Atrial FibrillationNCT04493437
Future Patient - Telerehabilitation of Atrial Fibrillation Patients
A study testing Telerehabilitation in people with Atrial Fibrillation, run by Aalborg University at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Telerehabilitation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Dec 2019to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Lack of ability to cooperate
- Patient does not speak, read and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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
- Atrial Fibrillation
- Being tested
- Telerehabilitation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At day 30
Secondary outcomes (6)
Measurements of blood pressure
Evaluation of changes in systolic and diastolic blood pressure measured ones a week
Measured: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of pulse
Evaluation of changes in pulse in beats per minut measured ones a week
Measured: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of weight
Evaluation of changes in weight in kg measured ones a week
Measured: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of electrocardiography (ECG) ECG QT Interval
Evaluation of ECG QT Interval measured ones a week
Measured: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of number of steps and sleep
Evaluation of changes in number of steps and sleep measured every day
Measured: Everyday: week 1, 2, 3, 4, and 5.
Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation program
Interviews with patients and relatives regarding their experiences with participation in the tele rehabilitation program
Measured: At day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start2 Dec 2019
- Primary completion28 Feb 2020
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aage and Johanne Louis-Hansens Foundation, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Viborg Regional Hospital, Skive Healthcare Center, Viborg Healthcare Center, University of Aarhus, Technical University of Denmark
- Responsible party
- Principal investigator, Birthe Dinesen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493437
- Sponsor's protocol ID
- N-20190059
- Status last verified
- May 2021
- First submitted
- 28 May 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34279239
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Patient - Telerehabilitation of Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT04493437
- Acronym / sponsor ID
- N-20190059
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aage and Johanne Louis-Hansens Foundation, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Viborg Regional Hospital, Skive Healthcare Center, Viborg Healthcare Center, University of Aarhus, Technical University of Denmark
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group A | Experimental | Device: TelerehabilitationDevice: 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). |
| Telerehabilitation group B | Experimental | Device: TelerehabilitationDevice: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Lack of ability to cooperate
- Patient does not speak, read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationBlood 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 group A, Telerehabilitation group B |
Primary outcome
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
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
6 secondary outcomes
Measurements of blood pressure
Time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of pulse
Time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of weight
Time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of electrocardiography (ECG) ECG QT Interval
Time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
Measurements of number of steps and sleep
Time frame: Everyday: week 1, 2, 3, 4, and 5.
Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation program
Time frame: At day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 34279239Dinesen 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Atrial Fibrillation, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical test of the contents of telerehabilitation programs using interviews (time frame: At day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.