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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University- Cerrahpasa, Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Turkish patients diagnosed with atrial fibrillation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Quality of life
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: bvumzeren03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No