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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Rehabilitation Secondary Prevention Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

aktivplan

Intervention Type 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.

Control

Group Type OTHER

Usual care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No