Effect of Targeted Education for Atrial Fibrillation Patients

Atrial Fibrillation and Flutter Clinical Trial

— AF-EduCare  

Official title:

Effect of Targeted Education for Atrial Fibrillation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707873
• Other study ID #: AF-EduCare / EC 18/12/171
• Secondary ID: T002917N
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation and Flutter

Intervention

Other:
• Education
Education + Medication adherence monitoring + Feedback when low adherence

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem
Belgium	Jessa Hospital	Hasselt
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time investments	Time investments will be tracked (e.g. timing of the initiation session, the education sessions, feedback during medication telemonitoring).	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Other	Cost-utility analysis	A cost-utility analysis will be performed.	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Other	Cost-effectiveness analysis	A cost-effectiveness analysis will be performed.	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Primary	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).	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary	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).	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).		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
Secondary	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.	at 12 months in the intervention groups and 18 months in the standard care group.
Secondary	Mortality	The occurrence of death will be followed.	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary	(Un)planned hospital admissions		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary	Hospital duration	The total number of hospitalization days during the follow-up period will be calculated.	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary	(Un)planned cardiovascular and neurological visits		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary	Cardiovascular emergency department visits		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary	General practitioner visits		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).