Solid Organ TransplantNCT00907023
Transition From Hospital to Home in Solid Organ Transplant (SOT)
An observational study of Solid Organ Transplant, run by Medical College of Wisconsin at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Solid Organ Transplant
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to May 2011
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Three Pediatric Transplant Hospitals
Who may be able to join
- parents of children who have undergo a heart, kidney, or liver transplant
- English Speaking
- Parents are 18 years of age or older
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Levine Children's Hospital
Charlotte, North Carolina
Children's Memorial Hospital
Chicago, Illinois, 60614
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: The Transition From Hospital to Home in Parents of Solid Organ Transplant Recipients
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.
Read the detailed 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.
- Conditions
- Solid Organ Transplant
- Keywords
- solid organ transplant, hospital discharge
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 |
|---|---|---|
| SOT | Patients that have had a solid organ transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the influences of care coordination and discharge teaching on readiness for discharge in solid organ transplant recipients
Measured: 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
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 posted22 May 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacee Lerret, Medical College of Wisconsin
- Investigators
- Stacee Lerret, CPNP, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907023
- Sponsor's protocol ID
- CHW 09/10
- Other IDs
- GC 811
- Status last verified
- Nov 2011
- First submitted
- 20 May 2009
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transition From Hospital to Home in Parents of Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT00907023
- Acronym / sponsor ID
- CHW 09/10
- Conditions
- Solid Organ Transplant
- Keywords
- solid organ transplant, hospital discharge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 May 2009 (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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOT | – | –Patients that have had a solid organ transplant |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Three Pediatric Transplant Hospitals
Key inclusion criteria (3 listed)
- parents of children who have undergo a heart, kidney, or liver transplant
- English Speaking
- Parents are 18 years of age or older
Key exclusion criteria (2 listed)
- 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
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 the influences of care coordination and discharge teaching on readiness for discharge in solid organ transplant recipients
Time frame: 2 years
1 secondary outcome
Determine the relationship of parent readiness for hospital discharge with coping, utilization of healthcare resources, medication adherence, and parent adjustment following hospital discharge
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 10 Nov 2011.
Related trials for Solid Organ Transplant
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Active, not recruitingPhase 2
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
Solid Organ Transplant, Viral Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
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, CPNP principal investigator
Medical College of Wisconsin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplant, run by Medical College of Wisconsin at 3 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 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 the influences of care coordination and discharge teaching on readiness for discharge in 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 10 Nov 2011.