Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

Arm Injuries Clinical Trial

Official title:

Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01565187
• Other study ID #: 12-001131
• Status: Terminated
• Start date: February 2012
• Est. completion date: August 29, 2023

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old

• Undergoing evaluation for hand transplantation

Exclusion Criteria:

• unable to complete surveys

Related Conditions & MeSH terms

• Arm Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change in Psychosocial characteristics of hand transplantation candidates	Using validated psychometric instruments and description of psychosocial characteristics based on a standardized assessment instrument.	one year posttransplant