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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04123327
Enrollment
400
Registered
2019-10-10
Start date
2019-12-24
Completion date
2020-10-10
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Symptom preoccupation, Atrial fibrillation, Quality of Life, Cardiac anxiety

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.

Interventions

None listed

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
[Time Frame: From baseline to 12 weeks] Atrial Fibrillation Effect on Quality-of-Life (AFEQT)BaselineAFEQT 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

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)BaselineMeasures 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)BaselineThe 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)BaselineMeasure of anxiety sensitivity
Bodily Sensation Questionnaire (BSQ)BaselineFear of bodily sensations
The University of Toronto Atrial Fibrillation Severity Scale (AFSS)BaselineAFSS 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.
Cardiac Anxiety Questionnaire (CAQ)BaselineIt 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.
Perceived Stress Scale (PSS-4)BaselineTo 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)BaselineWHODAS 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 behaviorsBaselineChecklist of behaviors related to AF
DemographicsBaselineDemographics
Medical historyBaselineComorbidities, medication, medical history
The Symptoms Checklist, Frequency and Severity Scale (SCL)BaselineSCL 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026