Cardiac Implantable Electronic Devices, Quality of Life
Conditions
Keywords
quality of life, patient reported outcomes, cardiac implantable electronic devices
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.
Interventions
validity and reliability study
Sponsors
Erol Olcok Corum Training and Research Hospital
Hacettepe University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of quality of life | 1 year | 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. |
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed