Liver Transplant DisorderNCT06577480
Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life Questionnaire
An observational study of Liver Transplant Disorder and Quality of Life, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Disorder, Quality of Life
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2024to 26 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant recipients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Investigation of Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life (pLTQ) Questionnaire
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.
- Conditions
- Liver Transplant Disorder, Quality of Life
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant recipients | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of quality of life - disease specific
The post-Liver Transplant Quality of Life questionnaire consists of 32 items that assess specific factors that may affect the lives of liver transplant recipients, including symptoms, mood, limitation of activities of daily living, energy level, and transplant-related care. The items are scored on a seven-point Likert-type scale, where 1 means "always" and 7 means "never." Each subsection score and a total score are obtained with the post-Liver Transplant Quality of Life questionnaire. Higher values indicate higher quality of life.
Measured: 1st day
Assessment of quality of life - general
In order to evaluate the validity of the Turkish post-Liver Transplant Quality of Life questionnaire, the Short Form-36 will be used. The Short Form-36 consists of eight sub-sections: physical function, social function, role restriction due to physical problems, role restriction due to emotional problems, mental health, vitality, body pain, general health, and change in health. Each sub-score is scored between 0 and 100. Higher scores indicate better quality of life.
Measured: 1st day
Assessment of health profile
In order to evaluate the validity of the Turkish post-Liver Transplant Quality of Life questionnaire, Nottingham Health Profile will be used. Nottingham Health Profile consists of 38 items. It has six sub-sections: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical mobility (8 items). There is a possible score range for each sub-section ranging from 0 to 100 points. Higher scores indicate greater limitations in quality of life.
Measured: 1st day
Psychosocial status assessment
The Hospital Anxiety and Depression Scale will be used to assess the anxiety and depression levels of patients. This scale consists of 14 items that aim to determine the risk of anxiety and depression in the patient, and to measure its level and severity change. The scale, which is asked to be answered by taking into account the last few days, has two subscales consisting of seven separate items measuring anxiety and depression. Higher scores indicate a better psychosocial status.
Measured: 1st day
Fatigue assessment
The Fatigue Severity Scale will be used to assess fatigue. This scale questions the patient's fatigue status in the last month. The scale, which consists of a total of 9 items, is scored on a 7-point Likert type. The total score is calculated by taking the average of the items. As the score increases, the patient's perception of fatigue increases.
Measured: 1st day
Secondary outcomes (2)
Anthropometric and clinical characteristics
Demographic and anthropometric data of the patients, etiology of the disease (HCV, HBV, alpha-1 antitrypsin deficiency, hepatosteatosis, HCC, HCC+HBV, cryptogenic, ethanol, autoimmune hepatitis, etc.), duration of the disease and waiting times on the transplant list, medications used, other accompanying problems, donor characteristics will be questioned and data on laboratory tests will be recorded from the patient files. Risk factors such as smoking and alcohol use history, hypertension, diabetes mellitus will be questioned.
Measured: 1st day
Model for End-Stage Liver Disease score index
Model for End-Stage Liver Disease score index will be used to determine the severity of chronic liver disease and it will be calculated with creatinine, bilirubin, international normalized ratio (INR), sodium and albumin values routinely checked in end-stage liver patients (https://medcalculators.stanford.edu/meld).
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start26 Jun 2024
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak, Hacettepe University
- Investigators
- Aslihan Cakmak-Onal, PhD, PT, Principal investigator, Hacettepe UniversityNaciye Vardar-Yagli, PhD, PT, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577480
- Sponsor's protocol ID
- SBA 24/665
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32837824Akarsu 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.
PubMed 30381270Muller 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.
PubMed 32454252Girgenti 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.
PubMed 32471157Onghena 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.
PubMed 27366301Jay 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.
PubMed 19775771Vedadi 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.
PubMed 37022585Rimmer 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.
PubMed 38359538Saab 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.
PubMed 21506245Kim 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.
PubMed 34481845Beaton 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.
PubMed 11124735Soyyigit 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.
PubMed 17001544Kucukdeveci 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.
PubMed 10826123Zigmond 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.
PubMed 6880820Armutlu 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.
PubMed 17293726
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life (pLTQ) Questionnaire
- ClinicalTrials.gov ID
- NCT06577480
- Acronym / sponsor ID
- SBA 24/665
- Conditions
- Liver Transplant Disorder, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant recipients | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant recipients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Liver transplant recipients |
Primary outcome
Assessment of quality of life - disease specific
Time frame: 1st day
The post-Liver Transplant Quality of Life questionnaire consists of 32 items that assess specific factors that may affect the lives of liver transplant recipients, including symptoms, mood, limitation of activities of daily living, energy level, and transplant-related care. The items are scored on a seven-point Likert-type scale, where 1 means "always" and 7 means "never." Each subsection score and a total score are obtained with the post-Liver Transplant Quality of Life questionnaire. Higher values indicate higher quality of life.
Assessment of quality of life - general
Time frame: 1st day
In order to evaluate the validity of the Turkish post-Liver Transplant Quality of Life questionnaire, the Short Form-36 will be used. The Short Form-36 consists of eight sub-sections: physical function, social function, role restriction due to physical problems, role restriction due to emotional problems, mental health, vitality, body pain, general health, and change in health. Each sub-score is scored between 0 and 100. Higher scores indicate better quality of life.
Assessment of health profile
Time frame: 1st day
In order to evaluate the validity of the Turkish post-Liver Transplant Quality of Life questionnaire, Nottingham Health Profile will be used. Nottingham Health Profile consists of 38 items. It has six sub-sections: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical mobility (8 items). There is a possible score range for each sub-section ranging from 0 to 100 points. Higher scores indicate greater limitations in quality of life.
Psychosocial status assessment
Time frame: 1st day
The Hospital Anxiety and Depression Scale will be used to assess the anxiety and depression levels of patients. This scale consists of 14 items that aim to determine the risk of anxiety and depression in the patient, and to measure its level and severity change. The scale, which is asked to be answered by taking into account the last few days, has two subscales consisting of seven separate items measuring anxiety and depression. Higher scores indicate a better psychosocial status.
Fatigue assessment
Time frame: 1st day
The Fatigue Severity Scale will be used to assess fatigue. This scale questions the patient's fatigue status in the last month. The scale, which consists of a total of 9 items, is scored on a 7-point Likert type. The total score is calculated by taking the average of the items. As the score increases, the patient's perception of fatigue increases.
2 secondary outcomes
Anthropometric and clinical characteristics
Time frame: 1st day
Model for End-Stage Liver Disease score index
Time frame: 1st day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Background: PubMed 32837824Mahmud 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.
- Background: PubMed 30381270Akarsu 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.
- Background: PubMed 32454252Muller 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.
- Background: PubMed 32471157Girgenti 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.
- Background: PubMed 27366301Onghena 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.
- Background: PubMed 19775771Jay 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.
- Background: PubMed 37022585Vedadi 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.
- Background: PubMed 38359538Rimmer 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.
- Background: PubMed 21506245Saab 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.
- Background: PubMed 34481845Kim 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.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 17001544Soyyigit 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslihan Cakmak-Onal, PhD, PT principal investigator
Hacettepe University
Naciye Vardar-Yagli, PhD, PT study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Disorder and Quality of Life, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of quality of life - disease specific (time frame: 1st day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06577480, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.