NCT04123327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 24, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

October 9, 2019

Last Update Submit

February 17, 2021

Conditions

Atrial Fibrillation

Keywords

Symptom preoccupationAtrial fibrillationQuality of LifeCardiac anxiety

Outcome Measures

Primary Outcomes (1)

  • [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 Outcomes (12)

  • Cardiac Anxiety Questionnaire (CAQ)

    Baseline

  • Patient Health Questionnaire (PHQ-9)

    Baseline

  • The Generalized Anxiety Disorder (GAD-7)

    Baseline

  • Anxiety Sensitivity Index (ASI)

    Baseline

  • Bodily Sensation Questionnaire (BSQ)

    Baseline

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brjánn Ljótsson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 10, 2019

Study Start

December 24, 2019

Primary Completion

October 10, 2020

Study Completion

October 10, 2020

Last Updated

February 18, 2021

Record last verified: 2020-02

Locations

SE(1)