Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation|
- Assessment of change in Psychosocial characteristics of hand transplantation candidates [ Time Frame: one year posttransplant ] [ Designated as safety issue: No ]Using validated psychometric instruments and description of psychosocial characteristics based on a standardized assessment instrument.
Biospecimen Retention: None Retained
No biospecimens to be gathered and used for this study.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
hand transplant candidates
Participants enrolled will be asked to complete behavioral questionnaires.
Transplant Effects Questionnaire, Response Evaluation Measure, Patient Health Questionnaire, Generalized Anxiety Scale, Alcohol Use Disorders Test, Body Image Questionnaire, Quality of Life Uniscale, Scales of Psychosocial Well-Being, Sense of Coherence Scale.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565187
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Sheila Jowsey, MD||Mayo Clinic|