TransplantNCT01389804
Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
An observational study of Transplant, run by Medical College of Wisconsin at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant
- How many people
- 51 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents of pediatric solid organ transplant recipients (heart, kidney, liver or lung)
Who may be able to join
- the parent's child has undergone a heart, kidney, liver, lung or multivisceral transplant and is being discharged home from the hospital
- the parent is English speaking (tools being used have been validated for English participants only)
- the parent is 18 years of age or older
Who cannot join
- presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
- the child has already experienced the discharge to home transition after a previous transplant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Levine Children's Hospital
Charlotte, North Carolina, 28203
Children's Memorial Hospital
Chicago, Illinois, 60614
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53146
Children's Hospital and Medical Center of Nebraska
Omaha, Nebraska, 68114
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Transplant
- Keywords
- transplant, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Solid Organ Transplant | Parents of pediatric solid organ transplant recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute
- Responsible party
- Principal investigator, Stacee Lerret, Medical College of Wisconsin
- Investigators
- Stacee Lerret, PhD(c), RN, Principal investigator, Medical College of Wisconsin/Children's Hospital of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389804
- Sponsor's protocol ID
- CHW10/115,GC 1127
- Status last verified
- Apr 2012
- First submitted
- 3 Sep 2010
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
- ClinicalTrials.gov ID
- NCT01389804
- Acronym / sponsor ID
- CHW10/115,GC 1127
- Conditions
- Transplant
- Keywords
- transplant, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's National Research Institute
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Solid Organ Transplant | – | –Parents of pediatric solid organ transplant recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of pediatric solid organ transplant recipients (heart, kidney, liver or lung)
Key inclusion criteria (3 listed)
- the parent's child has undergone a heart, kidney, liver, lung or multivisceral transplant and is being discharged home from the hospital
- the parent is English speaking (tools being used have been validated for English participants only)
- the parent is 18 years of age or older
Key exclusion criteria (2 listed)
- presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
- the child has already experienced the discharge to home transition after a previous transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Post transplant outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacee Lerret, PhD(c), RN principal investigator
Medical College of Wisconsin/Children's Hospital of Wisconsin
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant, run by Medical College of Wisconsin at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012.