Atrial Fibrillation(FP-AF)NCT06101485
Future Patient - Telerehabilitation of Patients With Atrial Fibrillation
A study testing Telerehabilitation in people with Atrial Fibrillation, run by Aalborg University at 1 site in Denmark.
Trial summary
This project has focus on patients with atrial fibrillation testing a telerehabilitation program for patients with atrial fibrillation. 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
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 30 Jun 2025
- 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 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
Who cannot join
- Pregnancy
- Refusal or inability to cooperate; or patient not does not speak, read or understand Danish
- Life expectancy less than a year
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Central Jutland Regional Hospital
Viborg and Silkeborg
Dorthe Svenstrup, MD, Ph.D, 004578447051, dorthmoe@rm.dk
Lars Frost, MD, Ph.D
About this study
Official title: Future Patient - Telerehabilitering af Patienter Med Atrieflimren (FP-AF)
This project has focus on patients with atrial fibrillation testing a telerehabilitation program for patients with atrial fibrillation.
Read the detailed description
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
- Atrial Fibrillation
- Being tested
- Telerehabilitation
- Keywords
- Telerehabilitation, Quality of life, Cardiac patients, Atrial fibrillation
- 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
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Changes in AF knowledge assessed by the Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ). JAKQ is a 16-item scale used to assess the knowledge the patients have about their illness. For every item, false responses or "I do not know" responses is scored as 0 and the correct responses are scored as 1. The total score of the scale is calculated by adding up the scores from each item. A score between 0% and 100% will be generated. 100% is the best possible score, meaning all questions was answered correctly.
Measured: 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 (Kilograms)
Measured: Intervention group: Weight will be measured at baseline, twice a week, and as needed up to 16 weeks
Measurement of bloodpressure
Intervention group: Bloodpressure (mmHG) (systolic and diastolic)
Measured: Intervention group: Bloodpressure will be measured at baseline, twice a week, and as needed up to 16 weeks
Measurement of pulse
Intervention group: Pulse (numbers per minute)
Measured: Intervention group: Pulse will be measured at baseline, everyday, and as needed up to 16 weeks
Measurement of steps
Intervention group: numbers of steps taken
Measured: Intervention group: Steps will be measured from the date of randomization, everyday to end follow up (28 weeks)
Measurement of sleep
Intervention group: Sleep (numbers of hours per night)
Measured: Intervention group: Sleep will be measured every day up to 16 weeks
Measurement of heart rhythm
Intervention group: Electrocardiogram (ECG)
Measured: Intervention group: ECG wil be measured at baseline, twice a week, and as needed up to 16 weeks
Changes in anxiety and depression
The patients degree of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS). The patient will get a score between 0 and 21 for both depression and anxiety ( 0-7 points: low level of symptoms for depression or anxiety, 8-10 points: moderate level of symptoms for depression or anxiety, 11-21 points: high level of symptoms for depression or anxiety)
Measured: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Changes in motivation
Changes in motivation measured by Healthcare, Self-Determination Theory Questionnaire Packet (HC-SDTQ) comprised of Treatment Self-Regulation Questionnaire (TSRQ); Perceived Competence Scale (PCS); and Health Care Climate Questionnaire (HCCQ). TSRQ is used to assess different forms of motivation within the self determination theory (STD). The patients are asked to answer 15 questions regarding why they either follow or do not follow their treatment by marking to which degree each reason is true on a scale form 1 to 7, with 7 being very true.
Measured: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Changes in motivation
Changes in motivation measured by Healthcare, Self-Determination Theory Questionnaire Packet (HC-SDTQ) comprised of Treatment Self-Regulation Questionnaire (TSRQ); Perceived Competence Scale (PCS); and Health Care Climate Questionnaire (HCCQ). The PCS is used to assess the patients feeling of competence about engaging in, or maintaining, a healthier behavior. It is a short 4-item questionnaire where the patients have to indicate the extent to which each reason is true on a scale from 1 to 7, with 7 indicating 'very true'.
