Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428012
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2007-01-25
Brief Title:
Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 awaiting kidney transplantation
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 transplantation The long-term goal of this research program is to better understand how QOL can be enhanced to identify the mechanisms underlying QOL changes to identify which patients benefit most from QOL intervention and to determine whether QOL benefits can extend beyond transplantation The objective of this research is to determine the effectiveness feasibility and applicability of Quality of Life Therapy QOLT in treating adults with ESRD awaiting renal transplantation In a recent small single-center clinical trial we demonstrated that QOLT can improve QOL psychological functioning and social intimacy in patients awaiting lung transplantation We now seek to examine whether this intervention can be effectively adapted and implemented with adults with ESRD who are awaiting renal transplantation The central hypothesis is that by targeting improvements in specific life domains QOLT yields significant clinical benefits in QOL psychological functioning and the patient-caregiver relationship This hypothesis is being tested by pursuing three specific aims 1 Determine the effectiveness of QOLT 2 Examine the differential effectiveness of QOLT by race White African American and 3 Assess the feasibility of a multisite R01 application Under the first aim adults with ESRD awaiting renal transplantation are being randomized to receive QOLT Supportive Therapy ST or Standard Care SC Primary outcomes are changes in QOL psychological functioning and social intimacy at 1 and 12 weeks post-treatment Under the second aim the relationship between race and intervention outcomes will be closely examined Under the third aim attrition rates reasons for attrition therapist adherence to treatment protocols and participant satisfaction ratings are being gathered to assess the need for protocol changes prior to developing a larger multisite clinical trial R01 application This study is innovative because it is among the first to evaluate a theoretically-driven psychological intervention to specifically improve QOL in the context of ESRD and renal transplantation The research is significant because it is expected to advance and expand understanding of how QOL can be improved in patients with ESRD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21DK077322 | NIH | None | httpsreporternihgovquickSearchR21DK077322 |