Cluster randomised trial to evaluate comprehensive approach to hypertension management in Nepal: a study protocol

Abstract

IntroductionDespite having effective approaches for hypertension management including use of antihypertensive medication, monitoring of blood pressure and lifestyle modification many people with hypertension in Nepal remain undetected and untreated. A comprehensive intervention which provides personalised counselling on lifestyle modification, medication adherence together with support for regular monitoring of blood pressure is expected to achieve well controlled blood pressure.Methods and analysisThis is a community-based, non-blinded, parallel group, two-arm cluster randomised controlled trial, with an allocation ratio of 1:1, conducted in Budhanilkantha municipality, Nepal. Ten health facilities and their catchment area are randomly allocated to either of the two arms. 1250 individuals aged 18 years and older with an established diagnosis of hypertension will be recruited. The intervention arm receives a comprehensive hypertension management package that includes blood pressure audit by health workers, home-based patient support by community health workers to engage patient and family members in providing tailored educational counselling on behavioural and lifestyle changes in addition to routine care. The control arm includes routine hypertension care. Trained enumerators will ensure consent and collect data. Outcome data on blood pressure, weight, waist and hip circumference will be measured and self-reported data on diet, lifestyle, medication adherence and hypertension knowledge will be registered at 11 months’ follow-up. The change in outcome measures will be compared by intention to treat, using a generalised linear mixed model. A formative assessment will be conducted using semistructured interviews and focus group discussions to explore factors affecting hypertension management. A mix-method approach will be applied for process evaluation to explore acceptability, adoption, fidelity, feasibility and coverage.Ethics and disseminationEthics approval was obtained from Nepal Health Research Council (682/2021) and Regional Committee for Medical and Health Research Ethics, Norway (399479). The findings will be disseminated in peer-reviewed journal articles and with decision makers in Nepal.