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Clinical Trials/NCT06101485
NCT06101485
Recruiting
Not Applicable

Future Patient - Telerehabilitering af Patienter Med Atrieflimren (FP-AF)

Aalborg University1 site in 1 country208 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Aalborg University
Enrollment
208
Locations
1
Primary Endpoint
Changes in AF specific health-related quality of life
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This project has focus on patients with atrial fibrillation testing a telerehabilitation program for patients with atrial fibrillation.

Detailed Description

The overall aim of the FP-AF program is to increase quality of life by giving the patients and relatives more knowledge about atrial fibrillation, its symptoms, and the issues of living with atrial fibrillation in everyday life. The specific aims are to individualize the rehabilitation process and help the patients and relatives develop their own self-management strategies using their own clinical data and their enhanced knowledge about AF.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
June 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Birthe Dinesen

Professor

Aalborg University

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with atrial fibrillation
  • Adults over 18 years
  • Living in Skive, Viborg or Silkeborg Municipalities
  • Living at home and capable of caring for themselves
  • Have basic computer skills or having a relative/friend with basic computer skills

Exclusion Criteria

  • Pregnancy
  • Refusal or inability to cooperate; or patient not does not speak, read or understand Danish
  • Life expectancy less than a year

Outcomes

Primary Outcomes

Changes in AF specific health-related quality of life

Time Frame: For both intervention and control group: QoL will be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks

The Atrial Fibrillation Effect on quality of life questionnaire (AFEQT) is a 20-item self-administered questionnaire designed to assess the impact of AF on the patients' health-related quality of life (HRQoL) across symptoms, daily activities, treatment concerns, and treatment satisfaction. Scores range from 0-100, with higher scores indicating better HRQoL

Secondary Outcomes

  • Measurement of bloodpressure(Intervention group: Bloodpressure will be measured at baseline, twice a week, and as needed up to 16 weeks)
  • Measurement of heart rhythm(Intervention group: ECG wil be measured at baseline, twice a week, and as needed up to 16 weeks)
  • Changes in motivation(Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.)
  • Patterns in multiparametric clinical monitoring(Intervention group: At the end of telerehabilitation (16 weeks).)
  • Measurement of sleep(Intervention group: Sleep will be measured every day up to 16 weeks)
  • Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.(Intervention group: End of telerehabilitation (16 weeks))
  • Changes in AF knowledge(For both intervention and control group: To be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks)
  • Changes in anxiety and depression(Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.)
  • Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)(Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks))
  • Measurement of steps(Intervention group: Steps will be measured from the date of randomization, everyday to end follow up (28 weeks))
  • Burden of AF(Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.)
  • Measurement of weight(Intervention group: Weight will be measured at baseline, twice a week, and as needed up to 16 weeks)
  • Measurement of pulse(Intervention group: Pulse will be measured at baseline, everyday, and as needed up to 16 weeks)
  • Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care(Both intervention and control group: At the end of telerehabilitation (16 weeks) and at end follow up (28 weeks))
  • Future governance and infrastructure for telerehabilitation of AF patients(Intervention group: At the end of telerehabilitation (16 weeks))

Study Sites (1)

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