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RecruitingNCT05923580Updated May 8, 2024

Group-based Cardiac Telerehabilitation and Its Effectiveness

An interventional study of Group- based cardiac telerehabilitation in Coronary Artery Disease, sponsored by University of Eastern Finland. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Eastern Finland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease
  • Cardiac telerehabilitation
  • Quality of life
  • Adherence to treatment
  • Lifestyle change
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Participants must not have coronary artery disease diagnosed.
  • Participants have been in other operations than percutaneous coronary intervention.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Group- based cardiac telerehabilitation

  • No intervention
    Usual care for cardiac patients

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

Interventions

  • BehavioralGroup- 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.

    Also known as: Tulppa- telerehabilitation

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and 12 Months

  2. 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').

    Time frame: Baseline and 12 Months

  3. 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').

    Time frame: Baseline and 12 Months

  4. 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').

    Time frame: Baseline and 12 Months

06

Study locations

1 of 1 sites recruiting
  • Renuka Julia Jacobsson
    Tuusula, Uusimaa 04300, Finland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05923580
Lead sponsor
University of Eastern Finland
Collaborators
Oulu University Hospital, Kuopio University Hospital
Responsible party
Sponsor
First posted
Jun 28, 2023
Start date
Aug 1, 2023
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
May 8, 2024

Study contacts

Renuka J Jacobsson, MHSc
Contact
renukaj@uef.fi
+358504111741
Päivi Kankkunen, docent
Contact
paivi.kankkunen@uef.fi
+358 29 4454435

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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