Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation
|ClinicalTrials.gov Identifier: NCT01565187|
Recruitment Status : Enrolling by invitation
First Posted : March 28, 2012
Last Update Posted : May 12, 2016
|Condition or disease||Intervention/treatment|
|Arm Injuries||Behavioral: Questionnaires|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
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.
Other Name: Psychometric instruments
- 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.
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565187
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Sheila Jowsey, MD||Mayo Clinic|