Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Atrial Fibrillation Clinical Trial

Official title:

Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493437
• Other study ID #: N-20190059
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: May 26, 2021

Study information

• Verified date: May 2021
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 26, 2021
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Telerehabilitation
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).

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Viborg Regional Hospital	Viborg

Sponsors (9)

Lead Sponsor	Collaborator
Aalborg University	Aage and Johanne Louis-Hansens Foundation, Department of Architecture, Design and Media Technology, Aalborg University, Department of Photonics Engineering, Technical University of Denmark, Department of Psychology, Aarhus University, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Skive Healthcare Center, Viborg Healthcare Center, Viborg Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical test of the contents of telerehabilitation programs using interviews	Interviews with patients regarding the use of technology, themes on rehabilitation for AF patients on web portal, and education at healthcare center	At day 30
Primary	Usability test of technologies seen from patients' and healthcare professionals' perspectives	Interviews with patients regarding the user-friendliness of technologies and layout on web portal	At day 30
Secondary	Measurements of blood pressure	Evaluation of changes in systolic and diastolic blood pressure measured ones a week	Every Wednesday: week 1, 2, 3, 4, and 5.
Secondary	Measurements of pulse	Evaluation of changes in pulse in beats per minut measured ones a week	Every Wednesday: week 1, 2, 3, 4, and 5.
Secondary	Measurements of weight	Evaluation of changes in weight in kg measured ones a week	Every Wednesday: week 1, 2, 3, 4, and 5.
Secondary	Measurements of electrocardiography (ECG) ECG QT Interval	Evaluation of ECG QT Interval measured ones a week	Every Wednesday: week 1, 2, 3, 4, and 5.
Secondary	Measurements of number of steps and sleep	Evaluation of changes in number of steps and sleep measured every day	Everyday: week 1, 2, 3, 4, and 5.
Secondary	Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation program	Interviews with patients and relatives regarding their experiences with participation in the tele rehabilitation program	At day 30