Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

NCT ID: NCT01565187

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2023-08-29

Brief Summary

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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

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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.

Conditions

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Arm Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hand transplant candidates

Participants enrolled will be asked to complete behavioral questionnaires.

Questionnaires

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Psychometric instruments

Eligibility Criteria

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Inclusion Criteria

* 18 years old
* Undergoing evaluation for hand transplantation

Exclusion Criteria

* unable to complete surveys
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sheila G. Jowsey

MD, Assistant Professor of Psychiatry and Director of Transplant Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheila Jowsey, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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12-001131

Identifier Type: -

Identifier Source: org_study_id

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