Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

NCT01565187 | Terminated

• 1 other identifier: 12-001131
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Arm Injuries

Keywords

Hand Transplantation

Outcome Measures

Primary Outcomes (1)

• Assessment of change in Psychosocial characteristics of hand transplantation candidates

  Using validated psychometric instruments and description of psychosocial characteristics based on a standardized assessment instrument.

  one year posttransplant

Study Arms (1)

hand transplant candidates

Participants enrolled will be asked to complete behavioral questionnaires.

Behavioral: Questionnaires

Interventions

Questionnaires 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.

Also known as: Psychometric instruments

hand transplant candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years old
• Undergoing evaluation for hand transplantation

You may not qualify if:

• unable to complete surveys

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: NONE RETAINED

No biospecimens to be gathered and used for this study.

MeSH Terms

Conditions

Arm Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sheila Jowsey, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor of Psychiatry and Director of Transplant Psychiatry

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 28, 2012
• Study Start: February 1, 2012
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

US (1)