Clinical trial NCT06101485: Future Patient - Telerehabilitation of Patients With Atrial Fibrillation
Official title: Future Patient - Telerehabilitering af Patienter Med Atrieflimren (FP-AF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Telerehabilitation
Quality of life
Cardiac patients
Atrial fibrillation
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Department of Cardiology, Viborg Regional Hospital
name: Department of Cardiology, Silkeborg Regional Hospital
name: Center for Innovative Medical Technologies (CIMT), Odense University Hospital
name: Laboratory for Welfare Technology, Department of Health Science and Technology, Aalborg University
First posted: 2023-10-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in AF specific health-related quality of life
timeFrame: For both intervention and control group: QoL will be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks
Secondary outcomes:
measure: Changes in AF knowledge
timeFrame: For both intervention and control group: To be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks
measure: Measurement of weight
timeFrame: Intervention group: Weight will be measured at baseline, twice a week, and as needed up to 16 weeks
measure: Measurement of bloodpressure
timeFrame: Intervention group: Bloodpressure will be measured at baseline, twice a week, and as needed up to 16 weeks
measure: Measurement of pulse
timeFrame: Intervention group: Pulse will be measured at baseline, everyday, and as needed up to 16 weeks
measure: Measurement of steps
timeFrame: Intervention group: Steps will be measured from the date of randomization, everyday to end follow up (28 weeks)
measure: Measurement of sleep
timeFrame: Intervention group: Sleep will be measured every day up to 16 weeks
measure: Measurement of heart rhythm
timeFrame: Intervention group: ECG wil be measured at baseline, twice a week, and as needed up to 16 weeks
measure: Changes in anxiety and depression
timeFrame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
measure: Changes in motivation
timeFrame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
measure: Changes in motivation
timeFrame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
measure: Changes in motivation
timeFrame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
measure: Burden of AF
timeFrame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
measure: Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)
timeFrame: Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks)
measure: Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)
timeFrame: Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks)
measure: Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.
timeFrame: Intervention group: End of telerehabilitation (16 weeks)
measure: Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.
timeFrame: Intervention group: End of telerehabilitation (16 weeks)
measure: Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care
timeFrame: Both intervention and control group: at the end of telerehabilitation (16 weeks)
measure: Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care
timeFrame: Both intervention and control group: At the end of telerehabilitation (16 weeks) and at end follow up (28 weeks)
measure: Patterns in multiparametric clinical monitoring
timeFrame: Intervention group: At the end of telerehabilitation (16 weeks).
measure: Patterns in multiparametric clinical monitoring
timeFrame: Intervention group: At the end of telerehabilitation (16 weeks).
measure: Patterns in multiparametric clinical monitoring
timeFrame: Intervention group: At the end of telerehabilitation (16 weeks).
measure: Patterns in multiparametric clinical monitoring
timeFrame: Intervention group: At the end of telerehabilitation (16 weeks).
measure: Patterns in multiparametric clinical monitoring
timeFrame: Intervention group: At the end of telerehabilitation (16 weeks).
measure: Patterns in multiparametric clinical monitoring
timeFrame: Intervention group: At the end of telerehabilitation (16 weeks).
measure: Future governance and infrastructure for telerehabilitation of AF patients
timeFrame: Intervention group: At the end of telerehabilitation (16 weeks)
Other outcomes:
Locations:
city: Viborg And Silkeborg
country: Denmark
facility: Central Jutland Regional Hospital
Study officials:
affiliation: Aalborg University
name: Birthe Dinesen, MSc, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Jutland Regional Hospital, Viborg
name: Dorthe Svenstrup, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Central Jutland Regional Hospital, Silkeborg
name: Lars Frost, MD, Ph.D, DMSc
role: STUDY_DIRECTOR
References: