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 health tools offer promising opportunities to support long-term behaviour change in secondary prevention. The aktivplan digital health intervention was designed for patients with CVD or increased CVD risk to establish heart-healthy physical activity routines.

Objective:

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

Methods:

This was a mixed-method pilot 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 either the aktivplan intervention or standard care without digital support. Before discharge from the rehabilitation center, participants in the intervention group were given access to the aktivplan app and a personalized prospective physical activity plan. Data were collected at baseline (T0), at discharge from the rehabilitation center (T1), and 10 weeks following discharge (T2), including clinical assessments, patient-reported outcomes, wearables for accelerometry and heart rate, and qualitative interviews. Data on intervention implementation were gathered from healthcare professionals (HCPs) through questionnaires and a focus group. 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 and perceptions of the intervention and study procedures. All analyses were descriptive.

Results:

Thirty-four participants (62% male, mean [SD] age 57 [14] years) were recruited between October 2023 and May 2024, with 16 allocated to the intervention group and 18 allocated to the control group. The average recruitment rate was one patient per week at study site one and 0.6 patients per week at study site two. Randomization resulted in equal groups with respect to sex and physical fitness. Twenty-eight out of 34 participants completed T2 (18% attrition). Data completeness was 97.4%. There were no adverse events related to the intervention or study procedures. Patient adherence to the aktivplan intervention 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. 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 digital health intervention. Clinical Trial: ClinicalTrials.gov: NCT06025526. Registered 29 August 2023 https://www.clinicaltrials.gov/search?cond=NCT06025526