Effect of a Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control in India: A Cluster Randomized Controlled Trial

Abstract

Background: Eighty percent of premature mortality from cardiovascular disease occurs in low-and middleincome countries. Hypertension, diabetes, and smoking are the top risk factors causing this disease burden. Objectives: The study aimed to test the hypothesis that utilizing community health workers (CHWs) to manage hypertension, diabetes and smoking in an integrated manner would lead to improved control of these conditions. Methods: This was a 2-year cluster (n ¼ 12) randomized controlled trial of 3,556 adults (35 to 70 years of age) in a single town in India, who were screened at home for hypertension, diabetes, and smoking. Of these adults, 1,242 (35%) had at least 1 risk factor (hypertension ¼ 650, diabetes ¼ 317, smoking ¼ 500) and were enrolled in the study. The intervention group had behavioral change communication through regular home visits from community health workers. The control group received usual care in the community. The primary outcomes were changes in systolic blood pressure, fasting blood glucose, and average number of cigarettes/ bidis smoked daily among individuals with respective risk factors. Results: The mean AE SD change in systolic blood pressure at 2 years was À12.2 AE 19.5 mm Hg in the intervention group as compared with À6.4 AE 26.1 mm Hg in the control group, resulting in an adjusted difference of e8.9 mm Hg (95% confidence interval [CI]: e3.5 to e14.4 mm Hg; p ¼ 0.001). The change in fasting blood glucose was À43.0 AE 83.5 mg/dl in the intervention group and À16.3 AE 77.2 mg/dl in the control group, leading to an adjusted difference of e21.3 mg/dl (95% CI: 18.4 to e61 mg/dl; p ¼ 0.29). The change in mean number of cigarettes/bidis smoked was nonsignificant at þ0.2 cigarettes/bidis (95% CI: 5.6 to e5.2 cigarettes/bidis; p ¼ 0.93). Conclusions: A population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking. (Study of a Community-Based Approach to Control Cardiovascular Risk Factors in India [SEHAT]; NCT02115711).

Observational stepped-wedge analysis of a community health worker-led intervention for diabetes and hypertension in rural Mexico

“…Our results are consistent with the growing literature of LMICs supporting the role of CHWs in improving cardiovascular disease risk 10 12–15. Our study differs from many existing studies conducted among patients with newly diagnosed or uncontrolled disease in that we implemented the intervention in a population that included both controlled and uncontrolled patients already on pharmacologic treatment.…”

“…Our study differs from many existing studies conducted among patients with newly diagnosed or uncontrolled disease in that we implemented the intervention in a population that included both controlled and uncontrolled patients already on pharmacologic treatment. The 10 mm Hg reduction in SBP we observed among patients with uncontrolled hypertension is on par with recent cluster-randomised trials from India (−8.9 mm Hg),10 Argentina (−6.6 mm Hg),13 Colombia and Malaysia (−11.5 mm Hg) 15. Our study further adds to the literature by supporting the role for CHWs in patients with diabetes, where studies have produced promising but sometimes inconclusive results 8–10…”

“…A recent systematic review of CHWs in LMICs for prevention and management of diabetes found positive outcomes in a majority of studies, but identified significant heterogeneity among structures of CHW interventions and limitations due to study design, high rates of attrition, absence of detailed reporting on operational design and variable programme fidelity 7. Observational studies of CHW-led interventions demonstrated improvement in fasting plasma glucose,8 9 though a recent cluster-randomised trial found inconclusive results, potentially due to a lack of power 10. For cardiovascular disease, two systematic reviews, including one meta-analysis of randomised trials, identified improvements in blood pressure with CHW interventions 4 11.…”

“…For cardiovascular disease, two systematic reviews, including one meta-analysis of randomised trials, identified improvements in blood pressure with CHW interventions 4 11. Several recent cluster-randomised trials around the world demonstrated blood pressure reduction and improved cardiovascular risk control among patients with uncontrolled hypertension 10 12–15. Variability in findings across studies could result from heterogeneity in CHW interventions, including CHW roles, which may include disease screening, individual or group disease education, lifestyle management, medication and clinic adherence support and medication management—with or without assistance of clinic physicians.…”

Health system interventions for adults with type 2 diabetes in low- and middle-income countries: A systematic review and meta-analysis

“…Diabetes education or support alone. Nine studies involved health workers primarily implementing diabetes education or support without additional services [32,39,40,43,46,49,53,54,56]. We defined these interventions as diabetes education or support alone.…”