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

October 7, 2024 updated by: Ludwig Boltzmann Institute for Digital Health and Prevention

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • REHA Zentrum Salzburg
    • Vorarlberg
      • Schruns, Vorarlberg, Austria, 6780
        • Reha-Klinik Montafon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Control
Other: Usual care
Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 10 weeks
Number of recruits per week
10 weeks
Drop-out rate
Time Frame: 10 weeks
Number of drop-outs in at the 10-week follow-up visit
10 weeks
Data completeness
Time Frame: 10 weeks
Percentage of missing data fields in the study database
10 weeks
Adherence to the aktivplan digital intervention
Time Frame: 10 weeks
Automated usage logging of the aktivplan mobile application (Matomo platform)
10 weeks
Usability of the aktivplan digital intervention
Time Frame: 10 weeks
mHealth App Usability Questionnaire (MAUQ)
10 weeks
User experience of the aktivplan digital intervention
Time Frame: 10 weeks
AttrakDiff Short Questionnaire
10 weeks
User acceptance of the aktivplan digital intervention
Time Frame: 10 weeks
Mobile Application Rating Scale (MARS)
10 weeks
Technical stability of the aktivplan digital intervention
Time Frame: 10 weeks
Number and types of technical problems (qualitative data)
10 weeks
Use of alternative and additional strategies for supporting physical activity
Time Frame: 10 weeks
Number and types of additional strategies (qualitative data)
10 weeks
Experiences and perspectives of patients regarding their study participation
Time Frame: 10 weeks
Qualitative data from semi-structured interviews
10 weeks
Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures
Time Frame: 10 weeks
Qualitative data from focus groups
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity
Time Frame: 10 weeks
Incremental cycle ergometry test
10 weeks
Physical activity behaviour
Time Frame: 10 weeks
Moderate to vigorous physical activity (MVPA)
10 weeks
Weight
Time Frame: 10 weeks
Weight in kg
10 weeks
Blood pressure
Time Frame: 10 weeks
Blood pressure in mmHg
10 weeks
Blood cholesterol
Time Frame: 10 weeks
Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio
10 weeks
HbA1c
Time Frame: 10 weeks
HbA1c level
10 weeks
Smoking
Time Frame: 10 weeks
Number and type of smoking products per week (qualitative data)
10 weeks
Health-related quality of life
Time Frame: 10 weeks
EQ-5D-5L Questionnaire
10 weeks
Exercise self-efficacy
Time Frame: 10 weeks
Exercise Self-Efficacy Scale (ESES)
10 weeks
Patient safety
Time Frame: 10 weeks
Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention

Collaborators

REHA Zentrum Salzburg
Reha-Klinik Montafon

Investigators

  • Study Chair: Stefan T Kulnik, PhD MRes, Ludwig Boltzmann Institute for Digital Health and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Actual)

July 29, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23_5 ACTIVE-CaRe Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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