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

NCT06775223 | Recruiting

• 1 other identifier: 2024-29
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Implantable Electronic Devices; Quality of Life

Keywords

quality of life; patient reported outcomes; cardiac implantable electronic devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of quality of life

  1 year

• Evaluation of quality of life

  1 year

• Evaluation of activities of daily living

  1 year

• Evaluation of comorbidity level

  1 year

Interventions

Cardiac implantable electronic devices OTHER

validity and reliability study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erol Olcok Corum Training and Research Hospital: lead
• Hacettepe University: collaborator

Study Sites (1)

Hitit University Corum Erol Olçok Training and Research Hospital

Çorum, Center, 19000, Turkey (Türkiye)

RECRUITING

Central Study Contacts

GAMZE NUR AHISKALI, MsC

CONTACT

+90 551 412 86 87; gmzahiskali@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist Gamze Nur AHISKALI

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: January 15, 2025
• Study Start: June 5, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)