Clinical trial NCT06025526: Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Secondary Prevention
Cardiovascular Diseases
Keywords: Digital Health
Mobile Health
Electronic health
Smartphone App
Lead sponsor: Ludwig Boltzmann Institute for Digital Health and Prevention
Sponsor class: OTHER
Collaborators: name: REHA Zentrum Salzburg
name: Reha-Klinik Montafon
First posted: 2023-09-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Recruitment rate
timeFrame: 10 weeks
measure: Drop-out rate
timeFrame: 10 weeks
measure: Data completeness
timeFrame: 10 weeks
measure: Adherence to the aktivplan digital intervention
timeFrame: 10 weeks
measure: Usability of the aktivplan digital intervention
timeFrame: 10 weeks
measure: User experience of the aktivplan digital intervention
timeFrame: 10 weeks
measure: User acceptance of the aktivplan digital intervention
timeFrame: 10 weeks
measure: Technical stability of the aktivplan digital intervention
timeFrame: 10 weeks
measure: Use of alternative and additional strategies for supporting physical activity
timeFrame: 10 weeks
measure: Experiences and perspectives of patients regarding their study participation
timeFrame: 10 weeks
measure: Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures
timeFrame: 10 weeks
Secondary outcomes:
measure: Exercise capacity
timeFrame: 10 weeks
measure: Physical activity behaviour
timeFrame: 10 weeks
measure: Weight
timeFrame: 10 weeks
measure: Blood pressure
timeFrame: 10 weeks
measure: Blood cholesterol
timeFrame: 10 weeks
measure: HbA1c
timeFrame: 10 weeks
measure: Smoking
timeFrame: 10 weeks
measure: Health-related quality of life
timeFrame: 10 weeks
measure: Exercise self-efficacy
timeFrame: 10 weeks
measure: Patient safety
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Schruns
country: Austria
facility: Reha-Klinik Montafon
state: Vorarlberg
city: Salzburg
country: Austria
facility: REHA Zentrum Salzburg
Study officials:
affiliation: Ludwig Boltzmann Institute for Digital Health and Prevention
name: Stefan T Kulnik, PhD MRes
role: STUDY_CHAIR
References: