Quality of Life in Pediatric Transplant Patients

November 25, 2020 updated by: Stacee Lerret, Medical College of Wisconsin

Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients

The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions.

Study Overview

Status

Terminated

Conditions

Detailed Description

There are numerous studies that report on the quality of life in solid organ transplant recipients. However, very few studies target quality of life parameters for these children and their families across all solid organ transplantation. Furthermore, no literature directly addresses a comparison of perceptions and wellness, impact on family, and vulnerability in a comparative format by these distinct, but definitely related populations.

The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions. Outcomes will be measured by using five different instruments:

  1. Pediatric Quality of Life Inventory (PedsQL)
  2. PedsQL Family Impact Module
  3. PedsQL Family Information Form
  4. Functional Status II-R
  5. Child Vulnerability Scale (CVS)

Patients will be enrolled at the time of transplant listing, or after transplant. Patients and families will complete the survey once every 6 months while the patient is active on the respective transplant waiting list. After transplant, the patients and families will be asked to complete the survey once every 6 months for the first two years and annually thereafter.

This study may provide us with an improved understanding of parent and child perceptions in wellness, impact on family, and vulnerability within each transplant group. The results may also indicate trend differences between these three populations. These differences may help to provide insight into family perspectives allowing for greater anticipatory guidance and targeted interventions.

Study Type

Observational

Enrollment (Actual)

57

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

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

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

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children's Hospital of Wisconsin in the Hepatology Clinic, Cardiology Clinic, and Kidney Clinic.

Description

Inclusion Criteria:

  • between newborn and 21 years old
  • parent/child pairs of patients listed for or who have received a liver transplant, kidney transplant, or heart transplant

Exclusion Criteria:

  • unwilling or unable to participate
  • not in one of the above transplant groups
  • non-English speaking

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
QOL###
All child subjects in this cohort will be listed for or already have received a solid organ transplant (kidney, heart, or liver).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pediatric Quality of Life Inventory
Time Frame: every 6 months
every 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Peds QL Family Impact Module
Time Frame: every 6 months
every 6 months
Peds QL Family Information Form
Time Frame: every 6 months
every 6 months
Functional Status II-R
Time Frame: every 6 months
every 6 months
Child Vulnerability Scale
Time Frame: every 6 months
every 6 months

Collaborators and Investigators

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

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Stacee Lerret, CPNP, Medical College of Wisconsin
  • Principal Investigator: Gail Stendahl, CPNP, Children's Hospital and Health System Foundation, Wisconsin

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

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

October 1, 2008

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 15, 2008

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHW 08/157
  • GC173

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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