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Validity and Reliability of the Turkish Version of Atrial Fibrillation Impact Questionnaire (AFImpact)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047381
Recruitment Status : Completed
First Posted : August 6, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Istanbul University-Cerrahpasa
Information provided by (Responsible Party):
Melih Zeren, Bezmialem Vakif University

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

Condition or disease Intervention/treatment
Atrial Fibrillation Other: Measurement of Quality of Life

Detailed Description:
Atrial fibrillation (AF) is the most common sustained arrhythmia with a reported incidence of 2.1% in Turkish population aged 60 and above. Although a minority of patients have minimal or no symptoms, palpitations, dyspnea and fatigue are frequently reported by AF patients. It is well documented that AF patients, including those with no symptoms, have poorer quality of life (QoL) compared to healthy population. Worrying about their condition, side effects of treatments and worsening health are the other factors that have an impact on QoL, beside symptoms. Management of QoL is a key therapeutic goal in AF treatment and guidelines recommend that QoL in these patients should be measured regularly. There is a concern in the literature that generic QoL measures may not be sufficiently sensitive or specific to measure AF related QoL, thus using disease specific QoL measures are recommended for AF patients. An AF-specific quality of life measure is lacking in Turkish language, thus our aim in this study is to validate the Turkish version of 'Atrial Fibrillation Impact Questionnaire (AFImpact)' in Turkish AF patients.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validity and Reliability of the Turkish Version of Atrial Fibrillation Impact Questionnaire (AFImpact)
Actual Study Start Date : August 8, 2019
Actual Primary Completion Date : October 21, 2019
Actual Study Completion Date : October 21, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atrial Fibrillation
Turkish patients diagnosed with atrial fibrillation
Other: Measurement of Quality of Life
Quality of life will be measured using Atrial Fibrillation Impact Questionnaire, Short Form-36 and Pittsburgh Sleep Quality Index




Primary Outcome Measures :
  1. Atrial Fibrillation Impact Questionnaire (AFImpact) [ Time Frame: 5 minutes ]
    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.


Secondary Outcome Measures :
  1. Short-form 36 (SF-36) [ Time Frame: 10 minutes ]
    SF-36 is a generic quality of life questionnaire that is widely used in clinical research. It consists of 36 items and yields an 8-scale profile of functional health and well-being scores as well as two summary scores of physical and mental health. A higher score on a 0-100 scale indicates a better quality of life.

  2. Pittsburgh Sleep Quality Index [ Time Frame: 5 minutes ]
    Pittsburgh Sleep Quality Index is a 24-item questionnaire that assess subjective sleep quality over the past month. It consists of seven clinical domains which are also pooled linearly to get a global score.Each item is scored on a 0-3 likert scale and higher scores indicate worse sleep quality.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Turkish patients diagnosed with atrial fibrillation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047381


Locations
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Turkey
Istanbul University- Cerrahpasa, Institute of Cardiology
Istanbul, Turkey
Sponsors and Collaborators
Bezmialem Vakif University
Istanbul University-Cerrahpasa

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Responsible Party: Melih Zeren, Assistant Professor, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04047381    
Other Study ID Numbers: bvumzeren03
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melih Zeren, Bezmialem Vakif University:
Atrial fibrillation
Quality of life
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes