Future Patient - Telerehabilitation of Patients With Atrial Fibrillation

NCT06101485 | Unknown

• 1 other identifier: N-20220056
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Telerehabilitation; Quality of life; Cardiac patients; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Changes in AF specific health-related quality of life

  The Atrial Fibrillation Effect on quality of life questionnaire (AFEQT) is a 20-item self-administered questionnaire designed to assess the impact of AF on the patients' health-related quality of life (HRQoL) across symptoms, daily activities, treatment concerns, and treatment satisfaction. Scores range from 0-100, with higher scores indicating better HRQoL

  For both intervention and control group: QoL will be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks

Secondary Outcomes (25)

• Changes in AF knowledge

  For both intervention and control group: To be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks

• Measurement of weight

  Intervention group: Weight will be measured at baseline, twice a week, and as needed up to 16 weeks

• Measurement of bloodpressure

  Intervention group: Bloodpressure will be measured at baseline, twice a week, and as needed up to 16 weeks

• Measurement of pulse

  Intervention group: Pulse will be measured at baseline, everyday, and as needed up to 16 weeks

• Measurement of steps

  Intervention group: Steps will be measured from the date of randomization, everyday to end follow up (28 weeks)

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

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.

Device: Telerehabilitation

Conventional rehabilitation

NO INTERVENTION

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.

Interventions

Telerehabilitation 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)

Telerehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University: lead
• Department of Cardiology, Viborg Regional Hospital: collaborator
• Department of Cardiology, Silkeborg Regional Hospital: collaborator
• Center for Innovative Medical Technologies (CIMT), Odense University Hospital: collaborator
• Laboratory for Welfare Technology, Department of Health Science and Technology, Aalborg University: collaborator

Study Sites (1)

Central Jutland Regional Hospital

Viborg and Silkeborg, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 39965197 DERIVED

Related Links

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

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Birthe Dinesen, MSc, Ph.D

  Aalborg University

  PRINCIPAL INVESTIGATOR

• Dorthe Svenstrup, MD, Ph.D

  Central Jutland Regional Hospital, Viborg

  STUDY DIRECTOR

• Lars Frost, MD, Ph.D, DMSc

  Central Jutland Regional Hospital, Silkeborg

  STUDY DIRECTOR

Central Study Contacts

Birthe Dinesen, MSc, Ph.D

CONTACT

004520515944; bid@hst.aau.dk

Dorthe Svenstrup, MD, Ph.D

CONTACT

004578447051; dorthmoe@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 30, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)