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

Recruiting

• Conditions: Cardiac Implantable Electronic Devices; Quality of Life

• Registration Number: NCT06775223
• Lead Sponsor: Erol Olcok Corum Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Study First Submitted: 2024-09-10
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Turkish adaptation of the scale assessing quality of life	1 years	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of quality of life	1 year	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.
Evaluation of activities of daily living	1 year	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.
Evaluation of comorbidity level	1 year	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.

Trial Locations

Locations (1)

Hitit University Corum Erol Olçok Training and Research Hospital; 🇹🇷 Çorum, Center, Turkey