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Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04493437
Enrollment
20
Registered
2020-07-30
Start date
2019-12-02
Completion date
2021-05-26
Last updated
2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

The idea behind this Future Patient pilot study is to explore and evaluate the feasibility of individualized telerehabilitation technologies and programs for patients with atrial fibrillation (AF).

Detailed description

Objective: To explore the feasibility of individualized telerehabilitation technologies and a program for patients with AF. Outcome measures: To evaluate two concepts for telerehabilitation programs and technologies for patients with AF in order to see how these concepts can increase self-management for patients in their rehabilitation process. The following outcome measures are in focus: Primary outcomes: * Usability of technologies seen from patients' and healthcare professionals' perspectives * Test and evaluation of the contents of telerehabilitation programs Secondary outcomes: * Measurements of clinical data * Patients' and relatives' expectations for and experience with participation in the telerehabilitation program * Healthcare professionals' experience with workflows and collaboration between each other in the telerehabilitation program

Interventions

DEVICETelerehabilitation

Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).

Sponsors

Aage and Johanne Louis-Hansens Foundation
CollaboratorUNKNOWN
Laboratory of Welfare Technology, Department of Health Science and Technology, AAU
CollaboratorUNKNOWN
Viborg Regional Hospital
CollaboratorOTHER
Skive Healthcare Center
CollaboratorUNKNOWN
Viborg Healthcare Center
CollaboratorUNKNOWN
University of Aarhus
CollaboratorOTHER
Department of Photonics Engineering, Technical University of Denmark
CollaboratorUNKNOWN
Aalborg University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with AF * Adults ≥ 18 years; no upper age limit * Patients living in Skive and Viborg Municipality * Living at home and capable of caring for him/herself * Basic computer skills or a relative with basic computer skills

Exclusion criteria

* Pregnancy * Lack of ability to cooperate * Patient does not speak, read and understand Danish

Design outcomes

Primary

MeasureTime frameDescription
Clinical test of the contents of telerehabilitation programs using interviewsAt day 30Interviews with patients regarding the use of technology, themes on rehabilitation for AF patients on web portal, and education at healthcare center
Usability test of technologies seen from patients' and healthcare professionals' perspectivesAt day 30Interviews with patients regarding the user-friendliness of technologies and layout on web portal

Secondary

MeasureTime frameDescription
Measurements of weightEvery Wednesday: week 1, 2, 3, 4, and 5.Evaluation of changes in weight in kg measured ones a week
Measurements of electrocardiography (ECG) ECG QT IntervalEvery Wednesday: week 1, 2, 3, 4, and 5.Evaluation of ECG QT Interval measured ones a week
Measurements of blood pressureEvery Wednesday: week 1, 2, 3, 4, and 5.Evaluation of changes in systolic and diastolic blood pressure measured ones a week
Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation programAt day 30Interviews with patients and relatives regarding their experiences with participation in the tele rehabilitation program
Measurements of number of steps and sleepEveryday: week 1, 2, 3, 4, and 5.Evaluation of changes in number of steps and sleep measured every day
Measurements of pulseEvery Wednesday: week 1, 2, 3, 4, and 5.Evaluation of changes in pulse in beats per minut measured ones a week

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026