Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation

NCT ID: NCT00428012

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

QOLT

Quality of Life Therapy (QOLT) 8 weekly individual counseling sessions

Group Type: EXPERIMENTAL

Quality of Life Therapy

Intervention Type: BEHAVIORAL

8 weekly individual counseling sessions

ST

Supportive Therapy (ST) 8 weekly individual counseling sessions

Group Type: ACTIVE_COMPARATOR

Supportive Therapy

Intervention Type: BEHAVIORAL

8 weekly individual counseling sessions

Standard Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Quality of Life Therapy

8 weekly individual counseling sessions

Intervention Type: BEHAVIORAL

Supportive Therapy

8 weekly individual counseling sessions

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James Rodrigue

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James R. Rodrigue, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

The Transplant Center, Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R21DK077322

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21 DK77322 (completed)

Identifier Type: -

Identifier Source: org_study_id