ArticleJMIR research protocols2025
Feasibility of the aktivplan Digital Health Intervention for Regular Physical Activity Following Phase II Rehabilitation: Protocol for a Mixed Method Randomized Controlled Pilot Study (ACTIVE-CaRe Pilot).
Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06025526 (Effectiveness of the Aktivplan Digital Intervention for Supporting Regular Heart-healthy Levels of Physical Activity Following Completion of a Phase II Rehabilitation Programme), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effectiveness of the Aktivplan Digital Intervention for Supporting Regular Heart-healthy Levels of Physical Activity Following Completion of a Phase II Rehabilitation Programme: a Clinical Pilot Study
Who cites it
2 citing papers in PubMed.
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with cardiovascular disease (CVD) often encounter challenges in establishing and maintaining heart-healthy physical activity habits, even after successfully completing a cardiac rehabilitation program. 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.
objectiveThe primary study aim is to pilot and assess the feasibility of a future randomized controlled trial design to investigate the effectiveness of the aktivplan intervention and to assess the usability, user experience, and acceptance of the aktivplan app. The secondary objective is to collect clinical and safety outcomes.
methodsThis multicenter, mixed method, randomized controlled pilot study aims to recruit 40 patients with an established diagnosis of CVD or with increased risk of CVD (physically inactive along with 1 further CVD risk factor) who are undergoing phase II rehabilitation at 2 rehabilitation centers in Austria. Participants will be allocated to the intervention or standard care control group by stratified randomization and will be monitored for 10 weeks after discharge from phase II rehabilitation. Participants, health care professionals, and outcome assessors are not masked (blinded) to group allocation. Data collection will include 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 behavior, and CVD risk factors); adverse events; self-reported outcome measures (health-related quality of life, exercise self-efficacy, depression and anxiety, and kinesiophobia); patient interviews, and focus groups with health care professionals. Quantitative data will be analyzed descriptively, and 95% CIs 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 analyzed thematically by framework analysis.
resultsA total of 34 participants were recruited between October 2023 and May 2024. Data collection was completed in August 2024. Currently, the data are being analyzed and prepared for publication. The first publication of feasibility results is expected by summer 2025.
conclusionsThis 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 the aktivplan app before entering a definitive trial, and inform future implementation strategies for the intervention.
trial registrationClinicalTrials.gov NCT06025526; https://clinicaltrials.gov/study/NCT06025526. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73704.
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