Clinical Trials Directory

Trials / Terminated

TerminatedNCT01565187

Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

Status
Terminated
Phase
Study type
Observational
Enrollment
3 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALQuestionnairesTransplant 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.

Timeline

Start date
2012-02-01
Primary completion
2023-08-29
Completion
2023-08-29
First posted
2012-03-28
Last updated
2024-04-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01565187. Inclusion in this directory is not an endorsement.