McCallum, L., Lip, S. , Rostron, M., Hanna, R., Salimin, N. B. P. M., Nichol, S. and Padmanabhan, S. (2024) OPTIMA-BP: empOwering PaTients in MAnaging Blood Pressure – protocol for a randomised parallel group study comparing use of Kvatchii web-based patient education portal as an addition to home blood pressure monitoring. Open Heart, 11(1), e002535. (doi: 10.1136/openhrt-2023-002535) (PMID:38429056)
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Abstract
Introduction: Hypertension is the leading modifiable risk factor for cardiovascular disease and is implicated in half of all strokes and myocardial infarctions. One-third of the adults in Scotland have hypertension yet only a quarter of them have their blood pressure (BP) controlled to target (<140/90 mm Hg). Empowering patients to have a better understanding of their condition and becoming actively involved in the monitoring and management of hypertension may lead to improved patient satisfaction, improved BP control and health outcomes and reduction in the use of primary/secondary care hypertension clinics. Methods and analysis: OPTIMA-BP is a randomised parallel group pilot study comparing the use of home BP monitoring accompanied by access to the web-based cardiovascular educational portal (Kvatchii) and home BP monitoring (HBPM) alone in 200 patients with hypertension attending the Glasgow Blood Pressure Clinic, Queen Elizabeth University Hospital, Glasgow. Consented participants will be asked to complete surveys on lifestyle factors, medication adherence, quality of life and hypertension knowledge, understanding and home monitoring. The intervention group will be asked to complete a survey to help evaluate the Kvatchii portal. At 6 and 12 months, the surveys will be repeated via the CASTOR EDC. Both groups will input their HBPM results at 2-month intervals into a CASTOR-EDC survey. OPTIMA-BP will follow-up with participants over 12 months with the study running over 24 months. The primary outcome is HBPM systolic BP area under the curve between baseline and 6 months Ethics and dissemination: OPTIMA-BP was approved by the North of Scotland Research Ethics Committee 2 (22/NS/0095). Current protocol version 1.2 date 6 June 2023. Written informed consent will be provided by all study participants. Study findings will be submitted to international peer-reviewed journals and will be presented at national and international scientific meetings. Trial registration number: ClinicalTrials.gov: NCT05575453. Registered 12 October 2022. https://clinicaltrials.gov/ct2/show/NCT05575453
| Item Type: | Articles |
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| Additional Information: | OPTIMA-BP is funded by NHS Greater Glasgow and Clyde Endowment Award (INGN21CA393). The funder nor sponsor has had no input into the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript. LM is supported by NHS Research Scotland Career Researcher Fellowship; SL is supported by Heart Research UK (COV22/21); SP is supported by the British Heart Foundation Centre of Excellence Award (RE/18/6/34217) and the United Kingdom Research and Innovation Strength in Places Fund (SIPF00007/1). Use of the Kvatchii portal has been provided in kind for the duration of the study. |
| Keywords: | Digital health, home blood pressure, hypertension, self-management. |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Lip, Dr Stefanie and Mccallum, Dr Linsay and Padmanabhan, Professor Sandosh and Nichol, Dr Sarah and Rostron, Dr Maggie and Hanna, Dr Rebecca |
| Authors: | McCallum, L., Lip, S., Rostron, M., Hanna, R., Salimin, N. B. P. M., Nichol, S., and Padmanabhan, S. |
| College/School: | College of Medical Veterinary and Life Sciences College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing |
| Journal Name: | Open Heart |
| Publisher: | BMJ Publishing Group |
| ISSN: | 2053-3624 |
| ISSN (Online): | 2053-3624 |
| Published Online: | 01 March 2024 |
| Copyright Holders: | Copyright © 2024 The Authors |
| First Published: | First published in Open Heart 11(1):e002535 |
| Publisher Policy: | Reproduced under a Creative Commons licence |
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Funder and Project Information
Funder and Project Information