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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123327
• Other study ID #: Cross-sectional AF
• Status: Completed
• Start date: December 24, 2019
• Est. completion date: October 10, 2020

Study information

• Verified date: February 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 10, 2020
• Est. primary completion date: October 10, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• Diagnoses with AF

• Able to read Swedish and access to computer

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Sweden	Department of Clinical Neuroscience, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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	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
Secondary	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
Secondary	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
Secondary	Anxiety Sensitivity Index (ASI)	Measure of anxiety sensitivity	Baseline
Secondary	Bodily Sensation Questionnaire (BSQ)	Fear of bodily sensations	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	AF behaviors	Checklist of behaviors related to AF	Baseline
Secondary	Demographics	Demographics	Baseline
Secondary	Medical history	Comorbidities, medication, medical history	Baseline