search
Back to results

Educating Missouri Patients About Preemptive Living Donor Transplantation

Primary Purpose

Chronic Kidney Disease, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transplant education with video
Transplant education with speakers
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Missouri Kidney Program
  • Washington University
  • Missouri Kidney Program
  • Missouri Kidney Program
  • Missouri Kidney Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard transplant education

Transplant education with video

Transplant education with speakers

Arm Description

Missouri Kidney Program's standard Patient Education Program (PEP) transplant module.

Explore Transplant transplant module featuring video

Explore Transplant transplant module featuring live guest speakers.

Outcomes

Primary Outcome Measures

Willingness to pursue preemptive living donor transplant

Secondary Outcome Measures

Preemptive living donor transplant rates

Full Information

First Posted
July 20, 2009
Last Updated
September 13, 2011
Sponsor
Washington University School of Medicine
Collaborators
Missouri Kidney Program, Health Resources and Services Administration (HRSA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01048437
Brief Title
Educating Missouri Patients About Preemptive Living Donor Transplantation
Official Title
Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Missouri Kidney Program, Health Resources and Services Administration (HRSA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End Stage Renal Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard transplant education
Arm Type
No Intervention
Arm Description
Missouri Kidney Program's standard Patient Education Program (PEP) transplant module.
Arm Title
Transplant education with video
Arm Type
Experimental
Arm Description
Explore Transplant transplant module featuring video
Arm Title
Transplant education with speakers
Arm Type
Experimental
Arm Description
Explore Transplant transplant module featuring live guest speakers.
Intervention Type
Behavioral
Intervention Name(s)
Transplant education with video
Intervention Description
1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors
Intervention Type
Behavioral
Intervention Name(s)
Transplant education with speakers
Intervention Description
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
Primary Outcome Measure Information:
Title
Willingness to pursue preemptive living donor transplant
Time Frame
pre and post-class
Secondary Outcome Measure Information:
Title
Preemptive living donor transplant rates
Time Frame
1-2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy D Waterman, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Missouri Kidney Program
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Kidney Program
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Missouri Kidney Program
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Missouri Kidney Program
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Educating Missouri Patients About Preemptive Living Donor Transplantation

We'll reach out to this number within 24 hrs