Clinical Trial: Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

Brief Summary: A prospective multicenter study utilizing standardized instruments for the psychological assessment of hand transplant candidates pre and post-transplant as well as those candidates excluded for transplantation.

Detailed Summary:

The semi-structured psychological interview describes the assessment of significant psychosocial characteristics and it is based on the psychosocial domains of the "Transplant Evaluation Rating Scale (TERS)" by Twillman and colleagues for evaluating organ transplant candidates. The interview guide was developed as a tool to guide clinicians through the interview process for hand transplant candidates. The protocol highlights issues that are specific for reconstructive hand transplantation and give clinicians an immediate understanding of what type of information is necessary to conduct a comprehensive psychosocial assessment.

Additionally, the psychological assessment provides standardized psychological screening procedures and continuous follow-up ratings by psychometrical testing. The test battery will be performed at the time of initial psychosocial assessment, immediately after transplant, at six and twelve months for the transplant candidates and at initial evaluation, six and twelve months for candidates excluded for transplant.


Sponsor: Mayo Clinic

Current Primary Outcome: Assessment of change in Psychosocial characteristics of hand transplantation candidates [ Time Frame: one year posttransplant ]

Using validated psychometric instruments and description of psychosocial characteristics based on a standardized assessment instrument.


Original Primary Outcome: Psychosocial characteristics of hand transplantation candidates [ Time Frame: one year posttransplant ]

Assessment of change in validated psychometric instruments and description of psychosocial characteristics based on a standardized assessment instrument.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: March 14, 2012
Date Started: February 2012
Date Completion: March 2018
Last Updated: May 10, 2016
Last Verified: May 2016