Trial Name
HOME BP - Home & Online Management & Evaluation of Blood Pressure
Description
HOME-BP is a digital intervention for the self-management of high blood pressure, consisting of self-monitoring of blood pressure, health professional directed and supervised titration of anti-hypertensive medication and optional user-selected lifestyle modifications, for people with uncontrolled essential hypertension. Participants will be individually randomised either to the HOME-BP programme with optional nurse support or to a control group receiving usual hypertension care. This trial will be coordinated from UK facilitated by the PCRN’s in these areas with researchers and research nurses employed at each centre.
Objectives
Primary Objective:
- Does the web-based HOME-BP programme to assist self-monitoring and self-management of uncontrolled hypertension result in greater control of blood pressure?
Secondary Objectives:
- Is the HOME-BP programme a cost-effective method for managing poorly controlled hypertension in primary care?
- Which factors are related to patient engagement and adherence to the HOME BP programme?
Tertiary Objectives:
- Is the HOME-BP programme acceptable to patients when integrated into routine practice?
- What are patient and health care practitioner views and experiences of the HOME-BP programme and its integration into primary care for the self-management of poorly controlled hypertension?
Design
Individually randomised phase 2/3 controlled trial (assessor blinded), the HOME-BP study will comprise:
- Internal pilot trial: 60 participants (30 per arm) will be recruited from practices to confirm the acceptability and feasibility of the intervention, full trial protocol and study procedures.
- Randomised controlled trial: A full randomised controlled trial will compare blood pressure management using the HOME-BP programme with nurse support to usual NHS care for patients with uncontrolled hypertension. A total of 574 participants will be recruited, 287 per arm.
- Health economic modelling and a qualitative process analysis study will also be embedded in to the HOME-BP study.
Population
Adult patients with uncontrolled hypertension (>140/90 mmHg at baseline ), who are currently receiving medication for hypertension control. Patients must also have access to the internet and be able to use and comprehend the website.
Contacts
Sponsor: University of Southampton
Chief Investigator: Prof Lucy Yardley
Clinical Trial Coordinator: Jo Kelly
Email: homebp@soton.ac.uk