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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01389804
Other study ID # CHW10/115,GC 1127
Secondary ID
Status Completed
Phase N/A
First received September 3, 2010
Last updated April 19, 2012
Start date July 2010
Est. completion date January 2012

Study information

Verified date April 2012
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 overall long term objective of this research is to improve health care utilization and quality of life of pediatric solid organ transplant recipients and family. Understanding the process of transition to a chronic medical condition during the acute (3 weeks after transplant) and long term (3 and 6 months) will significantly guide the development of clinical interventions aimed at maximizing adherence and family psychosocial adjustment.


Description:

Parents of children that have received a heart, kidney, liver or lung transplant will be invited to participate in this protocol.

Involvement in this study entails completion of questionnaires at 4 separate time points. Parents will first complete questionnaires regarding discharge teaching, care coordination and readiness for hospital discharge on the day of discharge from the hospital. Parents will subsequently complete questionnaires at 3 weeks, 3 months and 6 months after discharge. The post discharge questionnaires assess coping, family management, adherence and utilization of healthcare resources.

Currently, no research has been conducted related to readiness for hospital discharge of a parent as the primary caregiver for a child with solid organ transplant or the sequential relationships between hospitalization care and the trajectory of post-discharge outcomes. This research will fill the gap in knowledge needed for care of solid organ transplant children and parents.

The ability to identify factors in the first year after transplant that are predictive of decreased coping and non-adherence affords an opportunity to develop nursing and health interventions that have significant implications for care decisions, as well as disease activity and health care costs.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. the parent's child has undergone a heart, kidney, liver, lung or multivisceral transplant and is being discharged home from the hospital

2. the parent is English speaking (tools being used have been validated for English participants only)

3. the parent is 18 years of age or older

Exclusion Criteria:

1. presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report

2. the child has already experienced the discharge to home transition after a previous 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
United States Children's Hospital and Medical Center of Nebraska Omaha Nebraska
United States St. Louis Children's Hospital St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Medical College of Wisconsin Children's Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine if discharge preparation has an effect on parent readiness for hospital discharge and if readiness for hospital discharge effects post-discharge outcomes following hospital discharge in parents of solid organ transplant recipients Determine if discharge preparation (discharge teaching and care coordination) for parents of solid organ transplant children has an effect on:
(1) short term discharge transition outcomes and transition to home-based care (measured at 3 weeks post-discharge) and,(2) longer term chronic care outcomes at 3 and 6 months post-discharge.
2 years No
Secondary Post transplant outcomes Determine outcomes (parent coping, adherence, family management, and utilization of healthcare services) and the relationship between these outcomes, throughout the transition to chronic care management for families of solid organ transplant recipients at 3 weeks, 3 months and 6 months post-discharge. 2 years No
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