NCT00907023

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

May 20, 2009

Last Update Submit

November 8, 2011

Conditions

Solid Organ Transplant

Keywords

solid organ transplanthospital discharge

Outcome Measures

Primary Outcomes (1)

  • Determine the influences of care coordination and discharge teaching on readiness for discharge in solid organ transplant recipients

    2 years

Secondary Outcomes (1)

  • 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

Study Arms (1)

SOT

Patients that have had a solid organ transplant

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Three Pediatric Transplant Hospitals

You may qualify if:

  • parents of children who have undergo a heart, kidney, or liver transplant
  • English Speaking
  • Parents are 18 years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

  • Stacee Lerret, CPNP

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, CPNP

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 22, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2011

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

US(3)