JMIR Publications

ABSTRACT

Background:

Patients with cardiovascular disease (CVD) often struggle to develop and maintain heart-healthy physical activity habits, even after completing a cardiac rehabilitation program. Digital tools offer opportunities to support long-term behavior change in secondary prevention. The aktivplan digital health intervention (DHI) was designed to help these patients establish heart-healthy physical activity routines.

Objective:

To evaluate the feasibility of a randomized controlled trial design to assess the effectiveness of the aktivplan DHI for patients with CVD or increased CVD risk.

Methods:

This was a pilot feasibility study with a two-arm, parallel-group, non-blinded randomized controlled design. Patients admitted at two phase II rehabilitation centers in Austria were screened. Eligible were patients admitted for cardiac rehabilitation, as well as non-cardiac rehabilitation patients with increased cardiovascular risk. Recruited patients were randomly assigned to the aktivplan intervention or standard care without digital support. Before discharge from the rehabilitation center, the intervention group was given access to the aktivplan app and a personalized prospective physical activity plan. Data collected at baseline, discharge from the rehabilitation center, and 10 weeks following discharge, included clinical assessments, patient-reported outcomes, wearables for accelerometry and heart rate. All patients gave qualitative interviews. Data on intervention implementation were gathered from all healthcare professionals (HCPs) through questionnaires and focus group. The qualitative data analysis was conducted according to the framework analysis method. Feasibility outcomes included recruitment rate, attrition, data completeness, adverse events, patient adherence to the aktivplan intervention, fidelity of intervention delivery regarding shared decision-making by HCPs, and both patients' and HCPs' experiences of the intervention and study procedures. All analyses were descriptive.

Results:

: During the study period from October 2023 to August 2024, 34 participants (62% male, mean [SD] age 57 [14] years) were recruited. Sixteen were allocated to the intervention group, and 18 to the control group. At study sites one and two, the average recruitment rate was 1.0 and 0.6 patients per week, respectively. Randomization resulted in equal groups with respect to sex and physical fitness. Attrition was 18%, data completeness was 97.4%, and there were no adverse events related to the intervention or study procedures. Patient adherence was high, with 71% of planned physical activities completed and mean (SD) 39 (38) additional physical activity sessions per participant. Participants and HCPs were generally supportive about the intervention and the study procedures, providing positive feedback and helpful suggestions for improvement of design and intervention. HCPs felt that the intervention was implemented effectively (Normalization Measure Development Questionnaire mean [SD] score 3.75 [0.50], scale 1-5, higher score indicating better implementation).

Conclusions:

This pilot study generated valuable data to inform the design of a future definitive effectiveness trial of the aktivplan DHI, including strategies for optimizing recruitment and acceptability of the intervention. Clinical Trial: ClinicalTrials.gov: NCT06025526. Registered 29 August 2023 https://www.clinicaltrials.gov/search?cond=NCT06025526