Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00428012
First received: January 25, 2007
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
End-stage Renal Disease
Behavioral: Quality of Life Therapy
Behavioral: Supportive Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2007
Study Completion Date: April 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QOLT
Quality of Life Therapy (QOLT) 8 weekly individual counseling sessions
Behavioral: Quality of Life Therapy
8 weekly individual counseling sessions
Active Comparator: ST
Supportive Therapy (ST) 8 weekly individual counseling sessions
Behavioral: Supportive Therapy
8 weekly individual counseling sessions
No Intervention: Standard Care

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428012

Locations
United States, Massachusetts
The Transplant Center, Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: James R. Rodrigue, PhD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: James Rodrigue, Associate Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00428012     History of Changes
Other Study ID Numbers: R21 DK77322 (completed), R21DK077322
Study First Received: January 25, 2007
Last Updated: January 5, 2012
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
quality of life, kidney transplantation

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014