Endstage Kidney DiseaseNCT03046732
Implementing "Explore Transplant"- A Pilot Study
A study testing Implementing "Explore Transplant" Education in people with Endstage Kidney Disease, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT has been associated with better quality of life (QOL) [1-3], reduced morbidity and mortality[4, 5], and reduced healthcare costs[6]. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endstage Kidney Disease
- What is being tested?
- Implementing "Explore Transplant" Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2016to Nov 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years, < 80 years
- Patients undergoing maintenance hemodialysis for more than 3 months
- Able to understand English at a grade 5 level
- Those willing and able to provide informed consent
Who cannot join
- Patients with severe acute illness or condition that hampers questionnaire completion
- Dementia indicated in the medical record, indicated by the managing healthcare team
- Dialysis initiation between 0-90 days prior to enrollment
- Current, active malignancy or a history of malignancy within 2 years of successful treatment
- Current active chronic infection that is an absolute contraindication to kidney transplantation
- Unwilling or unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Humber River Hospital
Toronto, Ontario, M3M 0B2
Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
Official title: Reducing Barriers in Access to Kidney Transplantation: Implementing the "Explore Transplant" Education Program to Increase Patient Knowledge and to Facilitate Informed Decision Making- A Pilot Study
Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT has been associated with better quality of life (QOL) [1-3], reduced morbidity and mortality[4, 5], and reduced healthcare costs[6]. Studies in the US have shown that patients receiving tailored transplant education were more likely to complete the transplant evaluation [9, 14, 15]. For instance, patients receiving the Explore Transplant (ET) education program designed by Dr. Waterman, were more knowledgeable about KT and more likely to complete KT evaluation than control patients. Currently, there is a lack of standardized KT education in Ontario. Traditional approaches have been insufficient in providing the necessary education and information to enable patients to make an informed decision about their care. To address this issue, the study will assess the impact of kidney transplant related education using the Explore Transplant Ontario (ETO) education program on kidney transplant-related knowledge and on readiness to consider KT, readiness to consider living donor KT, and wait list/referral rates in patients undergoing maintenance hemodialysis.
In order to comprehensively measure this impact, 5 variables will be explored.
Read more
- Readiness to consider DDKT
- Readiness to consider LDKT
- KT related knowledge in patients
- Proportion of patients waitlisted or undergoing KT workup at 6 and 12 months after administration of ETO
- Proportion of patients who have identified at least one potential living donor at 6 and 12 months after administration of ETO
The hypotheses are as follows:
- Readiness to consider DDKT will be higher in the "intervention" group compared to the "control" group at follow up.
- Readiness to consider LDKT will be higher in the "intervention" group compared to the "control" group at follow up.
- The KT related knowledge of the patients will be higher in the "intervention" group compared to the "control" group at follow up.
- The proportion of patients waitlisted or undergoing KT workup at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.
- The proportion of patients who have at least one potential living donor at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.
Read the detailed description
ESKD impairs quality of life (QOL)QoL and leads to increased morbidity and premature mortality. In addition, healthcare costs for ESKD amounted to $1.3 billion in Canada in 2000 [22]. KT has clear survival [4] and QOL [1-3], and economic benefits [6]. Studies in the US documented that tailored education improves KT knowledge and enhances access to KT and LDKT [14, 23-26]. Current education materials and teaching for KT candidates in Ontario are not based on theoretical foundations or on research evidence. This has resulted in gaps in transplant education in Ontario and has been unable to meet the needs of the patients. By building upon research data from the US we aim to implement a culturally sensitive patient education tool that will address the current needs as well as reduce barriers whereby enhancing access to KT.
This project will increase KT knowledge among health care professionals and among patients. We will establish ongoing support for the participating nephrology centers. This will also increase KT knowledge in patients and families and enhance access to KT. The ultimate goal is to improve health outcomes and QOL by reducing barriers to KT and LDKT and to help patients and families make informed treatment decisions.
