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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Measurement of Quality of Life

• Registration Number: NCT04047381
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Study Start: 2019-08-08
• Status Verified: 2019-10
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial Fibrillation	Measurement of Quality of Life	Turkish patients diagnosed with atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation Impact Questionnaire (AFImpact)	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

Name	Time	Method
Short-form 36 (SF-36)	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.
Pittsburgh Sleep Quality Index	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.

Trial Locations

Locations (1)

Istanbul University- Cerrahpasa, Institute of Cardiology; 🇹🇷 Istanbul, Turkey