PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform

Abstract

IntroductionExercise-based cardiac rehabilitation (CR) independently alters the clinical course of cardiovascular diseases resulting in a significant reduction in all-cause and cardiac mortality. However, only 15%–30% of all eligible patients participate in a phase 2 ambulatory programme. The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor. Newer care models, involving telerehabilitation programmes that are delivered remotely, show considerable promise for increasing adherence. In this view, the PATHway (Physical Activity Towards Health) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy.Methods and analysisIn a multicentre randomised controlled pilot trial, 120 participants (m/f, age 40–80 years) completing a phase 2 ambulatory CR programme will be randomised on a 1:1 basis to PATHway or usual care. PATHway involves a comprehensive, internet-enabled, sensor-based home CR platform and provides individualised heart rate monitored exercise programmes (exerclasses and exergames) as the basis on which to provide a personalised lifestyle intervention programme. The control group will receive usual care. Study outcomes will be assessed at baseline, 3 months and 6 months after completion of phase 2 of the CR programme. The primary outcome is the change in active energy expenditure. Secondary outcomes include cardiopulmonary endurance capacity, muscle strength, body composition, cardiovascular risk factors, peripheral endothelial vascular function, patient satisfaction, health-related quality of life (HRQoL), well-being, mediators of behaviour change and safety. HRQoL and healthcare costs will be taken into account in cost-effectiveness evaluation.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the director and clinical director of the PATHway study and by the ethical committee of each participating site. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses and events.Trial registration numberNCT02717806. This trial is currently in the pre-results stage.

Cardiac rehabilitation and physical activity: systematic review and meta-analysis

“…For example, the ongoing PATHway I trial, where the basis of the CR intervention is PA promotion and the primary outcome is objectively measured PA level. 39 …”

The development and codesign of the PATHway intervention: a theory-driven eHealth platform for the self-management of cardiovascular disease

“…For further details on the intervention see Additional file 4 where the Template for Intervention Description and Replication (TIDieR) checklist is reported to ensure the completeness of reporting, and ultimately the replicability, of interventions [40]. For further details on validated tools/questionnaires used within the intervention please see the PATHway RCT protocol [41].…”

A qualitative exploration of cardiovascular disease patients’ views and experiences with an eHealth cardiac rehabilitation intervention: The PATHway Project

“…Patients participating in outpatient CR were invited during the last four weeks of outpatient CR to take part in the trial. Written informed consent was obtained and participants were then randomized to either the intervention group (PATHway) or the control group (usual care) [10]. A detailed description of the PATHway-I trial and quantitative results can be found elsewhere [10,13].…”

“…Written informed consent was obtained and participants were then randomized to either the intervention group (PATHway) or the control group (usual care) [10]. A detailed description of the PATHway-I trial and quantitative results can be found elsewhere [10,13]. In brief, one hundred and twenty participants were recruited across three sites in two countries: The Mater Misericordiae University Hospital (Dublin), Beaumont Hospital (Dublin) and University Hospital Leuven (UZ Leuven, Belgium).…”

“…A mixed methods randomized controlled multicenter trial was undertaken to evaluate the acceptability, feasibility and clinical effectiveness of an eHealth phase 3 CR intervention: Physical Activity Towards Health (PATHway) [10]. PATHway is a personalized, lifestyle intervention which uses an integrated behaviour change approach with an internet-enabled and sensor-based home exercise platform as the core component.…”