Evaluation of a digital therapy programme for the treatment of primary arterial hypertension: eXPLORE – study protocol for a fully decentralised randomised controlled feasibility study

Abstract

Introduction Hypertension is a major cause of premature death worldwide as it is an important risk factor for coronary artery disease, myocardial infarction, heart failure and stroke. Although an estimated 1.3 billion adults suffer from hypertension, less than half of them are diagnosed correctly and therefore receive sufficient treatment. Furthermore, only one fifth of those treated reach the therapy target of normotension. This significant deficit underlines the need for new therapy concepts to improve long-term health outcomes. Several studies have shown positive effects of digital health programmes in the disease management of ambulatory, long-term hypertension treatment. More research is needed to explore the abilities of digital health programmes as an innovative pathway in ambulatory healthcare.The eXPLORE study aims to evaluate the feasibility of a clinical trial on the impact of a supplementary digital therapy programme for the treatment of primary arterial hypertension.Methods and analyses The eXPLORE study collects data in the setting of a prospective randomised controlled trial to evaluate methodological feasibility for larger-scaled follow-up research. The study compares a digital therapy programme using a smartphone application that is based on functions and algorithms creating tasks and recommendations based on individual health data to standard care for the treatment of primary arterial hypertension. The study period is 180 days, with a 90-day in-life phase followed by a 90-day follow-up phase. Baseline and follow-up data (3 months, 6 months follow-up) of all participants included is collected via questionnaire surveys as well as self-administered blood pressure monitoring. Patient inclusion, initial data acquisition and follow-up were carried out in an innovative remote setting. The study was initiated in November 2022 and is currently ongoing. Study outcome measures are changes in mean blood pressure, health literacy and self-sufficient health behaviour.Ethics and dissemination The eXPLORE study is carried out in accordance with all applicable legal regulations. Cost-effectiveness is assured by continuous evaluation and documentation over the course of the study. All health-relevant data from the eXPLORE study will be provided for analyses and publication to the investigators of LMU Hospital. The study was approved by the local ethics committee of LMU Munich (project nr.: 22–0115).Trial registration NCT05580068. Protocol Version: 1.5, 28.08.2023.