Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)

Atrial Fibrillation and Flutter Clinical Trial

— AF-EduApp  

Official title:

Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788044
• Other study ID #: AF-EduApp / EC 18/12/171
• Secondary ID: CV185-696
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate a new and innovative educational application based on targeted education on the adherence level for NOACs (non-vitamin K antagonist oral anticoagulants) in AF patients, compared with standard care, online targeted education and in-person targeted education.

Several other parameters (knowledge level, quality of life, symptom burden, self-care capabilities, evaluation of educational efforts) will be studied. If resources allow, cardiovascular outcomes, cost-effectiveness and cost-utility will also be investigated.

Description:

This substudy is part of the AF-EduCare study (NCT03707873): an extra study arm will be added to the main trial in which eligible AF patients (= in possession of a smartphone and capable working with their smartphone) will test this new educational application. Not eligible patients randomized to this group, will receive standard care.

This extra study arm will additionally include an anticipated 221 patients (eligible plus not eligible patients).

[An anticipated total of 1259 AF patients will be included for the AF-EduCare study (1038 AF patients) plus the AF-EduApp substudy (221 AF patients).]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• 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

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Bristol-Myers Squibb, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The first occurrence of a cardiovascular event	The first occurrence of a composite of cardiovascular death, a first cardiovascular hospitalization (i.e. hospitalization with overnight stay) and a first unplanned cardiovascular or neurological visit.	Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Mortality	The occurrence of death will be followed.	Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Number of (un)planned hospital admissions		Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Hospital duration		Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Number of (un)planned cardiovascular and neurological visits		Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Number of cardiovascular emergency department visits		Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	General practitioner visits		Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Exact time investments (in minutes)	Time investments will be tracked (e.g. timing of the initiation session, the education sessions, feedback during medication telemonitoring, time spended on the application time and content usage).	Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Cost-utility analysis	In all groups, the economic impact of hospitalizations, consultations, emergency department visits will be calculated using all relevant costs of inpatient and outpatient diagnostic/interventional procedures, based on the mean of hospital bills of each participating hospital. Since quality of life is evaluated throughout the trial, a cost-utility analysis will be performed.	Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Other	Cost-effectiveness analysis	In all groups, the economic impact of hospitalizations, consultations, emergency department visits will be calculated using all relevant costs of inpatient and outpatient diagnostic/interventional procedures, based on the mean of hospital bills of each participating hospital. With this data, a cost-effectiveness analysis will be performed.	Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Primary	Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).		Monitored between 0-12 months and 12-15 months if resources allow.
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 months in the application group.(+18-and if applicable at 24-,30-,36 months/at the end of the study in the other intervention groups).In the standard care groups at 12 or 18 months (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).	at baseline, 3- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).
Secondary	Patients' quality of life, assessed by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.	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 and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 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- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 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- and 12 months in the application group. (+18-and if applicable 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).
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 all intervention groups and 12 or 18 months in the standard care groups.