NCT06025526

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

Completed NA Last updated 9 October 2024

What this trial tests

NA trial testing aktivplan in Cardiac Rehabilitation in 34 participants. Completed in 31 August 2024.

Timeline

2 October 2023

Primary endpoint
29 July 2024

31 August 2024

Quick facts

Lead sponsor	Ludwig Boltzmann Institute for Digital Health and Prevention
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	2 October 2023
Primary completion	29 July 2024
Estimated completion	31 August 2024
Sites	2 locations across Austria

Drugs / interventions tested

• aktivplan
• Usual care

Conditions studied

• Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →
• Secondary Prevention — all drugs for Secondary Prevention →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention

Who can join

18 and older, any sex, with Cardiac Rehabilitation or Secondary Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Making it transparent: A worked example of articulating programme theory for a digital health application using Intervention Mapping.
   Marcos TA, Crutzen R, Leitner V, Smeddinck JD, et al · · 2024 · cited 5× · PMID 38894945 · DOI 10.1177/20552076241260974
2. 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).
   Leysen D, Reich B, Carrozzo AE, Crutzen R, et al · · 2025 · cited 1× · PMID 40953438 · DOI 10.2196/73704