Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation
Condition: End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Quality of Life Therapy; Supportive Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weekly individual counseling sessions; 8 weekly individual counseling sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: quality of life, kidney transplantation