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Quality of Life in Pediatric Transplant Patients

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678002
First Posted: May 15, 2008
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stacee Lerret, Medical College of Wisconsin
  Purpose
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.

Condition
Kidney Transplantation Liver Transplantation Heart Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients

Further study details as provided by Stacee Lerret, Medical College of Wisconsin:

Primary Outcome Measures:
  • Pediatric Quality of Life Inventory [ Time Frame: every 6 months ]

Secondary Outcome Measures:
  • Peds QL Family Impact Module [ Time Frame: every 6 months ]
  • Peds QL Family Information Form [ Time Frame: every 6 months ]
  • Functional Status II-R [ Time Frame: every 6 months ]
  • Child Vulnerability Scale [ Time Frame: every 6 months ]

Estimated Enrollment: 150
Study Start Date: October 2008
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
QOL###
All child subjects in this cohort will be listed for or already have received a solid organ transplant (kidney, heart, or liver).

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children's Hospital of Wisconsin in the Hepatology Clinic, Cardiology Clinic, and Kidney Clinic.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678002


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
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
  More Information

Publications:
Roy, C., & Andrews, H. A. (1991). The roy adaptation model: The definitive statement. East Norwalk, Connecticut: Prentice Hall.

Responsible Party: Stacee Lerret, Advanced Practice Nurse, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00678002     History of Changes
Other Study ID Numbers: CHW 08/157
GC173
First Submitted: May 12, 2008
First Posted: May 15, 2008
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Stacee Lerret, Medical College of Wisconsin:
solid organ transplant