JMIR Publications

ABSTRACT

Background:

Patients with cardiovascular disease (CVD) often encounter challenges in establishing and maintaining heart-healthy physical activity habits, even after successfully completing a cardiac rehabilitation programme. Digital health technologies hold promise to support long-term habit formation in the secondary prevention of CVD. The aktivplan digital health intervention has been developed to support patients with CVD in establishing long-term heart-healthy physical activity habits.

Objective:

The primary study objective is to pilot and assess the feasibility of a randomised controlled trial design to investigate the effectiveness of the aktivplan intervention; and to assess the usability, user experience and acceptance of the intervention. The secondary objective is to collect clinical and safety outcomes.

Methods:

This multi-centre, randomised controlled pilot study aims to recruit 40 patients with an established diagnosis of CVD or with increased risk of CVD (physically inactive plus one further CVD risk factor) who are undergoing phase II rehabilitation at two rehabilitation centres in Austria. Participants will be allocated to the intervention or standard care control group by stratified randomisation and will be monitored for 10 weeks after discharge from phase II rehabilitation. Participants, healthcare professionals, and outcome assessors are not masked (blinded) to group allocation. Data collection includes recruitment and drop-out rate; data completeness; adherence to the intervention; usability, user experience, and user acceptance questionnaires; technical reliability of the intervention; clinical assessments (exercise capacity, physical activity behaviour, CVD risk factors); adverse events; self-reported outcome measures (health-related quality of life, exercise self-efficacy, depression and anxiety, kinesiophobia); as well as patient interviews and focus groups with healthcare professionals. Quantitative data will be analysed descriptively, and 95% confidence intervals will be calculated for recruitment and drop-out rates and for data completeness. No confirmatory inferential statistical analysis or hypothesis testing will be conducted. Qualitative data will be analysed thematically by framework analysis.

Results:

A total of 34 participants were recruited between October 2023 and May 2024. Data collection was completed in August 2024. Currently, the data is being analysed and prepared for publication. The first publication of feasibility results is expected for summer 2025.

Conclusions:

This pilot study is expected to generate valuable and comprehensive insights to inform the study design of a future definitive effectiveness trial of the aktivplan intervention, guide the need for further iteration of aktivplan prior to entering a definitive trial, and inform future implementation strategies for the intervention. Clinical Trial: ClinicalTrials.gov: NCT06025526. Registered 29 August 2023 https://www.clinicaltrials.gov/search?cond=NCT06025526