Chronic Kidney DiseaseNCT01048437
Educating Missouri Patients About Preemptive Living Donor Transplantation
A study testing Transplant education with video and Transplant education with speakers in people with Chronic Kidney Disease and End Stage Renal Disease, run by Washington University School of Medicine at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease
- What is being tested?
- Transplant education with video and Transplant education with speakers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Missouri Kidney Program
Overland Park, Kansas, 66212
Missouri Kidney Program
Springfield, Missouri, 65807
Washington University
St Louis, Missouri, 63110
Missouri Kidney Program
St Louis, Missouri, 63122
Missouri Kidney Program
Warrensburg, Missouri, 64093
About this study
Official title: Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Being tested
- Transplant education with video, Transplant education with speakers
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant education with videoBehavioural
1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors
Transplant education with speakersBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard transplant education | No intervention | Missouri Kidney Program's standard Patient Education Program (PEP) transplant module. |
| Transplant education with video | Experimental | Explore Transplant transplant module featuring video Receives: Behavioral: Transplant education with video |
| Transplant education with speakers | Experimental | Explore Transplant transplant module featuring live guest speakers. Receives: Behavioral: Transplant education with speakers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to pursue preemptive living donor transplant
Measured: pre and post-class
Secondary outcomes (1)
Preemptive living donor transplant rates
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Missouri Kidney Program, Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Amy Waterman, PhD, Washington University School of Medicine
- Investigators
- Amy D Waterman, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048437
- Sponsor's protocol ID
- 080726
- Status last verified
- Sep 2011
- First submitted
- 20 Jul 2009
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01048437
- Acronym / sponsor ID
- 080726
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Missouri Kidney Program, Health Resources and Services Administration (HRSA)
- Study start
- Sep 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard transplant education | No intervention | –Missouri Kidney Program's standard Patient Education Program (PEP) transplant module. |
| Transplant education with video | Experimental | Behavioral: Transplant education with videoExplore Transplant transplant module featuring video |
| Transplant education with speakers | Experimental | Behavioral: Transplant education with speakersExplore Transplant transplant module featuring live guest speakers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic kidney disease
- Attend all 6 education modules
- 18+ years of age
- Have given consent by signing informed consent
- Speak and understand English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplant education with video1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors | Behavioural | Transplant education with video |
| Transplant education with speakers1 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 | Behavioural | Transplant education with speakers |
Primary outcome
Willingness to pursue preemptive living donor transplant
Time frame: pre and post-class
1 secondary outcome
Preemptive living donor transplant rates
Time frame: 1-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy D Waterman, PhD principal investigator
Washington University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplant education with video and Transplant education with speakers in people with Chronic Kidney Disease and End Stage Renal Disease, run by Washington University School of Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to pursue preemptive living donor transplant (time frame: pre and post-class). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2011.