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Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Viborg Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Telerehabilitation group A

Telerehabilitation group B

Arm Description

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 + 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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Measurements of blood pressure
Evaluation of changes in systolic and diastolic blood pressure measured ones a week
Measurements of pulse
Evaluation of changes in pulse in beats per minut measured ones a week
Measurements of weight
Evaluation of changes in weight in kg measured ones a week
Measurements of electrocardiography (ECG) ECG QT Interval
Evaluation of ECG QT Interval measured ones a week
Measurements of number of steps and sleep
Evaluation of changes in number of steps and sleep measured every day
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

Full Information

First Posted
May 28, 2020
Last Updated
May 26, 2021
Sponsor
Aalborg University
Collaborators
Aage and Johanne Louis-Hansens Foundation, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Viborg Regional Hospital, 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
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1. Study Identification

Unique Protocol Identification Number
NCT04493437
Brief Title
Future Patient - Telerehabilitation of Atrial Fibrillation Patients
Official Title
Future Patient - Telerehabilitation of Atrial Fibrillation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Aage and Johanne Louis-Hansens Foundation, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Viborg Regional Hospital, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Cardiology, Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34279239
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.
Results Reference
derived

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Future Patient - Telerehabilitation of Atrial Fibrillation Patients

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