Measured: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Changes in motivation
Changes in motivation measured by Healthcare, Self-Determination Theory Questionnaire Packet (HC-SDTQ) comprised of Treatment Self-Regulation Questionnaire (TSRQ); Perceived Competence Scale (PCS); and Health Care Climate Questionnaire (HCCQ). The HCCQC is used to assess the degree to which a patient perceives their health care providers are supportive of their autonomy. It is a 6-item questionnaire where the patients have to indicate the extent to which each reason is true on a scale from 1 to 7, with 7 indicating 'very true'.
Measured: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Burden of AF
AF burden measured by the arrhythmia-specific questionnaire in Tachycardia and Arrhythmia (ASTA questionnaire). ASTA is used to assess symptoms and health-related quality of life(HRQoL) in patients with different forms of arrythmias, including AF. It is structured into three sections:Part I assesses demographic data such as the last episode of arrhythmia, current medication, and the presence of arrhythmia at the time of follow-up; Part II measures the arrhythmia-specific symptom burden; and part III assesses HRQoL. The ASTA 9-item symptom scale and the 13-item HRQoL scale utilize a four-point Likert-type scale, ranging from 'No' to 'Yes, a lot.' The total score ranges from 0 to 100, with a higher score indicating a greater symptom burden or a more negative impact on HRQoL.
Measured: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)
Perspectives and experiences of patients and relatives participating in the FP-AF program (including the Heartportal) measured by interviews with patients and relatives.
Measured: Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks)
Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)
Patients and relatives use of HeartPortal measured in logfiles on use \& via observation in everyday life
Measured: Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks)
Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.
Perspectives and experiences of healthcare professionals participating in the FP-AF program through interviews.
Measured: Intervention group: End of telerehabilitation (16 weeks)
Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.
Perspectives and experiences of healthcare professionals participating in the FP-AF program by observation of use of Heartportal
Measured: Intervention group: End of telerehabilitation (16 weeks)
Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care
Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care assessed by data from EPR and databases at Region Midt \& Viborg, Skive and Silkeborg Municipalities.
Measured: Both intervention and control group: at the end of telerehabilitation (16 weeks)
Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care
Measured by European Quality og life - 5 Dimensions (EQ-5D) questionnaire. The questionaire is used to assess HRQoL and is comprised of 5 questions ranging from 1-5, with a lower score indicating a better outcome, and a higher score indicating a worse outcome. The questionnaire also has a question ranging from 0-100, with a lower score indicating a worse outcome and a higher score indicating a better outcome. The maximum score a patient can achieve in the questionnaire is 1, which indicates the best health state.
Measured: Both intervention and control group: At the end of telerehabilitation (16 weeks) and at end follow up (28 weeks)
Patterns in multiparametric clinical monitoring
Data from devices for measuring blood pressure (mmHG) (systolic and diastolic) to analyze and identify correlations in multiparametric data.
Measured: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Data from devices for measuring steps to analyze and identify correlations in multiparametric data.
Measured: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Data from devices for measuring Electrocardiogram (ECG) to analyze and identify correlations in multiparametric data.
Measured: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Data from devices for measuring weight (kilograms) to analyze and identify correlations in multiparametric data.
Measured: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Data from devices for measuring pulse (numbers per minute) to analyze and identify correlations in multiparametric data.
Measured: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Data from devices for measuring sleep (numbers of hours per night) to analyze and identify correlations in multiparametric data.
Measured: Intervention group: At the end of telerehabilitation (16 weeks).
Future governance and infrastructure for telerehabilitation of AF patients
Interviews with patients and stakeholders
Measured: Intervention group: At the end of telerehabilitation (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Cardiology, Viborg Regional Hospital, Department of Cardiology, Silkeborg Regional Hospital, Center for Innovative Medical Technologies (CIMT), Odense University Hospital, Laboratory for Welfare Technology, Department of Health Science and Technology, Aalborg University
- Responsible party
- Principal investigator, Birthe Dinesen, Aalborg University
- Investigators
- Birthe Dinesen, MSc, Ph.D, Principal investigator, Aalborg UniversityDorthe Svenstrup, MD, Ph.D, Study director, Central Jutland Regional Hospital, ViborgLars Frost, MD, Ph.D, DMSc, Study director, Central Jutland Regional Hospital, Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101485
- Sponsor's protocol ID
- N-20220056
- Acronym
- (FP-AF)
- Status last verified
- Oct 2023
- First submitted
- 26 Jun 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing protocol as we are applying for patent.
