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Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01565187
First Posted: March 28, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheila G. Jowsey, Mayo Clinic
  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 Sheila G. Jowsey, Mayo Clinic:

Primary Outcome Measures:
  • 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
No biospecimens to be gathered and used for this study.

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (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 Name: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 14, 2012
First Posted: March 28, 2012
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Sheila G. Jowsey, Mayo Clinic:
Hand Transplantation

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries