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Future Patient - Telerehabilitation of Atrial Fibrillation Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493437
Recruitment Status : Active, not recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
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
Information provided by (Responsible Party):
Birthe Dinesen, Aalborg University

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
Atrial Fibrillation Device: Telerehabilitation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : December 2, 2019
Actual Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Clinical test of the contents of telerehabilitation programs using interviews [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At day 30 ]
    Interviews with patients and relatives regarding their experiences with participation in the tele rehabilitation program



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493437


Locations
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Denmark
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
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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: July 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes