Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation

Study Overview
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Brief Summary
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The aim is to investigate whether optimizing patients' expectations towards the interventional treatment of atrial fibrillation (catheter ablation) leads to a lower disease-related impairment of the patients compared to the control group in the first three months after ablation (the so-called blanking period).

Official Title
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Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Expectation optimization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic atrial fibrillation indication for pulmonary vein isolation sufficient command of the German language Exclusion Criteria: age <18 years permanent atrial fibrillation presence of psychiatric disorders which impair the study participitatin presence of another medical condiction which influences quality of life stronger than the cardiac condition atrial fibrillation induced by intoxication, medicamentation or infection inability to grap the course of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Medical Care Control Group<br>Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention. | |
| Experimental: Optimize Expectation Group<br>Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation and an additional verbal intervention to optimize the expectation of the patient towards the procedure. | Other: Expectation optimization<br>* A short (2-5 min) verbal intervention will be createad individually based on the expectation of the patient towards the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (questionaire) | Quality of life of life will be compared between groups and between different time points (before versus 3 months after ablation) with the atrial fibrillation effect on quality-of-life (AFEQT) questionnaire. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding not at all limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial arrhythmias | Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec | 3 months | 
| Recurrence of atrial arrhythmias | Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec | 12 months | 
| Autonomic function (heart rate variability measurement) | Autonomic function will be assessed by heart rate variability measurement (low frequency and high frequency domain, root mean square of successive differences) to compare patients between groups and time points (before versus 3 months after ablation) | 3 months | 
| Atrial volume [ml/m2] | Atrial volume measured via echocardiography will be compared between groups and time points (before versus 3 months after ablation) | 3 months | 
| Left ventricular ejection fraction [%] | Left ventricular ejection fraction measured via echocardiography will be compared between groups and between time points (before versus 3 months after ablation) | 3 months | 
| Inflammatory markers from blood samples | Inflammatory markers (including IFN-gamma, TNF-alpha TGF-beta, IL-1beta, IL-4, IL-6, IL-8, IL-10, IL-1, CRP, MPO, NGF, S100B, ANP, FABP4) in blood samples measured via enzyme-linked immunosorbent assays will be compared between groups and between time points (before versus 3 months after ablation) | 3 months | 
| Treatment expectations (questionaire) | Treatment expectations will be measured using the GEEE (Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects) questionaire by Rief et al. and compared between groups and between time points (before versus 3 months after ablation / before versus 12 months after ablation). The subscale Generic rating scale for treatment expectations consists of three items that assess expectations towards treatment on a numeric rating scale with eleven response options (0-10); total scores of all three subscales combined range from 0-30 with higher scores indicating higher treatment expectations. | 3 months, 12 months | 
| Physical Activity (questionaire) | Physical activity will be measured will be compared between groups and time points (before versus 3 months after ablation) using the short version of the International Physical Activity Questionnaire (IPAQ - short). The short version of the IPAQ is a 7-item questionnaire that assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. Open-ended questions surrounding individuals' last 7-day recall of physical activity are considered to estimate total physical activity min/week and time spent sitting. Interpretation: Three levels (categories) of physical activity are proposed: low, moderate and high. | 3 months, 12 months | 
| General quality of life (questionaire) | General quality of life of life will be compared between groups and between different time points (before versus 3 months after ablation) with F-36 questionaire. SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. | 3 months, 12 months | 
| Hospital Anxiety and Depression Scale HADS (questionaire) | Hospital anxiety and depression will becompared between groups and time points (before versus 3 months after ablation) using the Hospital Anxiety and Depression Scale (HADS). It consists of 14 items rated zero to three on Likert scales, allowing computation of sub-scores for depression and anxiety symptoms. Subscores as well as total sum score will be applied. | 3 months, 12 months | 
| Cardiac Anxiety Questionnaire CAQ (questionaire) | Cardiac anxiety will becompared between groups and time points (before versus 3 months after ablation) using the established Cardiac Anxiety Questionnaire CAQ to determine cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 68 for the German version, with a greater score indicating elevated cardiac anxiety. | 3 months, 12 months |