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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04123327
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Study Start: 2019-12-24
• Status Verified: 2020-02
• Primary Completion: 2020-10-10
• Study Completion: 2020-10-10
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 18 years of age
• Diagnoses with AF
• Able to read Swedish and access to computer

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[Time Frame: From baseline to 12 weeks] Atrial Fibrillation Effect on Quality-of-Life (AFEQT)	Baseline	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".

Secondary Outcome Measures

Name	Time	Method
Demographics	Baseline	Demographics
Bodily Sensation Questionnaire (BSQ)	Baseline	Fear of bodily sensations
Cardiac Anxiety Questionnaire (CAQ)	Baseline	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.
Patient Health Questionnaire (PHQ-9)	Baseline	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).
The Generalized Anxiety Disorder (GAD-7)	Baseline	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.
Anxiety Sensitivity Index (ASI)	Baseline	Measure of anxiety sensitivity
The University of Toronto Atrial Fibrillation Severity Scale (AFSS)	Baseline	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.
The Symptoms Checklist, Frequency and Severity Scale (SCL)	Baseline	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.
Perceived Stress Scale (PSS-4)	Baseline	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.
World Health Organization Disability Assessment Schedule (WHODAS)	Baseline	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.
AF behaviors	Baseline	Checklist of behaviors related to AF
Medical history	Baseline	Comorbidities, medication, medical history

Trial Locations

Locations (1)

Department of Clinical Neuroscience, Karolinska Institutet; 🇸🇪 Stockholm, Sweden