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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00907023
Other study ID # CHW 09/10
Secondary ID GC 811
Status Completed
Phase N/A
First received May 20, 2009
Last updated November 8, 2011
Start date January 2009
Est. completion date May 2011

Study information

Verified date November 2011
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the influences of discharge teaching and care coordination on how ready a parent is to take their child home from the hospital after a solid organ (kidney, heart and liver) transplant. This study will also look into how the parent handles coping, utilization of healthcare resources, and parent adjustment 3 weeks after discharge from the hospital.


Description:

Parents of children that have received a heart, kidney or liver transplant will be asked to participate in this protocol. Involvement in this study involves completion of questionnaires prior to the child being discharged from the hospital. Three weeks after discharge, there will also be a follow-up phone call to complete more questionnaires.

Readiness for hospital discharge is a under-investigated topic in pediatric solid organ transplant patients, despite the increasing number of pediatric patients undergoing transplant surgery. Results from this study will be used to develop an intervention program to promote readiness for hospital discharge in parents of children who receive a solid organ transplant.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date May 2011
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- parents of children who have undergo a heart, kidney, or liver transplant

- English Speaking

- Parents are 18 years of age or older

Exclusion Criteria:

- parents with significant cognitive or communication impairment that would not allow them to complete the questionnaires

- parent whose child is receiving their 2nd or 3rd organ transplant

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Levine Children's Hospital Charlotte North Carolina
United States Children's Memorial Hospital Chicago Illinois
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the influences of care coordination and discharge teaching on readiness for discharge in solid organ transplant recipients 2 years No
Secondary Determine the relationship of parent readiness for hospital discharge with coping, utilization of healthcare resources, medication adherence, and parent adjustment following hospital discharge 2 years No
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Active, not recruiting NCT03360682 - Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV‐1‐Infected Solid Organ Transplant Patients Phase 4