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Completed

NCT Number: NCT04047381

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University- Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Measurement of Quality of Life

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2019
Registry last updated
Oct 22, 2019

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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