Skip to main content
OpenTrials
Completed

NCT Number: NCT06025526

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Rehabilitation Cardiovascular Diseases Secondary Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REHA Zentrum Salzburg, Salzburg, State of Salzburg, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

aktivplan

Other

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

Other

Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.

Primary outcomes

  1. Recruitment rate

    Time frame: 10 weeks

    Number of recruits per week

  2. Drop-out rate

    Time frame: 10 weeks

    Number of drop-outs in at the 10-week follow-up visit

  3. Data completeness

    Time frame: 10 weeks

    Percentage of missing data fields in the study database

  4. Adherence to the aktivplan digital intervention

    Time frame: 10 weeks

    Automated usage logging of the aktivplan mobile application (Matomo platform)

  5. Usability of the aktivplan digital intervention

    Time frame: 10 weeks

    mHealth App Usability Questionnaire (MAUQ)

  6. User experience of the aktivplan digital intervention

    Time frame: 10 weeks

    AttrakDiff Short Questionnaire

  7. User acceptance of the aktivplan digital intervention

    Time frame: 10 weeks

    Mobile Application Rating Scale (MARS)

  8. Technical stability of the aktivplan digital intervention

    Time frame: 10 weeks

    Number and types of technical problems (qualitative data)

  9. Use of alternative and additional strategies for supporting physical activity

    Time frame: 10 weeks

    Number and types of additional strategies (qualitative data)

  10. Experiences and perspectives of patients regarding their study participation

    Time frame: 10 weeks

    Qualitative data from semi-structured interviews

  11. Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures

    Time frame: 10 weeks

    Qualitative data from focus groups

Secondary outcomes

  1. Exercise capacity

    Time frame: 10 weeks

    Incremental cycle ergometry test

  2. Physical activity behaviour

    Time frame: 10 weeks

    Moderate to vigorous physical activity (MVPA)

  3. Weight

    Time frame: 10 weeks

    Weight in kg

  4. Blood pressure

    Time frame: 10 weeks

    Blood pressure in mmHg

  5. Blood cholesterol

    Time frame: 10 weeks

    Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio

  6. HbA1c

    Time frame: 10 weeks

    HbA1c level

  7. Smoking

    Time frame: 10 weeks

    Number and type of smoking products per week (qualitative data)

  8. Health-related quality of life

    Time frame: 10 weeks

    EQ-5D-5L Questionnaire

  9. Exercise self-efficacy

    Time frame: 10 weeks

    Exercise Self-Efficacy Scale (ESES)

  10. Patient safety

    Time frame: 10 weeks

    Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form

Sponsors and collaborators

Lead sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention

Other

Collaborators

  • REHA Zentrum Salzburg
  • Reha-Klinik Montafon

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 6, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.