Back to results

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

Primary Purpose

Atrial Fibrillation and Flutter

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Education

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Antwerp University Hospital
Jessa Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Application-driven education (AF-EduApp substudy)

In-person education (AF-EduCare study)

Online education (AF-EduCare study)

Standard care (AF-EduCare study and AF-EduAppsub study)

Arm Description

Education will be given via a newly developed application. Medication adherence (oral anticoagulation) will be measured using a special bottle cap that fits on a medication bottle. The patients in this group will receive feedback (notification and/or alarm) during the entire study period via this application when these patients have to take their medication.

Education will be given on regular basis via predefined consultation visits. Medication adherence (oral anticoagulation) will also be measured using a special bottle 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 regular basis via a special designed online platform. Medication adherence (oral anticoagulation) will also be measured using a special bottle 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

Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).

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).

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.

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' 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.

Full Information

NCT ID

NCT03788044

First Posted

December 5, 2018

Last Updated

November 2, 2022

Sponsor

University Hospital, Antwerp

Collaborators

Bristol-Myers Squibb, Universiteit Antwerpen

1. Study Identification

Unique Protocol Identification Number

NCT03788044

Brief Title

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

Acronym

AF-EduApp

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 28, 2019 (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

University Hospital, Antwerp

Collaborators

Bristol-Myers Squibb, Universiteit Antwerpen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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).]

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, Application, Adherence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

AF patients will be divided in four groups (AF-EduCare study and AF-EduApp substudy): one group will have application-based education (AF-EduApp substudy), the second group will have in-person education (AF-EduCare study), the third group will have online education (AF-EduCare study) and the fourth group will receive standard AF care (AF-EduCare study and not eligible for AF-EduApp substudy). NOAC adherence will be compared between these groups.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Application-driven education (AF-EduApp substudy)

Arm Type

Experimental

Arm Description

Arm Title

In-person education (AF-EduCare study)

Arm Type

Experimental

Arm Description

Arm Title

Online education (AF-EduCare study)

Arm Type

Experimental

Arm Description

Arm Title

Standard care (AF-EduCare study and AF-EduAppsub study)

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Education

Intervention Description

Education + Medication adherence monitoring + Feedback when low adherence

Primary Outcome Measure Information:

Title

Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).

Time Frame

Monitored between 0-12 months and 12-15 months if resources allow.

Secondary Outcome Measure Information:

Title

Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)

Description

Time Frame

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).

Title

Patients' quality of life, assessed by the EQ-5D-3L questionnaire and the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.

Description

Time Frame

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).

Title

Patients' quality of life, assessed by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.

Description

Time Frame

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).

Title

Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).

Description

Time Frame

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).

Title

Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ).

Description

Time Frame

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).

Title

Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.

Description

Time Frame

at 12 months in all intervention groups and 12 or 18 months in the standard care groups.

Other Pre-specified Outcome Measures:

Title

The first occurrence of a cardiovascular event

Description

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.

Time Frame