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

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: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Telerehabilitation

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: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	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)	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	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)	Intervention group: Sleep will be measured every day up to 16 weeks
Measurement of heart rhythm	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	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	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	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	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	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)	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)	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.	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.	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	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	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	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	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	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	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	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	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	Interviews with patients and stakeholders	Intervention group: At the end of telerehabilitation (16 weeks)

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: 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: 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

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Quality of life; Telerehabilitation; Cardiac patients
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID 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