Future Patient - Telerehabilitation of Atrial Fibrillation Patients

Sponsor
Aalborg University (Other)
Overall Status
Completed
CT.gov ID
NCT04493437
Collaborator
Aage and Johanne Louis-Hansens Foundation (Other), Laboratory of Welfare Technology, Department of Health Science and Technology, AAU (Other), Viborg Regional Hospital (Other), Skive Healthcare Center (Other), Viborg Healthcare Center (Other), Department of Psychology, Aarhus University (Other), Department of Architecture, Design and Media Technology, Aalborg University (Other), Department of Photonics Engineering, Technical University of Denmark (Other)
20
1
2
17.8
1.1

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Telerehabilitation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Future Patient - Telerehabilitation of Atrial Fibrillation Patients
Actual Study Start Date :
Dec 2, 2019
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Clinical test of the contents of telerehabilitation programs using interviews [At day 30]

    Interviews with patients regarding the use of technology, themes on rehabilitation for AF patients on web portal, and education at healthcare center

  2. Usability test of technologies seen from patients' and healthcare professionals' perspectives [At day 30]

    Interviews with patients regarding the user-friendliness of technologies and layout on web portal

Secondary Outcome Measures

  1. Measurements of blood pressure [Every Wednesday: week 1, 2, 3, 4, and 5.]

    Evaluation of changes in systolic and diastolic blood pressure measured ones a week

  2. Measurements of pulse [Every Wednesday: week 1, 2, 3, 4, and 5.]

    Evaluation of changes in pulse in beats per minut measured ones a week

  3. Measurements of weight [Every Wednesday: week 1, 2, 3, 4, and 5.]

    Evaluation of changes in weight in kg measured ones a week

  4. Measurements of electrocardiography (ECG) ECG QT Interval [Every Wednesday: week 1, 2, 3, 4, and 5.]

    Evaluation of ECG QT Interval measured ones a week

  5. Measurements of number of steps and sleep [Everyday: week 1, 2, 3, 4, and 5.]

    Evaluation of changes in number of steps and sleep measured every day

  6. Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation program [At day 30]

    Interviews with patients and relatives regarding their experiences with participation in the tele rehabilitation program

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiology, Viborg Regional Hospital Viborg Denmark 8800

Sponsors and Collaborators

  • Aalborg University
  • 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Birthe Dinesen, Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation, Aalborg University
ClinicalTrials.gov Identifier:
NCT04493437
Other Study ID Numbers:
  • N-20190059
First Posted:
Jul 30, 2020
Last Update Posted:
May 27, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2021