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Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

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ClinicalTrials.gov Identifier: NCT01565187
Recruitment Status : Unknown
Verified May 2016 by Sheila G. Jowsey, Mayo Clinic.
Recruitment status was:  Enrolling by invitation
First Posted : March 28, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Sheila G. Jowsey, 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.

Condition or disease Intervention/treatment
Arm Injuries Behavioral: Questionnaires

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation
Study Start Date : February 2012
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


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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

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

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 Posted: March 28, 2012    Key Record Dates
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