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Effect of Targeted Education for Atrial Fibrillation Patients (AF-EduCare)

Primary Purpose

Atrial Fibrillation and Flutter

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Education
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation and Flutter focused on measuring Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,…)
  3. Patients who are capable to sign the informed consent.

Exclusion Criteria:

  1. Not able to speak and read Dutch
  2. Cognitive impaired (e.g. severe dementia)
  3. Life expectancy is estimated to be less than 1 year.
  4. Ongoing participation in another clinical trial.
  5. Pregnant women

Sites / Locations

  • Antwerp University Hospital
  • Jessa Hospital
  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

In-person education

Online education

Standard Care

Arm Description

Education will be given on a regular basis via predefined consultation visits. Medication adherence (oral anticoagulation) will also be measured using a special cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.

Education will be given on a regular basis via a special designed online platform. Medication adherence (oral anticoagulation) will also be measured using a special cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.

This group of AF patients will serve as a control group and no extra focused educational reinforcements will be provided beyond standard care (i.e. information of the treating physician and a brochure).

Outcomes

Primary Outcome Measures

Cardiovascular events
The occurrence of a composite endpoint of cardiovascular death, cardiovascular hospitalizations (first and recurrent) and unplanned cardiovascular or neurological consultations (first and recurrent).

Secondary Outcome Measures

Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)
This questionnaire includes 16 knowledge questions: 8 about atrial fibrillation, 5 about oral anticoagulation medication and 3 about vitamine K antagonists or non-vitamin K antagonist oral anticoagulants. A total score between 0% and 100% will be generated in which 100% is the best possible score (all questions are answered correctly).
Patients' quality of life, assessed by the EQ-5D-3L questionnaire and the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.
The EQ-5D-3L descriptive system includes a total of 5 questions for 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each question has 3 levels (no problems, some problems, and extreme problems). The EQ Visual Analogue Scale records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). The AFEQT is an atrial fibrillation-specific health-related quality of life questionnaire based on 18 questions in the domain of symptoms, daily activities and treatment concerns. A treatment satisfaction score can be calculated based on 2 additional questions. All questions are rated on a 7 point Likert scale. A scoring key is used to determine an overall AFEQT score and a treatment satisfaction score ranging from 0 to 100. A lower score indicates a worse health-related quality of life.
Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).
The LARQ is based on 6 atrial fibrillation-related symptoms: palpitations, shortness of breath, chest pain, syncope, dizziness and fatigue. For each of these symptoms (except syncope), symptom prevalence, occurrence (frequency, duration, severity), distress, circumstances triggering the symptom, and effect on daily activities are requested. Subscale scores on five domains (symptom frequency, duration, effect on daily activities, severity and distress) are calculated by summing the raw scores and transforming them to a 0-100 scale. Higher scores represent a more pronounced symptom burden.
Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ)
This questionnaire includes a total of 15 questions. The first 6 questions will be scored on a 1 to 5 Likert scale. 1 is the best score and 5 is the worst score. The other 9 questions measure evolutions of self-care capabilities over time.
Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).
Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.
The number of questions will depend on the specific group allocation, ranging from a minimum of 4 questions to a maximum of 20 questions. These questions assess patients' satisfaction and opinion about the education provided during the study.
Mortality
The occurrence of death will be followed.
(Un)planned hospital admissions
Hospital duration
The total number of hospitalization days during the follow-up period will be calculated.
(Un)planned cardiovascular and neurological visits
Cardiovascular emergency department visits
General practitioner visits

