Group-based Cardiac Telerehabilitation and Its Effectiveness

NCT ID: NCT05923580

Last Updated: 2024-05-08

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

RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-01

Brief Summary

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Cardiovascular diseases (CVD) and coronary artery diseases (CAD) are the most common cause of death worldwide. After an acute cardiac event, prevention of new cardiac events is essential and reduces suffering. Group-based cardiac telerehabilitation (CTR) refers to the use of information and communication technologies for rehabilitation purposes in promoting CAD patients´ health.

Detailed Description

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This study aims to assess the group-based cardiac telerehabilitation model and its effectiveness. The data is collected from two University hospitals in Finland. Patients with coronary heart disease two months after percutaneous coronary intervention (N=198) are invited to the study. All the participants are being treated in a healthcare unit that uses digital care pathways for coronary patients. Patients can choose the usual care or group-based cardiac telerehabilitation as follow-up care. All the patients are invited to the study after the chosen follow-up care (telerehabilitation or usual care). Patients will be allocated into two groups: The telerehabilitation group is the intervention group and the usual care group is the control group. Quality of life, adherence to treatment, and lifestyle changes are measured at the baseline and 3, 6, and 12 after the intervention baseline.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants' quality of life (measured with the 15D quality of life instrument), lifestyle changes, and adherence to treatment will be measured using quantitative methods with a quasi-experimental research design and interrupted time- series design. The power analysis for the study will be conducted using Finnish population norms for the 15D instrument. The sample size will be 198 cardiac rehabilitation participants (N=198), with 99 participants in the intervention group (N=99) and 99 participants in the control group (N=99). With this sample size, a power of over 80% (p=0.05) will be achieved to detect a difference of 0.12 (0.95 vs. 0.83, SD=0.3) in quality of life between the groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

All the participants are being treated in a healthcare unit that uses digital care pathways for coronary patients. Patients can choose the usual care or group-based cardiac telerehabilitation as follow-up care. All the patients are invited to the study after the chosen follow-up care (telerehabilitation or usual care)

Study Groups

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Goup-based cardiac telerehabilitation

Group-based cardiac telerehabilitation promotes information, skills, and support for the management of coronary artery disease in coronary patients. The rehabilitation model includes independent familiarization with information content, assignments, and group meetings, as well as the opportunity for a chat and peer support. The intervention is a health professional- lead, and registered rehabilitation model with a start and end.

Group Type EXPERIMENTAL

Group- based cardiac telerehabilitation

Intervention Type BEHAVIORAL

Group-based cardiac telerehabilitation promotes information, skills, and support for the management of coronary artery disease in coronary patients. The rehabilitation model includes independent familiarization with information content, assignments, and group meetings, as well as the opportunity for a chat and peer support. The intervention is a health professional- lead, and registered rehabilitation model with a start and end.

Usual care for cardiac patients

The coronary patient is in primary care under the supervision of a nurse and a doctor.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Group- based cardiac telerehabilitation

Group-based cardiac telerehabilitation promotes information, skills, and support for the management of coronary artery disease in coronary patients. The rehabilitation model includes independent familiarization with information content, assignments, and group meetings, as well as the opportunity for a chat and peer support. The intervention is a health professional- lead, and registered rehabilitation model with a start and end.

Intervention Type BEHAVIORAL

Other Intervention Names

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Tulppa- telerehabilitation

Eligibility Criteria

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Inclusion Criteria

* Participants must have patients with coronary heart disease two months after percutaneous coronary intervention.
* Participants must have ≥18 years of age, and ≤100 years of age
* Participants are being treated in a healthcare unit that uses digital care pathways for coronary patients.

Exclusion Criteria

* Participants must not have coronary artery disease diagnosed.
* Participants have been in other operations than percutaneous coronary intervention.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renuka Julia Jacobsson

Tuusula, Uusimaa, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Renuka J Jacobsson, MHSc

Role: CONTACT

+358504111741

Päivi Kankkunen, docent

Role: CONTACT

+358 29 4454435

Facility Contacts

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Renuka Julia Jacobsson

Role: primary

0504111741

Other Identifiers

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University of Eastern Finland

Identifier Type: -

Identifier Source: org_study_id

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