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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047381
• Other study ID #: bvumzeren03
• Status: Completed
• Start date: August 8, 2019
• Est. completion date: October 21, 2019

Study information

• Verified date: October 2019
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa, Institute of Cardiology	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Short-form 36 (SF-36)	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.	10 minutes
Secondary	Pittsburgh Sleep Quality Index	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.	5 minutes