Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot)

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Cardiac Rehabilitation, Secondary Prevention, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: aktivplan
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: aktivplan<br>* 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.<br>|
| Other: Control<br> | Other: Usual care<br>* Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | Incremental cycle ergometry test | 10 weeks | 
| Physical activity behaviour | Moderate to vigorous physical activity (MVPA) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital Health, Mobile Health, Electronic health, Smartphone App