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

Cardiovascular Diseases Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025526
• Other study ID #: 23_5 ACTIVE-CaRe Pilot
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Ludwig Boltzmann Institute for Digital Health and Prevention
• Contact: Stefan T Kulnik, PhD MRes
• Phone: 004357255
• Email: tino.kulnik[@]dhp.lbg.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Diseases
• Secondary Prevention

Intervention

Other:
• aktivplan
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
Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.

Locations

Country	Name	City	State
Austria	REHA Zentrum Salzburg	Salzburg
Austria	Reha-Klinik Montafon	Schruns	Vorarlberg

Sponsors (3)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute for Digital Health and Prevention	REHA Zentrum Salzburg, Reha-Klinik Montafon

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of recruits per week	10 weeks
Primary	Drop-out rate	Number of drop-outs in at the 10-week follow-up visit	10 weeks
Primary	Data completeness	Percentage of missing data fields in the study database	10 weeks
Primary	Adherence to the aktivplan digital intervention	Automated usage logging of the aktivplan mobile application (Matomo platform)	10 weeks
Primary	Usability of the aktivplan digital intervention	mHealth App Usability Questionnaire (MAUQ)	10 weeks
Primary	User experience of the aktivplan digital intervention	AttrakDiff Short Questionnaire	10 weeks
Primary	User acceptance of the aktivplan digital intervention	Mobile Application Rating Scale (MARS)	10 weeks
Primary	Technical stability of the aktivplan digital intervention	Number and types of technical problems (qualitative data)	10 weeks
Primary	Use of alternative and additional strategies for supporting physical activity	Number and types of additional strategies (qualitative data)	10 weeks
Primary	Experiences and perspectives of patients regarding their study participation	Qualitative data from semi-structured interviews	10 weeks
Primary	Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures	Qualitative data from focus groups	10 weeks
Secondary	Exercise capacity	Incremental cycle ergometry test	10 weeks
Secondary	Physical activity behaviour	Moderate to vigorous physical activity (MVPA)	10 weeks
Secondary	Weight	Weight in kg	10 weeks
Secondary	Blood pressure	Blood pressure in mmHg	10 weeks
Secondary	Blood cholesterol	Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio	10 weeks
Secondary	HbA1c	HbA1c level	10 weeks
Secondary	Smoking	Number and type of smoking products per week (qualitative data)	10 weeks
Secondary	Health-related quality of life	EQ-5D-5L Questionnaire	10 weeks
Secondary	Exercise self-efficacy	Exercise Self-Efficacy Scale (ESES)	10 weeks
Secondary	Patient safety	Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form	10 weeks