Future Patient - Telerehabilitation of Patients With Atrial Fibrillation

NCT ID: NCT06101485

Last Updated: 2023-10-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-06-30

Brief Summary

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This project has focus on patients with atrial fibrillation testing a telerehabilitation program for patients with atrial fibrillation.

Detailed Description

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The overall aim of the FP-AF program is to increase quality of life by giving the patients and relatives more knowledge about atrial fibrillation, its symptoms, and the issues of living with atrial fibrillation in everyday life. The specific aims are to individualize the rehabilitation process and help the patients and relatives develop their own self-management strategies using their own clinical data and their enhanced knowledge about AF.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telerehabilitation group

The telerehabilitation group (n=104) will participate in the FP-AF program for 16 weeks. The program is administered by the AF clinics and the healthcare centers (HC) in Viborg, Skive and Silkeborg Municipalities. After enrollment, the patients will have an individual meeting with the project nurse. Here the patient (and relatives, if necessary) will be instructed in the use of the technologies and an individual plan will be formulated for the AF patient's telerehabilitation. After participation in 16 weeks the patients start a 12 weeks follow-up period, where they will only measure steps and have access to the Heartportal on their own devices.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type DEVICE

Telerehabilitation platform: Hjerteportalen, blood pressure monitor (iHealth(neo/BP5s), weight scale (iHealth Lina), Activity tracker (FitBit inspire 3), ECG monitor (AliveCor KardiaMobile), sleep sensor (Emfit QS), video consultation (VDX by MedCom)

Conventional rehabilitation

The control group (n=104) will follow the conventional care regime in the AF clinic and will not have contact to the project nurse. When the AF patients are in a stable condition, they will be followed by their general practitioner (GP). The control group will be in the study for 28 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telerehabilitation

Telerehabilitation platform: Hjerteportalen, blood pressure monitor (iHealth(neo/BP5s), weight scale (iHealth Lina), Activity tracker (FitBit inspire 3), ECG monitor (AliveCor KardiaMobile), sleep sensor (Emfit QS), video consultation (VDX by MedCom)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with atrial fibrillation
* Adults over 18 years
* Living in Skive, Viborg or Silkeborg Municipalities
* Living at home and capable of caring for themselves
* Have basic computer skills or having a relative/friend with basic computer skills

Exclusion Criteria

* Pregnancy
* Refusal or inability to cooperate; or patient not does not speak, read or understand Danish
* Life expectancy less than a year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Cardiology, Viborg Regional Hospital

UNKNOWN

Sponsor Role collaborator

Department of Cardiology, Silkeborg Regional Hospital

UNKNOWN

Sponsor Role collaborator

Center for Innovative Medical Technologies (CIMT), Odense University Hospital

UNKNOWN

Sponsor Role collaborator

Laboratory for Welfare Technology, Department of Health Science and Technology, Aalborg University

UNKNOWN

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Birthe Dinesen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birthe Dinesen, MSc, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Dorthe Svenstrup, MD, Ph.D

Role: STUDY_DIRECTOR

Central Jutland Regional Hospital, Viborg

Lars Frost, MD, Ph.D, DMSc

Role: STUDY_DIRECTOR

Central Jutland Regional Hospital, Silkeborg

Locations

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Central Jutland Regional Hospital

Viborg and Silkeborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Birthe Dinesen, MSc, Ph.D

Role: CONTACT

004520515944

Dorthe Svenstrup, MD, Ph.D

Role: CONTACT

004578447051

Facility Contacts

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Dorthe Svenstrup, MD, Ph.D

Role: primary

004578447051

References

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Dinesen B, Albertsen AE, Joensen EDR, Spindler H, Jensen KM, Kidholm K, Frost L, Dittman L, Gunasegaram M, Johnsen SP, Jochumsen MR, Svenstrup D. Future Patient-Telerehabilitation of Patients With Atrial Fibrillation: Protocol for a Multicenter, Mixed Methods, Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 18;14:e64259. doi: 10.2196/64259.

Reference Type DERIVED
PMID: 39965197 (View on PubMed)

Related Links

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https://www.labwelfaretech.com/fp/af/

Read more about the trial at the homepage for the Laboratory for Welfare Technology - Digital health \& rehabilitation, Aalborg University

Other Identifiers

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N-20220056

Identifier Type: -

Identifier Source: org_study_id

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