Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sheila G. Jowsey, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01565187
First received: March 14, 2012
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Arm Injuries
Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Groups/Cohorts Assigned Interventions
hand transplant candidates
Participants enrolled will be asked to complete behavioral questionnaires.
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 Names:
  • Questionnaires
  • Psychometric instruments

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Candidate who will be receiving a hand transplant at Mayo Clinic.

Criteria

Inclusion Criteria:

  • 18 years old
  • Undergoing evaluation for hand transplantation

Exclusion Criteria:

  • unable to complete surveys
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565187

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sheila Jowsey, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Sheila G. Jowsey, MD, Assistant Professor of Psychiatry and Director of Transplant Psychiatry, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01565187     History of Changes
Other Study ID Numbers: 12-001131
Study First Received: March 14, 2012
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Hand Transplantation

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 23, 2014