Educating Missouri Patients About Preemptive Living Donor Transplantation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Willingness to pursue preemptive living donor transplant [ Time Frame: pre and post-class ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| Principal Investigator: | Amy D Waterman, PhD | Washington University School of Medicine |
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 June 17, 2013