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NCT Number: NCT06577480

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Anthropometric and clinical characteristics

    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.

  2. Model for End-Stage Liver Disease score index

    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).

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation of Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life (pLTQ) Questionnaire

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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