Clinical trial NCT04493437: Future Patient - Telerehabilitation of Atrial Fibrillation Patients
Official title: Future Patient - Telerehabilitation of Atrial Fibrillation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aage and Johanne Louis-Hansens Foundation
name: Laboratory of Welfare Technology, Department of Health Science and Technology, AAU
name: Viborg Regional Hospital
name: Skive Healthcare Center
name: Viborg Healthcare Center
name: University of Aarhus
name: Department of Photonics Engineering, Technical University of Denmark
First posted: 2020-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical test of the contents of telerehabilitation programs using interviews
timeFrame: At day 30
measure: Usability test of technologies seen from patients' and healthcare professionals' perspectives
timeFrame: At day 30
Secondary outcomes:
measure: Measurements of blood pressure
timeFrame: Every Wednesday: week 1, 2, 3, 4, and 5.
measure: Measurements of pulse
timeFrame: Every Wednesday: week 1, 2, 3, 4, and 5.
measure: Measurements of weight
timeFrame: Every Wednesday: week 1, 2, 3, 4, and 5.
measure: Measurements of electrocardiography (ECG) ECG QT Interval
timeFrame: Every Wednesday: week 1, 2, 3, 4, and 5.
measure: Measurements of number of steps and sleep
timeFrame: Everyday: week 1, 2, 3, 4, and 5.
measure: Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation program
timeFrame: At day 30
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Department of Cardiology, Viborg Regional Hospital
Study officials:
References:
citation: Dinesen B, Dam Gade J, Skov Schacksen C, Spindler H, Eie Albertsen A, Dittmann L, Jochumsen M, Svenstrup Moller D. The Danish Future Patient Telerehabilitation Program for Patients With Atrial Fibrillation: Design and Pilot Study in Collaboration With Patients and Their Spouses. JMIR Cardio. 2021 Jul 19;5(2):e27321. doi: 10.2196/27321.