Group-based Cardiac Telerehabilitation and Its Effectiveness

NCT05923580 | Recruiting

• 1 other identifier: University of Eastern Finland
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Cardiac telerehabilitation; Quality of life; Adherence to treatment; Lifestyle change

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in The health-related quality of life at 12 Months

  15D The health-related quality of life (HRQoL) instrument is a generic, comprehensive (15-dimensional), self-administered instrument for adults (age 16+ years). It combines the advantages of a profile and a preference-based, single index measure. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale, representing the overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL). Change = (Month 12 score- Baseline score).

  Baseline and 12 Months

• Change from Baseline in The Adherence to Treatment at 12 Months

  Adherence to Treatment is a self-assessment instrument designed to describe adherence to treatment of long-term conditions. The questionnaire contains 38 items of adherence to treatment, which are rated on a 5-point Likert scale ('definitely disagree' to 'definitely agree').

  Baseline and 12 Months

• Change from Baseline in The Adherence to Medication at 12 Months

  Adherence to Medication- instrument is a generic, self-administered instrument. The questionnaire contains items of adherence to medication, which are rated on a 5-point Likert scale ('definitely disagree' to 'definitely agree').

  Baseline and 12 Months

• Change from Baseline in Health and Well- being at 12 Months

  Health and well-being - the instrument is a generic, self-administered instrument. The questionnaire contains items on the factors influencing health and well-being (smoking, use of alcohol, eating habits, physical activity, sleep), which are rated on a 5-point Likert scale ('definitely disagree' to 'definitely agree').

  Baseline and 12 Months

Study Arms (2)

Goup-based cardiac telerehabilitation

EXPERIMENTAL

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.

Behavioral: Group- based cardiac telerehabilitation

Usual care for cardiac patients

NO INTERVENTION

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

Interventions

Group- based cardiac telerehabilitation 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.

Also known as: Tulppa- telerehabilitation

Goup-based cardiac telerehabilitation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Men, women, other gender, do not want to tell
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants must not have coronary artery disease diagnosed.
• Participants have been in other operations than percutaneous coronary intervention.

Sponsors & Collaborators

• University of Eastern Finland: lead
• Oulu University Hospital: collaborator
• Kuopio University Hospital: collaborator

Study Sites (1)

Renuka Julia Jacobsson

Tuusula, Uusimaa, 04300, Finland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Health Behavior; Behavior

Central Study Contacts

Renuka J Jacobsson, MHSc

CONTACT

+358504111741; renukaj@uef.fi

Päivi Kankkunen, docent

CONTACT

+358 29 4454435; paivi.kankkunen@uef.fi

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 28, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)