Abstract
BackgroundThe proportion of patients with controlled hypertension (< 140/90 mmHg) is very low in India. Thus, there is a need to improve blood pressure management among patients with uncontrolled hypertension through innovative strategies directed at health system strengthening.MethodsWe designed an intervention consisting of two important components – an electronic decision support system (EDSS) used by a trained nurse care coordinator (NCC). Based on preliminary data, we hypothesized that this intervention will be able to reduce mean systolic blood pressure by 6.5 mmHg among those with uncontrolled blood pressure in the intervention arm compared to the standard treatment arm (paper-based hypertension treatment guidelines). The study will adopt a cluster randomized trial design with the community health center (CHC) as the unit of randomization. The trial will be conducted in Visakhapatnam district (southern India). A total of 1876 participants aged ≥30 years with high blood pressure – systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg will be enrolled from 12 CHCs. The intervention consists of trained NCCs equipped with an evidence-based hypertension treatment algorithm in the form of the EDSS with regular SMSs to patients with hypertension to promote hypertension treatment and blood pressure control for 12 months. The primary outcome will be difference in the mean change of SBP, from baseline to 12 months, between the intervention and the standard treatment arm. The secondary outcomes are the difference in mean change of DBP; difference in the proportion of patients with controlled blood pressure (< 140/90 mmHg); difference in mean change of fasting blood sugar, HbA1C, eGFR, and albumin to creatinine ratio; difference in the proportion of patients visiting the CHC regularly (number of actual visits to the CHC/number of visits suggested by the EDSS > 80%); difference in proportion of patients compliant to anti-hypertensive medication/s; cost-effectiveness of intervention versus enhanced care. All the outcomes will be assessed at 12 months.DiscussionThe study is expected to provide evidence on the effectiveness of NCC-led, EDSS-based hypertension management in India and can likely offer an exemplar for improving cardiovascular disease (CVD) management in India within the resource-constrained public healthcare system.Trial registrationClinicalTrials.gov, ID: NCT03164317). Registered retrospectively on 23 May 2017 (first patient enrolled on 6 April 2017) because the authors did not receive a response to their original registration submission (5 January 2017) to the Clinical Trial Registry – India (CTRI).
Highlights
The proportion of patients with controlled hypertension (< 140/90 mmHg) is very low in India
Three previous studies in primary care settings of India have demonstrated the effectiveness of the mHealth intervention [7, 20, 21]
In the study by Anchala et al [20], the decision support system was managed by the physicians and there were no nurse care coordinator (NCC) to support them
Summary
Trial design The study will be a parallel-group, cluster randomized trial to test the effectiveness of a trained NCC-led intervention by comparing with usual care. The physicians will be provided with paper-based current evidence-based management guidelines The physicians in both the arms will receive refresher training on hypertension management prior to the randomization of CHCs. Difference in the mean change of SBP, from baseline to 12 months, between the intervention and enhanced care arms. Sample size The sample size has been calculated based on the following – significance at 5%, power of 80%, mean difference in SBP of 6.5 mmHg between the intervention and standard treatment arms, standard deviation (SD) of SBP of 17, intracluster coefficient of 0.03 (estimated from the baseline study of a comprehensive diabetes and hypertension prevention and management program entitled UDAY in Visakhapatnam) and attrition rate of 20%. Electronic, and social media will be utilized to share the results to non-specialist audiences
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