Status:
COMPLETED
Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
End-stage Renal Disease
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether psychological intervention is effective in improving quality of life, mood, and relationships among adults with end-stage renal disease who are awaiti...
Detailed Description
Despite known quality of life (QOL) deficits associated with end-stage renal disease (ESRD), there have been very few attempts to develop strategies to improve QOL in adults with ESRD awaiting renal t...
Eligibility Criteria
Inclusion
- Male or female patients between 21 and 70 years of age
- Diagnosis of ESRD
- Wait-listed for deceased donor renal transplantation (primary transplant only)
- White or African American race
- Signed informed consent
- Primary caregiver identified as spouse or domestic partner
- Resides within 60 minutes of transplant center
Exclusion
- Prior recipient of renal transplantation
- Prior recipient of other solid organ transplantation
- Wait-listed for combined kidney-pancreas transplantation
- Current substance abuse or dependency
- Currently hospitalized
- Current recipient of psychological intervention services
- Mental retardation
- Substantial cognitive impairment (score of 23 or less on the Mini-Mental State Examination)
- Communication difficulties (speech, hearing) so substantial that they would prevent patient from participating actively in one of the interventions (determined by transplant social worker)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00428012
Start Date
January 1 2007
End Date
April 1 2011
Last Update
January 6 2012
Active Locations (1)
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1
The Transplant Center, Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215