Symptom Preoccupation in Atrial Fibrillation (AF) and Its Role in AF-related Disability

Study Overview
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Brief Summary
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A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

Detailed Description
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In the present study we aim to investigate symptom preoccupation in patients with atrial fibrillation (AF) to further improve the understanding of the role of psychological factors in AF-related disability. A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

Official Title
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The Prevalence of Symptom Preoccupation and Its Role in AF-related Disability

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age Diagnoses with AF Able to read Swedish and access to computer Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Time Frame: From baseline to 12 weeks] Atrial Fibrillation Effect on Quality-of-Life (AFEQT) | AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. The scale has 20 items, with the total score ranging from 0 (severe symptoms and disability) to 100 (no symptoms and disability), with responses provided on a seven-point rating scale from no limitations/symptoms to severe limitations/symptoms. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Anxiety Questionnaire (CAQ) | It an 18-item scale that measures cardiac anxiety by three subscales fear (e.g., When my heart is beating fast I get frightened avoidance (e.g., I avoid exercise or other physical work) and attention (e.g., I pay attention to my heart beat). The responses are given on a four-point Likert scale ranging from 0 (never) to 4 (always), a greater score indicates greater cardiac anxiety. | Baseline | 
| Patient Health Questionnaire (PHQ-9) | Measures depressive symptoms on nine items scoring from 0 (not at all) to 3 (nearly every day) per item. Scores were categorized as follows: zero to minimal depressive symptoms (0-4), mild to moderate depressive symptoms (5-10), or severe depressive symptoms (10 or above). | Baseline | 
| The Generalized Anxiety Disorder (GAD-7) | The Generalized Anxiety Disorder (GAD-7) scale measures the severity of worry and anxiety. In healthy controls, the mean score was 4.9 (SD=4.8); a score of 10 or greater on the scale corresponds to a cut-off point for identifying cases of GAD. | Baseline | 
| Anxiety Sensitivity Index (ASI) | Measure of anxiety sensitivity | Baseline | 
| Bodily Sensation Questionnaire (BSQ) | Fear of bodily sensations | Baseline | 
| The University of Toronto Atrial Fibrillation Severity Scale (AFSS) | AFSS will assess AF symptoms and how affected the patient is by AF-specific symptoms such as dyspnea, palpitations etc. The AF symptom score ranges from 0-35 with a higher score indicating higher symptom severity. | Baseline | 
| The Symptoms Checklist, Frequency and Severity Scale (SCL) | SCL is a disease specific checklist used to measure AF-related symptoms (e.g., palpitations, dizziness) on two subscales: symptom severity (mild to extreme; 16 items, scores ranging from 0 to 48) and symptom frequency (never to always; 16 items, scores ranging from 0 to 64) over the past four weeks. Higher scores correlate with more frequent and severe symptoms. | Baseline | 
| Perceived Stress Scale (PSS-4) | To assess stress sensitivity and perception of stress. Each item is rated on a five-point scale and a higher score corresponds to more perceived stress. | Baseline | 
| World Health Organization Disability Assessment Schedule (WHODAS) | WHODAS is a reliable and well validated measure of general health and disability. We use the version consisting of 12-items evaluating six domains: cognition, mobility, self-care, getting along, life activities and life participation. Each item is rated on a 5-point scale, with higher scores indicating increased disability. | Baseline | 
| AF behaviors | Checklist of behaviors related to AF | Baseline | 
| Demographics | Demographics | Baseline | 
| Medical history | Comorbidities, medication, medical history | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom preoccupation, Atrial fibrillation, Quality of Life, Cardiac anxiety