 01.11.2014, p. 690-697.

Research output: Contribution to journalArticle

Kamath, DY, Xavier, D, Gupta, R, Devereaux, PJ, Sigamani, A, Hussain, T, Umesh, S, Xavier, F, Girish, P, George, N, Thomas, T, Chidambaram, N, Joshi, R, Pais, P & Yusuf, S 2014, 'Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD)', American Heart Journal, vol. 168, no. 5, pp. 690-697. https://doi.org/10.1016/j.ahj.2014.07.029
Kamath, Deepak Y. ; Xavier, Denis ; Gupta, Rajeev ; Devereaux, P. J. ; Sigamani, Alben ; Hussain, Tanvir ; Umesh, Sowmya ; Xavier, Freeda ; Girish, Preeti ; George, Nisha ; Thomas, Tinku ; Chidambaram, N. ; Joshi, Rajnish ; Pais, Prem ; Yusuf, Salim. / Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD). In: American Heart Journal. 2014 ; Vol. 168, No. 5. pp. 690-697.
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abstract = "Background: There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease. There are no studies from low- to middle income countries (LMICs) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease.Methods: We designed a hospital-based, open randomized trial of CHW-based interventions versus standard care. Patients after an acute coronary syndrome (ACS) were randomized to an intervention group (a CHW-based intervention package, comprising education tools to enhance self-care and adherence, and regular follow-up by the CHW) or to standard care for 12 months during which study outcomes were recorded. The CHWs were trained over a period of 6 months. The primary outcome measure was medication adherence. The secondary outcomes were differences in adherence to lifestyle modification, physiological parameters (blood pressure [BP], body weight, body mass index [BMI], heart rate, lipids), and major adverse cardiovascular events.Results: We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities. The mean age was 56.4 (±11.32) years, and 17.2{\%} were females. A high prevalence of risk factors such as hypertension (43.4{\%}), diabetes (31.9{\%}), tobacco consumption (35.4{\%}), and inadequate physical activity (70.5{\%}) was documented. A little over half had ST-elevation myocardial infarction (53.7{\%}), and 46.3{\%} had non-ST-elevation myocardial infarction or unstable angina.Conclusion: The CHW interventions and training for SPREAD have been developed and adapted for local use. The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries.",
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AU - Xavier, Denis

AU - Gupta, Rajeev

AU - Devereaux, P. J.

AU - Sigamani, Alben

AU - Hussain, Tanvir

AU - Umesh, Sowmya

AU - Xavier, Freeda

AU - Girish, Preeti

AU - George, Nisha

AU - Thomas, Tinku

AU - Chidambaram, N.

AU - Joshi, Rajnish

AU - Pais, Prem

AU - Yusuf, Salim

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N2 - Background: There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease. There are no studies from low- to middle income countries (LMICs) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease.Methods: We designed a hospital-based, open randomized trial of CHW-based interventions versus standard care. Patients after an acute coronary syndrome (ACS) were randomized to an intervention group (a CHW-based intervention package, comprising education tools to enhance self-care and adherence, and regular follow-up by the CHW) or to standard care for 12 months during which study outcomes were recorded. The CHWs were trained over a period of 6 months. The primary outcome measure was medication adherence. The secondary outcomes were differences in adherence to lifestyle modification, physiological parameters (blood pressure [BP], body weight, body mass index [BMI], heart rate, lipids), and major adverse cardiovascular events.Results: We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities. The mean age was 56.4 (±11.32) years, and 17.2% were females. A high prevalence of risk factors such as hypertension (43.4%), diabetes (31.9%), tobacco consumption (35.4%), and inadequate physical activity (70.5%) was documented. A little over half had ST-elevation myocardial infarction (53.7%), and 46.3% had non-ST-elevation myocardial infarction or unstable angina.Conclusion: The CHW interventions and training for SPREAD have been developed and adapted for local use. The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries.

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