Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

Terminated

• Conditions: Arm Injuries
• Interventions: Behavioral: Questionnaires

• Registration Number: NCT01565187
• Lead Sponsor: Mayo Clinic

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 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Primary Completion: 2023-08-29
• Study Completion: 2023-08-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• 18 years old
• Undergoing evaluation for hand transplantation

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Exclusion Criteria

• unable to complete surveys

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hand transplant candidates	Questionnaires	Participants enrolled will be asked to complete behavioral questionnaires.

Primary Outcome Measures

Name	Time	Method
Assessment of change in Psychosocial characteristics of hand transplantation candidates	one year posttransplant	Using validated psychometric instruments and description of psychosocial characteristics based on a standardized assessment instrument.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States