Full Information

First Posted
October 2, 2018
Last Updated
November 8, 2022
Sponsor
Universiteit Antwerpen
Collaborators
Fund for Scientific Research, Flanders, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT03707873
Brief Title
Effect of Targeted Education for Atrial Fibrillation Patients
Acronym
AF-EduCare
Official Title
Effect of Targeted Education for Atrial Fibrillation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Fund for Scientific Research, Flanders, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of targeted in-person and online education on cardiovascular outcomes of AF patients (inpatient and outpatient), compared with standard care. Several other parameters (i.e. knowledge level, quality of life, symptom burden, self-care capabilities, adherence to oral anticoagulation, and an evaluation of the educational efforts) will be studied. Cost-effectiveness and cost-utility will also be investigated. The main research hypothesis is that individualized education based on the knowledge gaps measured with the JAKQ (Jessa Atrial fibrillation Knowledge Questionnaire) in each individual patient (called 'targeted education') is superior when compared to current AF care, both from an efficacy perspective (evaluated by different outcome measures) and from a cost-effectiveness perspective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation and Flutter
Keywords
Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
AF patients will be divided in three groups: one group will have in-person education, the second group will have online education and the third group will receive standard AF care. Cardiovascular outcomes will be compared between these groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1040 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-person education
Arm Type
Experimental
Arm Description
Education will be given on a regular basis via predefined consultation visits. Medication adherence (oral anticoagulation) will also be measured using a special cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.
Arm Title
Online education
Arm Type
Experimental
Arm Description
Education will be given on a regular basis via a special designed online platform. Medication adherence (oral anticoagulation) will also be measured using a special cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
This group of AF patients will serve as a control group and no extra focused educational reinforcements will be provided beyond standard care (i.e. information of the treating physician and a brochure).
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Education + Medication adherence monitoring + Feedback when low adherence
Primary Outcome Measure Information:
Title
Cardiovascular events
Description
The occurrence of a composite endpoint of cardiovascular death, cardiovascular hospitalizations (first and recurrent) and unplanned cardiovascular or neurological consultations (first and recurrent).
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary Outcome Measure Information:
Title
Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)
Description
This questionnaire includes 16 knowledge questions: 8 about atrial fibrillation, 5 about oral anticoagulation medication and 3 about vitamine K antagonists or non-vitamin K antagonist oral anticoagulants. A total score between 0% and 100% will be generated in which 100% is the best possible score (all questions are answered correctly).
Time Frame
at baseline, 1 month, 3-, 6-, 12- and 18 months and if applicable at 24-, 30- and 36 months or at the end of the study in the intervention groups. In the standard care group at 18 months and if applicable at the end of the study.
Title
Patients' quality of life, assessed by the EQ-5D-3L questionnaire and the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.
Description
The EQ-5D-3L descriptive system includes a total of 5 questions for 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each question has 3 levels (no problems, some problems, and extreme problems). The EQ Visual Analogue Scale records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). The AFEQT is an atrial fibrillation-specific health-related quality of life questionnaire based on 18 questions in the domain of symptoms, daily activities and treatment concerns. A treatment satisfaction score can be calculated based on 2 additional questions. All questions are rated on a 7 point Likert scale. A scoring key is used to determine an overall AFEQT score and a treatment satisfaction score ranging from 0 to 100. A lower score indicates a worse health-related quality of life.
Time Frame
at baseline, 3-, 12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.
Title
Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).
Description
The LARQ is based on 6 atrial fibrillation-related symptoms: palpitations, shortness of breath, chest pain, syncope, dizziness and fatigue. For each of these symptoms (except syncope), symptom prevalence, occurrence (frequency, duration, severity), distress, circumstances triggering the symptom, and effect on daily activities are requested. Subscale scores on five domains (symptom frequency, duration, effect on daily activities, severity and distress) are calculated by summing the raw scores and transforming them to a 0-100 scale. Higher scores represent a more pronounced symptom burden.
Time Frame
at baseline, 3-,12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.
Title
Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ)
Description
This questionnaire includes a total of 15 questions. The first 6 questions will be scored on a 1 to 5 Likert scale. 1 is the best score and 5 is the worst score. The other 9 questions measure evolutions of self-care capabilities over time.
Time Frame
at baseline, 3-,12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.
Title
Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).
Time Frame
monitoring between 0-3 months and 12-15 months and feedback during 3-6 months and 15-18 months in those patients with a low adherence in the intervention groups
Title
Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.
Description
The number of questions will depend on the specific group allocation, ranging from a minimum of 4 questions to a maximum of 20 questions. These questions assess patients' satisfaction and opinion about the education provided during the study.
Time Frame
at 12 months in the intervention groups and 18 months in the standard care group.
Title
Mortality
Description
The occurrence of death will be followed.
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Title
(Un)planned hospital admissions
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Title
Hospital duration
Description
The total number of hospitalization days during the follow-up period will be calculated.
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Title
(Un)planned cardiovascular and neurological visits
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Title
Cardiovascular emergency department visits
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Title
General practitioner visits
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Other Pre-specified Outcome Measures:
Title
Time investments
Description
Time investments will be tracked (e.g. timing of the initiation session, the education sessions, feedback during medication telemonitoring).
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Title
Cost-utility analysis
Description
A cost-utility analysis will be performed.
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Title
Cost-effectiveness analysis
Description
A cost-effectiveness analysis will be performed.
Time Frame
Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,…) Patients who are capable to sign the informed consent. Exclusion Criteria: Not able to speak and read Dutch Cognitive impaired (e.g. severe dementia) Life expectancy is estimated to be less than 1 year. Ongoing participation in another clinical trial. Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hein Heidbuchel, MD, PhD
Organizational Affiliation
Universteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
Country
Belgium
Facility Name
Jessa Hospital
City
Hasselt
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Targeted Education for Atrial Fibrillation Patients

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