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Completed

NCT Number: NCT04493437

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Viborg Regional Hospital

Viborg, 8800, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telerehabilitation

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Aage and Johanne Louis-Hansens Foundation
  • Laboratory of Welfare Technology, Department of Health Science and Technology, AAU
  • Skive Healthcare Center
  • Technical University of Denmark
  • University of Aarhus
  • Viborg Healthcare Center
  • Viborg Regional Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 30, 2020
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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