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

August 27, 2024 updated by: Aslihan Cakmak, Hacettepe University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Liver transplant recipients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver transplant recipients
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1st day
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.
1st day
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.
1st day
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.
1st day
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.
1st day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1st day
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).
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Aslihan Cakmak-Onal, PhD, PT, Hacettepe University
  • Study Director: Naciye Vardar-Yagli, PhD, PT, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Estimated)

June 26, 2026

Study Completion (Estimated)

June 26, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SBA 24/665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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