NCT04493437

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 28, 2020

Last Update Submit

May 26, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Clinical test of the contents of telerehabilitation programs using interviews

    Interviews with patients regarding the use of technology, themes on rehabilitation for AF patients on web portal, and education at healthcare center

    At day 30

  • Usability test of technologies seen from patients' and healthcare professionals' perspectives

    Interviews with patients regarding the user-friendliness of technologies and layout on web portal

    At day 30

Secondary Outcomes (6)

  • Measurements of blood pressure

    Every Wednesday: week 1, 2, 3, 4, and 5.

  • Measurements of pulse

    Every Wednesday: week 1, 2, 3, 4, and 5.

  • Measurements of weight

    Every Wednesday: week 1, 2, 3, 4, and 5.

  • Measurements of electrocardiography (ECG) ECG QT Interval

    Every Wednesday: week 1, 2, 3, 4, and 5.

  • Measurements of number of steps and sleep

    Everyday: week 1, 2, 3, 4, and 5.

  • +1 more secondary outcomes

Study Arms (2)

Telerehabilitation group A

EXPERIMENTAL

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

Telerehabilitation group B

EXPERIMENTAL

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

Interventions

TelerehabilitationDEVICE

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 ATelerehabilitation group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Lack of ability to cooperate
  • Patient does not speak, read and understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Viborg Regional Hospital

Viborg, 8800, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34279239DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation

Study Record Dates

First Submitted

May 28, 2020

First Posted

July 30, 2020

Study Start

December 2, 2019

Primary Completion

February 28, 2020

Study Completion

May 26, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)