Publications
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.
PubMed 39965197
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Patient - Telerehabilitering af Patienter Med Atrieflimren (FP-AF)
- ClinicalTrials.gov ID
- NCT06101485
- Acronym / sponsor ID
- (FP-AF) / N-20220056
- Conditions
- Atrial Fibrillation
- Keywords
- Telerehabilitation, Quality of life, Cardiac patients, Atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Department of Cardiology, Viborg Regional Hospital, Department of Cardiology, Silkeborg Regional Hospital, Center for Innovative Medical Technologies (CIMT), Odense University Hospital, Laboratory for Welfare Technology, Department of Health Science and Technology, Aalborg University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Oct 2023 (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.
This project has focus on patients with atrial fibrillation testing a telerehabilitation program for patients with atrial fibrillation.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Device: TelerehabilitationThe 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. |
| 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. |
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 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
Key exclusion criteria (3 listed)
- Pregnancy
- Refusal or inability to cooperate; or patient not does not speak, read or understand Danish
- Life expectancy less than a year
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 |
|---|---|---|
| TelerehabilitationTelerehabilitation 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) | Device | Telerehabilitation group |
Primary outcome
Changes in AF specific health-related quality of life
Time frame: For both intervention and control group: QoL will be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks
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
25 secondary outcomes
Changes in AF knowledge
Time frame: For both intervention and control group: To be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks
Measurement of weight
Time frame: Intervention group: Weight will be measured at baseline, twice a week, and as needed up to 16 weeks
Measurement of bloodpressure
Time frame: Intervention group: Bloodpressure will be measured at baseline, twice a week, and as needed up to 16 weeks
Measurement of pulse
Time frame: Intervention group: Pulse will be measured at baseline, everyday, and as needed up to 16 weeks
Measurement of steps
Time frame: Intervention group: Steps will be measured from the date of randomization, everyday to end follow up (28 weeks)
Measurement of sleep
Time frame: Intervention group: Sleep will be measured every day up to 16 weeks
Measurement of heart rhythm
Time frame: Intervention group: ECG wil be measured at baseline, twice a week, and as needed up to 16 weeks
Changes in anxiety and depression
Time frame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Changes in motivation
Time frame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Changes in motivation
Time frame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Changes in motivation
Time frame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Burden of AF
Time frame: Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.
Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)
Time frame: Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks)
Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)
Time frame: Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks)
Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.
Time frame: Intervention group: End of telerehabilitation (16 weeks)
Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.
Time frame: Intervention group: End of telerehabilitation (16 weeks)
Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care
Time frame: Both intervention and control group: at the end of telerehabilitation (16 weeks)
Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care
Time frame: Both intervention and control group: At the end of telerehabilitation (16 weeks) and at end follow up (28 weeks)
Patterns in multiparametric clinical monitoring
Time frame: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Time frame: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Time frame: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Time frame: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Time frame: Intervention group: At the end of telerehabilitation (16 weeks).
Patterns in multiparametric clinical monitoring
Time frame: Intervention group: At the end of telerehabilitation (16 weeks).
Future governance and infrastructure for telerehabilitation of AF patients
Time frame: Intervention group: At the end of telerehabilitation (16 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 39965197Dinesen 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.
- Read more about the trial at the homepage for the Laboratory for Welfare Technology - Digital health \& rehabilitation, Aalborg UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan for sharing protocol as we are applying for patent.
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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.
Birthe Dinesen, MSc, Ph.D principal investigator
Aalborg University
Dorthe Svenstrup, MD, Ph.D study director
Central Jutland Regional Hospital, Viborg
Lars Frost, MD, Ph.D, DMSc study director
Central Jutland Regional Hospital, Silkeborg
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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birthe Dinesen, MSc, Ph.D (004520515944, bid@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in AF specific health-related quality of life (time frame: For both intervention and control group: QoL will be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks). 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 NCT06101485, 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 26 Oct 2023.