Quality of Life in Pediatric Transplant Patients | NCT00678002

Studies
Quality of Life in Pediatric Transplant Patients

NCT00678002

Sponsor

Medical College of Wisconsin

Status

Terminated

Last Update Posted

Nov 30, 2020Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Kidney Transplantation
Liver Transplantation
Heart Transplantation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GC173

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor enrollment

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Nov 1, 2020Actual

First Submitted Date

May 12, 2008

First Submission Date that Met QC Criteria

May 12, 2008

First Posted Date

May 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2020

Last Update Posted Date

Nov 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stacee Lerret, Advanced Practice Nurse, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Pediatric Quality of Life Inventory (PedsQL)
PedsQL Family Impact Module
PedsQL Family Information Form
Functional Status II-R
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pediatric Quality of Life Inventory		every 6 months

Secondary Outcomes

Measure	Description	Time Frame
Peds QL Family Impact Module		every 6 months
Peds QL Family Information Form		every 6 months
Functional Status II-R

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53226	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15176957	Background	Cole CR, Bucuvalas JC, Hornung RW, Krug S, Ryckman FC, Atherton H, Alonso MP, Balistreri WF, Kotagal U. Impact of liver transplantation on HRQOL in children less than 5 years old. Pediatr Transplant. 2004 Jun;8(3):222-7. doi: 10.1111/j.1399-3046.2004.00126.x.
8820075	Background	Forsyth BW, Horwitz SM, Leventhal JM, Burger J, Leaf PJ. The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability. J Pediatr Psychol. 1996 Feb;21(1):89-101. doi: 10.1093/jpepsy/21.1.89.