Future Patient - Telerehabilitation of Atrial Fibrillation Patients

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Telerehabilitation

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Department of Cardiology, Viborg Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Telerehabilitation group A; 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).	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).
EXPERIMENTAL: Telerehabilitation group B; Device: Telerehabilitation + rehabilitation at health care center 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). Rehabilitation at health care center: The rehabilitation will consist of four closed group sessions focusing on patient education. The groups will consist of both patients and relatives. The program at the health care center will not include any psychological tests or data control. Duration is 4 x 2 hours sessions over a period of 1 month.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Measurements of weight	Evaluation of changes in weight in kg measured ones a week	Every Wednesday: week 1, 2, 3, 4, and 5.
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.
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.
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2019
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): May 26, 2021

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: N-20190059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No