Future Patient - Telerehabilitation of Patients With Atrial Fibrillation ((FP-AF))

October 24, 2023 updated by: Birthe Dinesen, Aalborg University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Birthe Dinesen, MSc, Ph.D
  • Phone Number: 004520515944
  • Email: bid@hst.aau.dk

Study Contact Backup

  • Name: Dorthe Svenstrup, MD, Ph.D
  • Phone Number: 004578447051
  • Email: dorthmoe@rm.dk

Study Locations

  • Denmark
      • Viborg And Silkeborg, Denmark
        • Recruiting
        • Central Jutland Regional Hospital
        • Contact:
          • Dorthe Svenstrup, MD, Ph.D
          • Phone Number: 004578447051
          • Email: dorthmoe@rm.dk
        • Principal Investigator:
          • Lars Frost, MD, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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)
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
For both intervention and control group: QoL will be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
Intervention group: Weight (Kilograms)
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
Intervention group: Bloodpressure (mmHG) (systolic and diastolic)
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
Intervention group: Pulse (numbers per minute)
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)
Intervention group: numbers of steps taken
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
Intervention group: Sleep (numbers of hours per night)
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
Intervention group: Electrocardiogram (ECG)
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.
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)
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 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.
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 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'.
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 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'.
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.
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.
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)
Perspectives and experiences of patients and relatives participating in the FP-AF program (including the Heartportal) measured by interviews with patients and relatives.
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)
Patients and relatives use of HeartPortal measured in logfiles on use & via observation in everyday life
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)
Perspectives and experiences of healthcare professionals participating in the FP-AF program through interviews.
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)
Perspectives and experiences of healthcare professionals participating in the FP-AF program by observation of use of Heartportal
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 assessed by data from EPR and databases at Region Midt & Viborg, Skive and Silkeborg Municipalities.
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)
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.
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).
Data from devices for measuring blood pressure (mmHG) (systolic and diastolic) to analyze and identify correlations in multiparametric data.
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).
Data from devices for measuring steps to analyze and identify correlations in multiparametric data.
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).
Data from devices for measuring Electrocardiogram (ECG) to analyze and identify correlations in multiparametric data.
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).
Data from devices for measuring weight (kilograms) to analyze and identify correlations in multiparametric data.
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).
Data from devices for measuring pulse (numbers per minute) to analyze and identify correlations in multiparametric data.
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).
Data from devices for measuring sleep (numbers of hours per night) to analyze and identify correlations in multiparametric data.
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)
Interviews with patients and stakeholders
Intervention group: At the end of telerehabilitation (16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Center for Innovative Medical Technologies (CIMT), Odense University Hospital
Department of Cardiology, Viborg Regional Hospital
Department of Cardiology, Silkeborg Regional Hospital
Laboratory for Welfare Technology, Department of Health Science and Technology, Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Birthe Dinesen, MSc, Ph.D, Aalborg University
  • Study Director: Dorthe Svenstrup, MD, Ph.D, Central Jutland Regional Hospital, Viborg
  • Study Director: Lars Frost, MD, Ph.D, DMSc, Central Jutland Regional Hospital, Silkeborg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N-20220056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan for sharing protocol as we are applying for patent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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