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Completed

NCT Number: NCT04123327

Symptom Preoccupation in Atrial Fibrillation (AF) 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Cardiac Anxiety Questionnaire (CAQ)

    Time frame: 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.

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: 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).

  3. The Generalized Anxiety Disorder (GAD-7)

    Time frame: 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.

  4. Anxiety Sensitivity Index (ASI)

    Time frame: Baseline

    Measure of anxiety sensitivity

  5. Bodily Sensation Questionnaire (BSQ)

    Time frame: Baseline

    Fear of bodily sensations

  6. The University of Toronto Atrial Fibrillation Severity Scale (AFSS)

    Time frame: 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.

  7. The Symptoms Checklist, Frequency and Severity Scale (SCL)

    Time frame: 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.

  8. Perceived Stress Scale (PSS-4)

    Time frame: 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.

  9. World Health Organization Disability Assessment Schedule (WHODAS)

    Time frame: 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.

  10. AF behaviors

    Time frame: Baseline

    Checklist of behaviors related to AF

  11. Demographics

    Time frame: Baseline

    Demographics

  12. Medical history

    Time frame: Baseline

    Comorbidities, medication, medical history

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2019
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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