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 middle-income 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 = 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 = 650, diabetes = 317, smoking = 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 ± SD change in systolic blood pressure at 2 years was -12.2 ± 19.5 mm Hg in the intervention group as compared with -6.4 ± 26.1 mm Hg in the control group, resulting in an adjusted difference of -8.9 mm Hg (95% confidence interval [CI]: -3.5 to -14.4 mm Hg; p = 0.001). The change in fasting blood glucose was -43.0 ± 83.5 mg/dl in the intervention group and -16.3 ± 77.2 mg/dl in the control group, leading to an adjusted difference of -21.3 mg/dl (95% CI: 18.4 to -61 mg/dl; p = 0.29). The change in mean number of cigarettes/bidis smoked was nonsignificant at +0.2 cigarettes/bidis (95% CI: 5.6 to -5.2 cigarettes/bidis; p = 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).

Conflict of interest statement

The authors report no relationships that could be construed as a conflict of interest.

Copyright © 2019 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.

Figures

FIGURE 1.. Intervention timeline.

CHWs = community health workers; CME = continuing medical education.

FIGURE 2.. Study flow diagram.

Twelve clusters (6 in the intervention arm, 6 in the control arm) were randomly selected from a total of 36 clusters. Screening commenced after randomization. DM = diabetes; HTN = hypertension.

FIGURE 3.. (A) Number of antihypertensive medications used by study group.

Only individuals available for follow-up at the end of 2 years were analyzed (intervention group = 341 participants, control group = 186 participants). The percentage of participants on 0 drugs decreased from 60% at baseline to 39% at the end of 2 years in the intervention group (difference of −21%), while in the control group it decreased from 67% to 63% (difference of −4%). Correspondingly, the percentage of participants on ≥ 2 drugs increased from 10% to 18% (difference of 8%) in the intervention group, while in the control group it increased from 10% to 12% (difference of 2%). (B) Number of antihyperglycemic medications used by study group. Only individuals available for follow-up at the end of 2 years were analyzed (intervention group 178 participants, control group 62 participants). The percentage of participants on 0 drugs decreased from 37% at baseline to 26% at the end of 2 years in the intervention group (difference of −11%) while in the control group it decreased from 47% to 42% (difference of −5%). Correspondingly, the percentage of participants on ≥2 drugs increased from 34% to 51% (difference of 17%) in the intervention group, while in the control group it increased from 24% to 29% (difference of 5%).