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| Name | Class |
|---|---|
| REHA Zentrum Salzburg | UNKNOWN |
| Reha-Klinik Montafon | UNKNOWN |
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The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients.
The main questions this study aims to answer are:
Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation.
Patients in the intervention group will be given the aktivplan application (app) on their smartphone. A rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. The patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions.
Patients in the control group will receive the usual standard of care without the aktivplan digital intervention.
Researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aktivplan | Other | The aktivplan digital intervention consists of a digital planning calendar for regular heart-healthy physical activity Towards the end of rehabilitation phase II, health professionals introduce aktivplan and plan a personalised physical activity plan together with their patients using shared decision-making. The physical activity plan is devised for the time after discharge from cardiac rehabilitation. In the aktivplan smatphone app, the patient can view their personalised physical activity plan, check off completed activities, enter additional unplanned activities, and open short videos with exercise instructions. Additional functions of aktivplan include patient-centered goal-setting, automated messages to the patient (motivational messages and reminders), and the possibility for health professionals to monitor all their patients' adherence to the physical activity plan and to contact individual patients directly via the app. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of recruits per week | 10 weeks |
| Drop-out rate | Number of drop-outs in at the 10-week follow-up visit | 10 weeks |
| Data completeness | Percentage of missing data fields in the study database | 10 weeks |
| Adherence to the aktivplan digital intervention | Automated usage logging of the aktivplan mobile application (Matomo platform) | 10 weeks |
| Usability of the aktivplan digital intervention | mHealth App Usability Questionnaire (MAUQ) | 10 weeks |
| User experience of the aktivplan digital intervention | AttrakDiff Short Questionnaire | 10 weeks |
| User acceptance of the aktivplan digital intervention | Mobile Application Rating Scale (MARS) | 10 weeks |
| Technical stability of the aktivplan digital intervention | Number and types of technical problems (qualitative data) | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Incremental cycle ergometry test | 10 weeks |
| Physical activity behaviour | Moderate to vigorous physical activity (MVPA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan T Kulnik, PhD MRes | Ludwig Boltzmann Institute for Digital Health and Prevention | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| REHA Zentrum Salzburg | Salzburg | State of Salzburg | 5020 | Austria | ||
| Reha-Klinik Montafon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953438 | Derived | Leysen D, Reich B, Carrozzo AE, Crutzen R, Grote V, Kumar D, Mayr B, Niebauer J, Pfannerstill F, Propst EM, Wurhofer D, Sareban M, Smeddinck JD, Treff G, Kulnik ST. 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). JMIR Res Protoc. 2025 Sep 15;14:e73704. doi: 10.2196/73704. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| Usual care | Other | Usual care (standard of care) according to international and national cardiac rehabilitation guidelines. |
|
| Use of alternative and additional strategies for supporting physical activity |
Number and types of additional strategies (qualitative data) |
| 10 weeks |
| Experiences and perspectives of patients regarding their study participation | Qualitative data from semi-structured interviews | 10 weeks |
| Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures | Qualitative data from focus groups | 10 weeks |
| 10 weeks |
| Weight | Weight in kg | 10 weeks |
| Blood pressure | Blood pressure in mmHg | 10 weeks |
| Blood cholesterol | Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio | 10 weeks |
| HbA1c | HbA1c level | 10 weeks |
| Smoking | Number and type of smoking products per week (qualitative data) | 10 weeks |
| Health-related quality of life | EQ-5D-5L Questionnaire | 10 weeks |
| Exercise self-efficacy | Exercise Self-Efficacy Scale (ESES) | 10 weeks |
| Patient safety | Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form | 10 weeks |
| Schruns |
| Vorarlberg |
| 6780 |
| Austria |