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Clinical Trials/NCT06320652
NCT06320652
Recruiting
N/A

Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation - a Study on Health Literacy, Health Related Quality of Life, and Family Support

Copenhagen University Hospital, Hvidovre1 site in 1 country140 target enrollmentMay 2, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Rehabilitation
Sponsor
Copenhagen University Hospital, Hvidovre
Enrollment
140
Locations
1
Primary Endpoint
Health Literacy Questonnaire
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses.

Detailed Description

The project is designed inspired by The Complex Intervention Framework (MRC-Guidelines) combined with a patient and family participatory design. The project will consist of three sub-studies. The first study is a co-creation development of a model for the cardiac telerehabilitation intervention. The second study is a quasi-experimental study with a quantitative comparison of the group receiving the cardiac telerehabilitation intervention and control group. The third study will be a descriptive qualitative study which aim to investigate patient's experience with CTR using participant observation and individual interview or dyadic interview.

Registry
clinicaltrials.gov
Start Date
May 2, 2024
End Date
August 31, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copenhagen University Hospital, Hvidovre
Responsible Party
Principal Investigator
Principal Investigator

Nina Cecilie Tjustrup

PhD student, MSc, RN

Copenhagen University Hospital, Hvidovre

Eligibility Criteria

Inclusion Criteria

  • Patients and their family members affiliated with the Department of Cardiology at Amager and Hvidovre Hospital and attending cardiac rehabilitation.
  • Patients diagnosed with ischemic heart disease, heart failure, persistent atrial fibrillation, and cardiac valve surgery.

Exclusion Criteria

  • Patients with substantial language barriers and limited cognitive function.
  • Patients who can't use a smart phone, tablet, or computer.

Outcomes

Primary Outcomes

Health Literacy Questonnaire

Time Frame: 3 months

Health literacy is investigated through instruments such as the Health Literacy Questionnaire (HQL). The HLQ contains 44 qustions that cover nine conceptually distinct areas of Health Literacy. Response options for each scale are determined by the content and nature of the items. For scale 1-5 four point ordinal response options are used (strongly disagree, disagree, agree and strongly agree), while for scales 6-9 five-point ordinal response options are used (cannot do, very difficult, quite difficult, quite easy and very easy). HLQ scale scores are calculated as unit-weighted sums of the constituents items averaged by the number of items in the scale such that the nominal range of the scale scores are 1-4 for scale 1-5 and 1-5 for scale 6-9. A low score means worse outcome and a high score means better outcome.

Secondary Outcomes

  • The European Quality of life five dimensions questionnaire(3 months)
  • The eHealth Literacy Questionnaire(3 months)
  • The Iceland-Family Perceived Support Questionnaire(3 months)

Study Sites (1)

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