Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot)
- Conditions
- Cardiac RehabilitationCardiovascular DiseasesSecondary Prevention
- Interventions
- Other: aktivplanOther: Usual care
- Registration Number
- NCT06025526
- Lead Sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Brief Summary
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:
* Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention?
* What is the usability, user experience and user acceptance of the aktivplan digital intervention?
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation programme phase II due to non-cardiac indication but displaying cardiovascular risk factors
- Ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection
- Agreement to attend the study follow-up visit
- Written informed consent to take part in the study
- Existing use of a digital intervention for regular heart-healthy physical activity
- Medical contraindications for incremental cycle ergometry test
- Medical contraindications for regular heart-healthy physical activity and sports
- Medical contraindications for use of a smartphone
- Inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions)
- Participation in another clinical study within the past 6 months
- Addiction or other medical conditions causing reduced decisional capacity
- Pregnant women in the third trimester
- Pregnant women in the first and second trimester with medical contraindication for physical activity and sports
- Breastfeeding women with medical contraindication for physical activity and sports
- Indication that patient is unlikely to follow study procedures (limited cooperation)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention aktivplan - Control Usual care -
- Primary Outcome Measures
Name Time Method Recruitment rate 10 weeks Number of recruits per week
Usability of the aktivplan digital intervention 10 weeks mHealth App Usability Questionnaire (MAUQ)
Technical stability of the aktivplan digital intervention 10 weeks Number and types of technical problems (qualitative data)
Use of alternative and additional strategies for supporting physical activity 10 weeks Number and types of additional strategies (qualitative data)
Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures 10 weeks Qualitative data from focus groups
Drop-out rate 10 weeks Number of drop-outs in at the 10-week follow-up visit
Adherence to the aktivplan digital intervention 10 weeks Automated usage logging of the aktivplan mobile application (Matomo platform)
Data completeness 10 weeks Percentage of missing data fields in the study database
User experience of the aktivplan digital intervention 10 weeks AttrakDiff Short Questionnaire
User acceptance of the aktivplan digital intervention 10 weeks Mobile Application Rating Scale (MARS)
Experiences and perspectives of patients regarding their study participation 10 weeks Qualitative data from semi-structured interviews
- Secondary Outcome Measures
Name Time Method Physical activity behaviour 10 weeks Moderate to vigorous physical activity (MVPA)
Weight 10 weeks Weight in kg
Blood pressure 10 weeks Blood pressure in mmHg
Exercise capacity 10 weeks Incremental cycle ergometry test
Health-related quality of life 10 weeks EQ-5D-5L Questionnaire
Exercise self-efficacy 10 weeks Exercise Self-Efficacy Scale (ESES)
Blood cholesterol 10 weeks Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio
Smoking 10 weeks Number and type of smoking products per week (qualitative data)
Patient safety 10 weeks Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form
HbA1c 10 weeks HbA1c level
Trial Locations
- Locations (2)
REHA Zentrum Salzburg
🇦🇹Salzburg, Austria
Reha-Klinik Montafon
🇦🇹Schruns, Vorarlberg, Austria