m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial

BACKGROUND: The 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. METHODS: We 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.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).