An interventional study of aktivplan and Usual care in Cardiac Rehabilitation, Secondary Prevention and Cardiovascular Diseases, sponsored by Ludwig Boltzmann Institute for Digital Health and Prevention. Completed at 2 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Ludwig Boltzmann Institute for Digital Health and Prevention · Not applicable, Interventional, and Treatment
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Ludwig Boltzmann Institute for Digital Health and Prevention is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: aktivplan
Other: Usual care
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.
Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.
Recruitment rate
Number of recruits per week
Time frame: 10 weeks
Drop-out rate
Number of drop-outs in at the 10-week follow-up visit
Time frame: 10 weeks
Data completeness
Percentage of missing data fields in the study database
Time frame: 10 weeks
Adherence to the aktivplan digital intervention
Automated usage logging of the aktivplan mobile application (Matomo platform)
Time frame: 10 weeks
Usability of the aktivplan digital intervention
mHealth App Usability Questionnaire (MAUQ)
Time frame: 10 weeks
User experience of the aktivplan digital intervention
AttrakDiff Short Questionnaire
Time frame: 10 weeks
User acceptance of the aktivplan digital intervention
Mobile Application Rating Scale (MARS)
Time frame: 10 weeks
Technical stability of the aktivplan digital intervention
Number and types of technical problems (qualitative data)
Time frame: 10 weeks
Use of alternative and additional strategies for supporting physical activity
Number and types of additional strategies (qualitative data)
Time frame: 10 weeks
Experiences and perspectives of patients regarding their study participation
Qualitative data from semi-structured interviews
Time frame: 10 weeks
Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures
Qualitative data from focus groups
Time frame: 10 weeks
Exercise capacity
Incremental cycle ergometry test
Time frame: 10 weeks
Physical activity behaviour
Moderate to vigorous physical activity (MVPA)
Time frame: 10 weeks
Weight
Weight in kg
Time frame: 10 weeks
Blood pressure
Blood pressure in mmHg
Time frame: 10 weeks
Blood cholesterol
Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio
Time frame: 10 weeks
HbA1c
HbA1c level
Time frame: 10 weeks
Smoking
Number and type of smoking products per week (qualitative data)
Time frame: 10 weeks
Health-related quality of life
EQ-5D-5L Questionnaire
Time frame: 10 weeks
Exercise self-efficacy
Exercise Self-Efficacy Scale (ESES)
Time frame: 10 weeks
Patient safety
Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form
Time frame: 10 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Ludwig Boltzmann Institute for Digital Health and Prevention