Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100, Turkey (Türkiye)
NCT Number: NCT06577480
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Ankara, 06100, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
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.
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.
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.
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.
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.
Time frame: 1st day
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.
Time frame: 1st day
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).
Hacettepe University
Other
Investigation of Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life (pLTQ) Questionnaire
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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