Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation

NCT00428012 | Completed Phase 2 DMC

• 2 other identifiers: R21 DK77322 (completed)R21DK077322
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

quality of life, kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

QOLT

EXPERIMENTAL

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

Behavioral: Quality of Life Therapy

ST

ACTIVE COMPARATOR

Supportive Therapy (ST) 8 weekly individual counseling sessions

Behavioral: Supportive Therapy

Standard Care

NO INTERVENTION

Interventions

Quality of Life Therapy BEHAVIORAL

8 weekly individual counseling sessions

QOLT

Supportive Therapy BEHAVIORAL

8 weekly individual counseling sessions

ST

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Transplant Center, Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• James R. Rodrigue, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: April 1, 2011
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (1)