Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life Questionnaire

NCT ID: NCT06577480

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-26

Study Completion Date

2026-06-26

Brief Summary

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Liver transplantation is a crucial treatment for life-threatening liver diseases, including acute liver failure, end-stage chronic liver disease, primary liver cancers, and congenital metabolic disorders. Quality of life in liver transplant patients is vital. The World Health Organization defines quality of life as an individual's perception of their position in life within the context of culture, values, goals, and expectations. Liver transplantation improves quality of life. Recipients should be closely monitored and supported psychologically, with the effectiveness of the intervention in improving quality of life well-documented. Saab et al. developed the post-Liver Transplantation Quality of Life (pLTQ) questionnaire, which includes eight sub-dimensions across 32 items. To our knowledge, no Turkish-specific QoL tool for liver transplant patients currently exists. This study aims to validate and assess the reliability of the Turkish version of the pLTQ questionnaire.

Detailed Description

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Conditions

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Liver Transplant Disorder Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Liver transplant recipients

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being 18 years of age or older,
* Having received post-liver transplant treatment at Hacettepe University Adult Hospital General Surgery Units and being referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit after routine clinical and laboratory examinations, if deemed appropriate for the study,
* Being willing to participate in the study.

Exclusion Criteria

* Having undergone combined liver-kidney transplantation and multiple organ transplantation,
* Having uncontrolled cardiovascular and neurological problems,
* Having a cognitive problem that will prevent understanding the questionnaires,
* Not being willing to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Aslihan Cakmak

Aslihan Cakmak-Onal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aslihan Cakmak-Onal, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Naciye Vardar-Yagli, PhD, PT

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Mahmud N. Selection for Liver Transplantation: Indications and Evaluation. Curr Hepatol Rep. 2020;19(3):203-212. doi: 10.1007/s11901-020-00527-9. Epub 2020 Jun 19.

Reference Type BACKGROUND
PMID: 32837824 (View on PubMed)

Akarsu M. Liver transplantation in Turkey: The importance of experience. Turk J Gastroenterol. 2018 Nov;29(6):629-630. doi: 10.5152/tjg.2018.81018. No abstract available.

Reference Type BACKGROUND
PMID: 30381270 (View on PubMed)

Muller PC, Kabacam G, Vibert E, Germani G, Petrowsky H. Current status of liver transplantation in Europe. Int J Surg. 2020 Oct;82S:22-29. doi: 10.1016/j.ijsu.2020.05.062. Epub 2020 May 23.

Reference Type BACKGROUND
PMID: 32454252 (View on PubMed)

Girgenti R, Tropea A, Buttafarro MA, Ragusa R, Ammirata M. Quality of Life in Liver Transplant Recipients: A Retrospective Study. Int J Environ Res Public Health. 2020 May 27;17(11):3809. doi: 10.3390/ijerph17113809.

Reference Type BACKGROUND
PMID: 32471157 (View on PubMed)

Onghena L, Develtere W, Poppe C, Geerts A, Troisi R, Vanlander A, Berrevoet F, Rogiers X, Van Vlierberghe H, Verhelst X. Quality of life after liver transplantation: State of the art. World J Hepatol. 2016 Jun 28;8(18):749-56. doi: 10.4254/wjh.v8.i18.749.

Reference Type BACKGROUND
PMID: 27366301 (View on PubMed)

Jay CL, Butt Z, Ladner DP, Skaro AI, Abecassis MM. A review of quality of life instruments used in liver transplantation. J Hepatol. 2009 Nov;51(5):949-59. doi: 10.1016/j.jhep.2009.07.010. Epub 2009 Jul 28.

Reference Type BACKGROUND
PMID: 19775771 (View on PubMed)

Vedadi A, Khairalla R, Che A, Nagee A, Saqib M, Ayub A, Wasim A, Macanovic S, Orchanian-Cheff A, Selzner-Malekkiani N, Bartlett S, Mucsi I. Patient-reported outcomes and patient-reported outcome measures in liver transplantation: a scoping review. Qual Life Res. 2023 Sep;32(9):2435-2445. doi: 10.1007/s11136-023-03405-1. Epub 2023 Apr 6.

Reference Type BACKGROUND
PMID: 37022585 (View on PubMed)

Rimmer B, Jenkins R, Russell S, Craig D, Sharp L, Exley C. Assessing quality of life in solid organ transplant recipients: A systematic review of the development, content, and quality of available condition- and transplant-specific patient-reported outcome measures. Transplant Rev (Orlando). 2024 Apr;38(2):100836. doi: 10.1016/j.trre.2024.100836. Epub 2024 Feb 13.

Reference Type BACKGROUND
PMID: 38359538 (View on PubMed)

Saab S, Ng V, Landaverde C, Lee SJ, Comulada WS, Arevalo J, Durazo F, Han SH, Younossi Z, Busuttil RW. Development of a disease-specific questionnaire to measure health-related quality of life in liver transplant recipients. Liver Transpl. 2011 May;17(5):567-79. doi: 10.1002/lt.22267.

Reference Type BACKGROUND
PMID: 21506245 (View on PubMed)

Kim WR, Mannalithara A, Heimbach JK, Kamath PS, Asrani SK, Biggins SW, Wood NL, Gentry SE, Kwong AJ. MELD 3.0: The Model for End-Stage Liver Disease Updated for the Modern Era. Gastroenterology. 2021 Dec;161(6):1887-1895.e4. doi: 10.1053/j.gastro.2021.08.050. Epub 2021 Sep 3.

Reference Type BACKGROUND
PMID: 34481845 (View on PubMed)

Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

Reference Type BACKGROUND
PMID: 11124735 (View on PubMed)

Soyyigit S, Erk M, Guler N, Kilinc G. [The value of SF-36 questionnaire for the measurement of life quality in chronic obstructive pulmonary disease]. Tuberk Toraks. 2006;54(3):259-66. Turkish.

Reference Type BACKGROUND
PMID: 17001544 (View on PubMed)

Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

Reference Type BACKGROUND
PMID: 10826123 (View on PubMed)

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.

Reference Type BACKGROUND
PMID: 17293726 (View on PubMed)

Other Identifiers

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SBA 24/665

Identifier Type: -

Identifier Source: org_study_id

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