Educating Missouri Patients About Preemptive Living Donor Transplantation

This study has been completed.
Sponsor:
Collaborators:
Missouri Kidney Program
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Amy Waterman, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01048437
First received: July 20, 2009
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

This study is a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue preemptive living donor transplant (PLDT) and PLDT rates.


Condition Intervention
Chronic Kidney Disease
End Stage Renal Disease
Behavioral: Transplant education with video
Behavioral: Transplant education with speakers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Willingness to pursue preemptive living donor transplant [ Time Frame: pre and post-class ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preemptive living donor transplant rates [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]

Enrollment: 370
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard transplant education
Missouri Kidney Program's standard Patient Education Program (PEP) transplant module.
Experimental: Transplant education with video
Explore Transplant transplant module featuring video
Behavioral: Transplant education with video
1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors
Experimental: Transplant education with speakers
Explore Transplant transplant module featuring live guest speakers.
Behavioral: Transplant education with speakers
1 hour standard transplant module is replaced with the Explore Transplant presentation and 3 live speakers: 1 deceased donor recipient, 1 living donor recipient and 1 living donor

Detailed Description:

Preemptive living donor transplant (PLDT), where renal patients get a living donor transplant before their kidneys fail, has better graft survival and lower mortality rates than living donor transplant following dialysis. However, not all renal patients and their living donors know about or consider living donation before a patient starts dialysis; To date, patients and donors presenting for PLDT are more likely to be Caucasian, of higher socioeconomic status, and more knowledgeable about transplant. To reach all patients newly diagnosed with kidney disease, the Missouri Kidney Program conducts a community Patient Education Program (PEP) outlining patients' transplant and dialysis options. Since 1994, approximately 2000 Missouri patients newly diagnosed with kidney disease and their family members have attended 2-day PEP classes. However, the current PEP transplant module does not significantly increase patients' willingness to pursue PLDT. Through a previous HRSA grant, Dr. Waterman designed the "Explore Transplant" education program based on Prochaska's Transtheoretical Model of Behavioral Change and her previous research to address key gaps in patients' living donation knowledge and to motivate patients to consider living donation. If funded, this study would conduct a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue PLDT and PLDT rates. Secondary objectives of the study are: (2) to increase rural and minority patients' access to transplant education, and (3) to describe racial, social, economic, and other influences affecting patients' PLDT willingness. The study design is a group-randomized controlled trial of 300 patients in 30 PEP classes in St. Louis, Springfield, and Kansas City, MO; patients and their family members in 15 classes will be randomized to receive the "Explore Transplant" education module, while 15 control classes will receive the traditional PEP transplant education. Across the education and control PEP classes we will compare: (1) increased willingness to pursue PLDT using baseline and follow-up attitudinal patient surveys, and (2) rates of living donation by tracking whether patients and their living donors present to any Missouri transplant center. At the conclusion of the study, we will have learned important information about how to reach and educate patients who have not yet begun dialysis and have developed a PLDT program that could be utilized in physicians' offices and by other organizations serving renal patients to increase living donation rates.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronic kidney disease
  • Attend all 6 education modules
  • 18+ years of age
  • Have given consent by signing informed consent
  • Speak and understand English
  • Can read and understand questionnaires

Exclusion Criteria:

  • Patients who do not speak and understand English (material is presented orally)
  • Patients who cannot read and understand the questionnaires
  • Patients who are 17 years of age or younger
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048437

Locations
United States, Kansas
Missouri Kidney Program
Overland Park, Kansas, United States, 66212
United States, Missouri
Missouri Kidney Program
Saint Louis, Missouri, United States, 63122
Washington University
Saint Louis, Missouri, United States, 63110
Missouri Kidney Program
Springfield, Missouri, United States, 65807
Missouri Kidney Program
Warrensburg, Missouri, United States, 64093
Sponsors and Collaborators
Washington University School of Medicine
Missouri Kidney Program
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Amy D Waterman, PhD Washington University
  More Information

No publications provided

Responsible Party: Amy Waterman, PhD, Assistant Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01048437     History of Changes
Other Study ID Numbers: 080726
Study First Received: July 20, 2009
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014