Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation

End-stage Renal Disease Clinical Trial

Official title:

Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428012
• Other study ID #: R21 DK77322 (completed)
• Secondary ID: R21DK077322
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 25, 2007
• Last updated: January 5, 2012
• Start date: January 2007
• Est. completion date: April 2011

Study information

• Verified date: January 2012
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• Quality of Life Therapy
8 weekly individual counseling sessions
• Supportive Therapy
8 weekly individual counseling sessions

Locations

Country	Name	City	State
United States	The Transplant Center, Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: Scores on the following measures at 12 weeks post-intervention: Quality of Life Inventory, SF-36, KDQoL, CDC Activity Limitations Module, Hopkins Symptom Checklist, POMS, and Miller Social Intimacy Scale		12 weeks	No