Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Study Overview
=================
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

Official Title
-----------------
Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Telerehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation group A<br>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<br>* 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).<br>|
| Experimental: Telerehabilitation group B<br>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<br>* 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).<br>|

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 |