Future Patient - Telerehabilitation of Atrial Fibrillation Patients

NCT ID: NCT04493437

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2021-05-26

Brief Summary

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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

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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

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type 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).

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.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aage and Johanne Louis-Hansens Foundation

UNKNOWN

Sponsor Role collaborator

Laboratory of Welfare Technology, Department of Health Science and Technology, AAU

UNKNOWN

Sponsor Role collaborator

Viborg Regional Hospital

OTHER

Sponsor Role collaborator

Skive Healthcare Center

UNKNOWN

Sponsor Role collaborator

Viborg Healthcare Center

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Department of Photonics Engineering, Technical University of Denmark

UNKNOWN

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Birthe Dinesen

Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology, Viborg Regional Hospital

Viborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 34279239 (View on PubMed)

Other Identifiers

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N-20190059

Identifier Type: -

Identifier Source: org_study_id

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