NCT04047381

Brief Summary

Validity and reliability of the Turkish version of 'Atrial Fibrillation Impact Questionnaire (AFImpact)' will be evaluated in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

August 5, 2019

Last Update Submit

October 21, 2019

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationQuality of life

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation Impact Questionnaire (AFImpact)

    AFImpact is a 18-item disease specific questionnaire that enables respondents to recall how often their atrial fibrillation affected their lives over the past seven days. Each item is scored on a seven-point likert scale (between 0 and 6 point, 6 point is being the most frequent). Higher scores indicate poorer quality of life.

    5 minutes

Secondary Outcomes (2)

  • Short-form 36 (SF-36)

    10 minutes

  • Pittsburgh Sleep Quality Index

    5 minutes

Study Arms (1)

Atrial Fibrillation

Turkish patients diagnosed with atrial fibrillation

Other: Measurement of Quality of Life

Interventions

Measurement of Quality of LifeOTHER

Quality of life will be measured using Atrial Fibrillation Impact Questionnaire, Short Form-36 and Pittsburgh Sleep Quality Index

Atrial Fibrillation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Turkish patients diagnosed with atrial fibrillation

You may qualify if:

  • Diagnosis of paroxysmal, persistant or permanent atrial fibrillation
  • To be able to read and understand Turkish

You may not qualify if:

  • Diagnosis of heart failure or any chronic lung diseases
  • Recent coronary bypass surgery
  • Previous heart valve surgery
  • Rheumatic valvular heart disease
  • Recent acute myocardial infarction
  • Having a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University- Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 6, 2019

Study Start

August 8, 2019

Primary Completion

October 21, 2019

Study Completion

October 21, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

TU(1)