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Group-based Cardiac Telerehabilitation and Its Effectiveness

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group- based cardiac telerehabilitation
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Cardiac telerehabilitation, Quality of life, Adherence to treatment, Lifestyle change

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Goup-based cardiac telerehabilitation

    Usual care for cardiac patients

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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).
    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').
    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').
    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').

    Secondary Outcome Measures

    Full Information

    First Posted
    June 5, 2023
    Last Updated
    June 19, 2023
    Sponsor
    University of Eastern Finland
    Collaborators
    Oulu University Hospital, Kuopio University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05923580
    Brief Title
    Group-based Cardiac Telerehabilitation and Its Effectiveness
    Official Title
    Group-based Cardiac Telerehabilitation and Its Effectiveness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Eastern Finland
    Collaborators
    Oulu University Hospital, Kuopio University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    Coronary artery disease, Cardiac telerehabilitation, Quality of life, Adherence to treatment, Lifestyle change

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Masking Description
    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)
    Allocation
    Non-Randomized
    Enrollment
    198 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Goup-based cardiac telerehabilitation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual care for cardiac patients
    Arm Type
    No Intervention
    Arm Description
    The coronary patient is in primary care under the supervision of a nurse and a doctor.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group- based cardiac telerehabilitation
    Other Intervention Name(s)
    Tulppa- telerehabilitation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in The health-related quality of life at 12 Months
    Description
    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).
    Time Frame
    Baseline and 12 Months
    Title
    Change from Baseline in The Adherence to Treatment at 12 Months
    Description
    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').
    Time Frame
    Baseline and 12 Months
    Title
    Change from Baseline in The Adherence to Medication at 12 Months
    Description
    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').
    Time Frame
    Baseline and 12 Months
    Title
    Change from Baseline in Health and Well- being at 12 Months
    Description
    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').
    Time Frame
    Baseline and 12 Months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Men, women, other gender, do not want to tell
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Renuka J Jacobsson, MHSc
    Phone
    +358504111741
    Email
    renukaj@uef.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Päivi Kankkunen, docent
    Phone
    +358 29 4454435
    Email
    paivi.kankkunen@uef.fi

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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