Feasibility of a randomised controlled trial of the aktivplan digital intervention for regular physical activity following phase II rehabilitation: the ACTIVE-CaRe Pilot study

Background Patients with cardiovascular disease (CVD) or increased CVD risk often encounter challenges in maintaining physical activity (PA) as a component of lifestyle change, even after rehabilitation. Digital health interventions (DHIs) can support behaviour change and long-term adherence to PA. The aktivplan DHI [1] has been developed to support patients in establishing lifelong PA habits. Purpose This study aimed to evaluate the feasibility of a randomised controlled trial (RCT) design to investigate the effectiveness of aktivplan for patients with CVD or increased CVD risk compared to standard care. Feasibility outcomes were recruitment, retention, data completeness, patient safety and intervention implementation. Methods This was a multicentre two-arm parallel-group non-blinded RCT. Two rehabilitation centres (one inpatient, one outpatient) in Austria screened patients admitted to phase II rehabilitation against study eligibility criteria. Eligible were patients admitted for cardiac rehabilitation and patients with non-cardiac rehabilitation who had increased CVD risk (physical inactivity plus additional CVD risk factors). Patients were recruited and randomised to the intervention (aktivplan) or standard care (no digital support). Random allocation was concealed and stratified according to study site, sex, and physical fitness. Prior to discharge from rehabilitation, participants in the intervention group received the aktivplan app with personalised prospective PA plan (figure 1). Data collection from participants at baseline (T0), discharge from rehabilitation (T1), and 10-week follow-up (T2) included clinical assessments, patient-reported outcome measures, accelerometry and wearable heart rate sensors, and qualitative interviews. Intervention implementation measures included questionnaires and focus groups with rehabilitation staff. Data were analysed descriptively. Results Figure 2 shows the CONSORT flow diagram. Thirty-four participants (62% male, mean [SD] age 57 [14] years) were recruited between October 2023 and May 2024. Average recruitment rate was 1.6 patients per week. Randomisation resulted in equal groups in terms of sex and physical fitness, but the intervention group was, on average, nine years younger. Data collection was completed in July 2024, with 28 out of 34 participants completing T2 (17.6% attrition). Data completeness was good (2.6% missing data). There were no adverse events related to intervention or study procedures. Rehabilitation staff found that the intervention was implemented well (Normalisation Measure Development Questionnaire mean [SD] score 36/52 [6], self-efficacy for intervention delivery mean [SD] score 20/27 [3]). Participants gave positive ratings for the aktivplan app (AttrakDiff Short questionnaire mean [SD] score 1.75 [0.9] on a scale from -3 to 3). Conclusion This pilot study confirms the feasibility of the RCT design and enables a future definitive effectiveness trial of the aktivplan DHI.