NCT06025526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

August 23, 2023

Last Update Submit

October 7, 2024

Conditions

Cardiac RehabilitationSecondary PreventionCardiovascular Diseases

Keywords

Digital HealthMobile HealthElectronic healthSmartphone App

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (10)

  • Exercise capacity

    10 weeks

  • Physical activity behaviour

    10 weeks

  • Weight

    10 weeks

  • Blood pressure

    10 weeks

  • Blood cholesterol

    10 weeks

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Other: aktivplan

Control

OTHER
Other: Usual care

Interventions

aktivplanOTHER

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.

Intervention
Usual careOTHER

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

REHA Zentrum Salzburg

Salzburg, Salzburg, 5020, Austria

Location

Reha-Klinik Montafon

Schruns, Vorarlberg, 6780, Austria

Location

Related Publications (1)

  • Leysen D, Reich B, Carrozzo AE, Crutzen R, Grote V, Kumar D, Mayr B, Niebauer J, Pfannerstill F, Propst EM, Wurhofer D, Sareban M, Smeddinck JD, Treff G, Kulnik ST. Feasibility of the aktivplan Digital Health Intervention for Regular Physical Activity Following Phase II Rehabilitation: Protocol for a Mixed Method Randomized Controlled Pilot Study (ACTIVE-CaRe Pilot). JMIR Res Protoc. 2025 Sep 15;14:e73704. doi: 10.2196/73704.

    PMID: 40953438DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Stefan T Kulnik, PhD MRes

    Ludwig Boltzmann Institute for Digital Health and Prevention

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 6, 2023

Study Start

October 2, 2023

Primary Completion

July 29, 2024

Study Completion

August 31, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)