The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)
|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.|
|ClinicalTrials.gov Identifier: NCT01633424|
Recruitment Status : Unknown
Verified August 2013 by Jose R Maldonado, MD, Stanford University.
Recruitment status was: Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : August 28, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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.|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2016|
- Graft and patient survival [ Time Frame: Assessed at any given time post initial transplantation. ]
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 ClinicalTrials.gov identifier (NCT number): NCT01633424
|United States, California|
|Stanford Hospitals and Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||José R. Maldonado, M.D.||Stanford University|