Journal Article

Participative research for individualised care in cardiovascular diseases (PRIC-CVD): study protocol for a non-interventional, multicentre mixed-methods study as part of iCARE4CVD

Baldewijns, Karolien, Brunner-La Rocca, Hans-Peter, Hill, Loreena, Helms, Thomas Maria, Romero, Iñaki, Steiner, Bianca, McNulty, Anne, Schwertfeger, Markus, Zippel-Schultz, Bettina, Barrett, Matthew, Verket, Marlo, Brandts, Julia, Friedl, Sabine, Murphy, Marguerite

2025

Overview

IntroductionCardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.Methods and analysisParticipative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.Ethics and disseminationThis study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.Trial registration numberDRKS00034899.Protocol versionV2.1, 6 June 2024.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Cardiovascular Disease / Cardiovascular Diseases - prevention & control / Cardiovascular Diseases - therapy / Cardiovascular medicine / Clinical Protocols / Delphi method / Diabetes / eHealth / Europe / Focus groups / Germany / Health risks / Health surveys / Heart failure / Humans / Hypertension / Inclusion / Interdisciplinary aspects / Intervention / Medical research / Metabolic disorders / Mixed methods research / Morbidity / Mortality / Multicenter Studies as Topic / Non-pharmacological intervention / Participation / Patient Participation / Patient Reported Outcome Measures / Patients / Precision Medicine - methods / Public health / Research Design / Self Care