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

The Prevalence of Symptom Preoccupation and Its Role 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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Department of Clinical Neuroscience, Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients above 18 years of age and diagnosed with AF (paroxysmal, persistant or chronic)

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2019
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Atrial fibrillation; Symptom preoccupation; Cardiac anxiety
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Cross-sectional AF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No