Assessment of Validity and Reliability of the Turkish Version of the Quality of Life and Related Events Assessment Scale for Pacemaker Patients

Cardiac implantable electronic devices are widely utilized to lower the rates of morbidity and mortality from ventricular tachycardia and ventricular fibrillation, as well as the incidence of sudden cardiac death. Although implantation of these devices increases survival rates, patients may experience acute and chronic complications. These complications include device dislocation and fracture, inappropriate shocks, pocket hematoma, or infection. Furthermore, functional loss in the upper extremity may result from upper extremity restrictions that are applied for an excessively long time in order to ensure proper placement of the device following implantation, or from patients who choose to extend this period on their own initiative out of worry about device failure or dislocation. Patients' quality of life may be negatively impacted by these issues as well as diminished exercise capacity, weariness, and weaker respiratory and peripheral muscles. A quality of life scale called 'The Assessment of Quality of Life and Related Events (AQUAREL)' was developed by Stoffmel et al. for patients using pacemakers. In this study, the validity and reliability study of the Turkish version of the AQAREL Scale will be conducted.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Cardiac Implantable Electronic Devices
• Intervention / Treatment: Other: Cardiac implantable electronic devices

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: GAMZE NUR AHISKALI, MsC; Phone Number: +90 551 412 86 87; Email: gmzahiskali@gmail.com

Study Locations

• Turkey (Türkiye)
  • Center
    • Çorum, Center, Turkey (Türkiye), 19000
      • Recruiting
      • Hitit University Çorum Erol Olçok Training and Research Hospital
      • Contact: Gamze N Ahıskalı, master; Phone Number: +905514128687; Email: gmzahiskali@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

participant with cardiac implantable electronic devices between the ages of 18-65

Description

Inclusion Criteria:

• Having a pacemaker implant and not having any complications at the last pacemaker check-up,

  • Being in NYHA I-II-III-IV class,
  • Patients with no cooperation problems,
  • Volunteering to participate in the study.

Exclusion Criteria:

• • Patients with insufficient dementia or cognitive impairment due to multiple comorbidities (e.g., recent cerebrovascular accident and/or significant hypotension),

  • Patients with a history of psychiatric illness,
  • Patients with speech, hearing or intellectual disabilities.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turkish adaptation of the scale assessing quality of life	The Assessment of Quality of Life And RELated Events (AQUAREL) scale, which was created especially for people with cardiac implanted electronic devices, will be translated into Turkish. / The total score ranges from 0 to 100. A low score reflects poor health perception, loss of function and presence of pain, while a high score reflects good health perception, preserved function and absence of pain.	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of quality of life	Short Form- 36 -SF-36 Life Questionnaire / Each sub-parameter is scored between 0 and 100. A high score indicates that the individual has a high quality of life.	1 year
Evaluation of quality of life	MacNew Heart Disease Health-Related Quality of Life Questionnaire / The questions are scored from 1 to 7, with higher scores indicating better quality of life.	1 year
Evaluation of activities of daily living	Performance Measure for Activities of Daily Living-8 for Patient with Mild Symptomatic Heart Failure- PMADL-8 / The total score ranges from 8-32, with a high score indicating a level of limitation in activities of daily living.	1 year
Evaluation of comorbidity level	Modified Charlson Comorbidity İndex (CCI) / Comorbidity classification is low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7) and very high comorbidity (score ≥ 8). High score indicates high mortality rates.	1 year

Collaborators and Investigators

• Sponsor: Erol Olcok Corum Training and Research Hospital
• Collaborators: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; patient reported outcomes; cardiac implantable electronic devices
• Other Study ID Numbers: 2024-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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