Addressing Hypertension Care in Africa (ADHINCRA): Study protocol for a cluster-randomized controlled pilot trial.

BACKGROUND: Uncontrolled hypertension is a major risk factor for cardiovascular disease. Evidence-based interventions to improve hypertension control in high-income countries have not been translated equally in sub-Saharan Africa (SSA). The objective of the Addressing Hypertension Care in Africa (ADHINCRA) Study was to test the feasibility and signal of efficacy of a multilevel, nurse-led, mobile health enhanced intervention in improving hypertension control in Ghana. METHODS: Using a cluster randomized controlled pilot trial design, four hospitals in Kumasi, Ghana, were randomized to the intervention arm (2 hospitals) and enhanced usual care arm (2 hospitals). A total of 240 patients with uncontrolled hypertension defined as systolic blood pressure (BP) ≥140 mmHg on their most recent visit were included (60 patients per hospital). Patients in the intervention arm received an intervention that consisted of nurse-led task-shifting and a mobile health application (Medtronic® Labs' Empower Health), and home BP monitoring. The enhanced usual care arm received usual care as determined by their providers, plus short text messages on health. The intervention was administered for six months, after which it was withdrawn, and patients were followed for six more months to assess outcomes. Feasibility measures included recruitment and dropout rates of study participants, protocol adherence in both arms. Clinical outcomes included changes in BP control status and systolic BP levels from baseline. Secondary outcomes included change in glycemic control, rates of hypertensive urgencies/emergencies, cardiovascular disease events, and medication adherence. DISCUSSION: Findings from this study will provide critical pilot data to inform the conduct of a larger scale trial and the development of scalable health system and policy interventions to improve hypertension control in low-resource settings. Trial registration NCT04010344. Registered on July 8, 2019 at ClinicalTrials.govhttps://clinicaltrials.gov/ct2/show/NCT04010344.

Improved blood pressure control via a novel chronic disease management model of care in sub-Saharan Africa: Real-world program implementation results.

A chronic disease management model of care (Empower Health) was launched in rural and urban areas of Ghana and Kenya in 2018. The goal was to improve disease awareness, reduce the burden of disease, and improve the clinical effectiveness and efficiency of managing hypertension. Leveraging the model, clinicians provide patients with tailored management plans. Patients accessed regular blood pressure checks at home, at the clinic, or at community-partner locations where they received real-time feedback. On the mobile application, clinicians viewed patient data, provided direct patient feedback, and wrote electronic prescriptions accessible through participating pharmacies. To date, 1266 patients had been enrolled in the "real-world" implementation cohort and followed for an average of 351 ± 133 days across 5 facilities. Average baseline systolic blood pressure (SBP) was 145 ± 21 mmHg in the overall cohort and 159 ± 16 mmHg in the subgroup with uncontrolled hypertension (n = 743) as defined by baseline SBP ≥ 140 mmHg. SBP decreased significantly through 12 months in both the overall cohort (-9.4 mmHg, p < .001) and in the uncontrolled subgroup (-17.6 mmHg, p < .001). The proportion patients with controlled pressure increased from 46% at baseline to 77% at 12 months (p < .001). In summary, a new chronic disease management model of care improved and sustained blood pressure control to 12 months, especially in those with elevated blood pressure at enrollment.