Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care

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. Identifier: NCT01389804
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : April 23, 2012
Children's Research Institute
Information provided by (Responsible Party):
Stacee Lerret, Medical College of Wisconsin

Brief 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.

Condition or disease

Detailed 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.

Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
Study Start Date : July 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Pediatric Solid Organ Transplant
Parents of pediatric solid organ transplant recipients

Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]

    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.

Secondary Outcome Measures :
  1. Post transplant outcomes [ Time Frame: 2 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parents of pediatric solid organ transplant recipients (heart, kidney, liver or lung)

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.

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 identifier (NCT number): NCT01389804

United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital and Medical Center of Nebraska
Omaha, Nebraska, United States, 68114
United States, North Carolina
Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53146
Sponsors and Collaborators
Medical College of Wisconsin
Children's Research Institute
Principal Investigator: Stacee Lerret, PhD(c), RN Medical College of Wisconsin/Children's Hospital of Wisconsin

Responsible Party: Stacee Lerret, Assistant Professor, Medical College of Wisconsin Identifier: NCT01389804     History of Changes
Other Study ID Numbers: CHW10/115,GC 1127
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes