Organ TransplantationNCT01633424
The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)
An observational study of Organ Transplantation, run by Stanford University at 1 site in United States.
Trial summary
Given the extremely limited availability of donated organs, transplant candidates must be carefully evaluated and selected to ensure the success of the transplant and value of the organ to the recipient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplantation
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2016
- 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: 217 Stanford Hospital and Clinics patients fulfilled our criteria of being transplanted with heart, liver, kidney or lung between 6/1/2008 and 7/31/2011 and having been evaluated with SIPAT.
Who may be able to join
- Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011 and underwent the SIPAT evaluation before treatment.
Who cannot join
- Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011, who did not undergo the SIPAT evaluation before treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT): Psychometric Characteristics of a New Scale for the Prediction of Post-transplant Psychosocial and Medical Outcomes.
Given the extremely limited availability of donated organs, transplant candidates must be carefully evaluated and selected to ensure the success of the transplant and value of the organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well established, however, listing criteria for psychosocial risk factors (e.g., understanding of illness and transplant process, psychiatric history, support system, compliance, etc) is less standardized. The purpose of this research is to study the psychometric properties (e.g., predictive validity) of the new pre-transplant "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT) examination in patients who received heart, kidney, liver, or lung transplant and underwent the SIPAT evaluation before treatment. This new screening tool was designed to standardize the evaluation process of psychosocial risk factors and their severity, in order to enhance predictions of medical and psychosocial outcomes of patients post-transplant.
If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be amenable to clinical intervention could be identified. In turn, this may assist in developing a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of minimizing preventable problems, mitigating risk, and optimizing graft survival, patient function, and quality of life.
- Conditions
- Organ Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Measured: Assessed at any given time post initial transplantation (up to 15 minutes to assess)
Patient survival
Measured: Assessed at any given time post initial transplantation (up to 15 minutes to assess)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José R. Maldonado, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633424
- Sponsor's protocol ID
- CR-02
- Status last verified
- Aug 2023
- First submitted
- 29 Jun 2012
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT): Psychometric Characteristics of a New Scale for the Prediction of Post-transplant Psychosocial and Medical Outcomes.
- ClinicalTrials.gov ID
- NCT01633424
- Acronym / sponsor ID
- CR-02
- Conditions
- Organ Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Jul 2012 (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.
Given the extremely limited availability of donated organs, transplant candidates must be carefully evaluated and selected to ensure the success of the transplant and value of the organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well established, however, listing criteria for psychosocial risk factors (e.g., understanding of illness and transplant process, psychiatric history, support system, compliance, etc) is less standardized. The purpose of this research is to study the psychometric properties (e.g., predictive validity) of the new pre-transplant "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT) examination in patients who received heart, kidney, liver, or lung transplant and underwent the SIPAT evaluation before treatment. This new screening tool was designed to standardize the evaluation process of psychosocial risk factors and their severity, in order to enhance predictions of medical and psychosocial outcomes of patients post-transplant.
If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be amenable to clinical intervention could be identified. In turn, this may assist in developing a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of minimizing preventable problems, mitigating risk, and optimizing graft survival, patient function, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 217 Stanford Hospital and Clinics patients fulfilled our criteria of being transplanted with heart, liver, kidney or lung between 6/1/2008 and 7/31/2011 and having been evaluated with SIPAT.
Key inclusion criteria (1 listed)
- Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011 and underwent the SIPAT evaluation before treatment.
Key exclusion criteria (1 listed)
- Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011, who did not undergo the SIPAT evaluation before treatment.
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
Graft survival
Time frame: Assessed at any given time post initial transplantation (up to 15 minutes to assess)
Patient survival
Time frame: Assessed at any given time post initial transplantation (up to 15 minutes to assess)
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 16 Aug 2023.
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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.
José R. Maldonado, M.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Transplantation, run by Stanford University at 1 site 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 1 inclusion and 1 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Graft survival (time frame: Assessed at any given time post initial transplantation (up to 15 minutes to assess)). The study lists 2 primary outcomes in all. 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 16 Aug 2023.