The Explore Transplant Ontario (ETO) is a parallel, non-randomized, controlled pilot study exploring the impact of an educational intervention designed to increase knowledge about kidney transplantation (KT) and readiness to consider KT. For this pilot study we will utilize a convenience sample of stable patients on hemodialysis in two large dialysis units. The "intervention" will be administered at the hemodialysis unit at Humber River Hospital; the "control" group will be recruited from the hemodialysis unit at Toronto General Hospital. Currently around 500 patients are being treated with maintenance hemodialysis in both dialysis units, with an estimate that about 300 of these patients will fulfill our inclusion criteria.
The estimated study period will be 21 months. Baseline study recruitment will occur over a period of 3 months at each of the participating dialysis centers. Data management, follow-up, and analysis will take place over the subsequent 18 months.The study recruitment period has about 60 business days and as such, recruitment rate is estimated at 5-6 patients per day of screening.
The entire study will take place over 4 distinct stages
Stage 1:
Baseline data collection will be conducted at both dialysis centers
Stage 2:
A full day training will be organized to train a selected group of dialysis nurses. This group will act as a group of clinical experts and help facilitate training and use of the ETO amongst the other health care practitioners.
Stage 3:
Following the training session, ETO will be implemented at the hemodialysis unit at Humber River Hospital as the "intervention" arm and at the Toronto General Hospital as the "control" arm. It is estimated that 300 of the hemodialysis patients will fulfill the inclusion criteria, resulting in an enrollment of 150 patients in each study arm.
Stage 4:
The study duration will take approximately 21 months to accomplish. Baseline recruitment will occur over a period of 3 months at each participating dialysis centers, estimating 5-6 patients per day of screening. Data management, follow-up, and analysis will take place over the subsequent 18 months.
Statistical Analysis Plan:
Categorical variables ("early versus "late" stage of readiness, high versus low knowledge) will be compared using logistic regression models (knowledge or readiness stage as the dependent variable; exposure to ETO education is the primary explanatory variable). Continuous knowledge score will also be analyzed in linear regression models (score as the dependent variable, exposure to ET as the primary explanatory variable). These analyses will then be adjusted for age, gender, education, ethnicity/race and comorbidity.
Chi-square test will be used to compare the proportions of patients on KT waiting list and under KT evaluation in the control versus the intervention group, both at baseline and at the 3 month follow up.
Baseline data about the proportion of patients on the KT waiting list and under KT evaluation in participating dialysis centers will be collected at the participating dialysis units.
- Conditions
- Endstage Kidney Disease
- Being tested
- Implementing "Explore Transplant" Education
- Keywords
- Kidney Transplant Education, Transplant Readiness, Living Donor Kidney Transplant, Chronic Kidney Disease, End Stage Kidney Disease, Renal Replacement Therapy
- 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.
Implementing "Explore Transplant" EducationOther
The "Explore Transplant Ontario" (ETO) education program
| Study group | Role | What they receive |
|---|---|---|
| Explore Transplant Ontario | Experimental | Intervention 'Implementing "Explore Transplant" Education' Receives: Other: Implementing "Explore Transplant" Education |
| Control | No intervention | The control arm (Usual Treatment) is at the Toronto General Hospital dialysis center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in "early stages" of kidney transplant readiness
Measured: An average of 1 year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Endstage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Mucsi, University Health Network, Toronto
- Investigators
- Istvan Mucsi, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046732
- Sponsor's protocol ID
- 16-5314-AE
- Status last verified
- May 2024
- First submitted
- 3 Feb 2017
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kovacs AZ, Molnar MZ, Szeifert L, Ambrus C, Molnar-Varga M, Szentkiralyi A, Mucsi I, Novak M. Sleep disorders, depressive symptoms and health-related quality of life--a cross-sectional comparison between kidney transplant recipients and waitlisted patients on maintenance dialysis. Nephrol Dial Transplant. 2011 Mar;26(3):1058-65. doi: 10.1093/ndt/gfq476. Epub 2010 Aug 4.
PubMed 20685829Kostro JZ, Hellmann A, Kobiela J, Skora I, Lichodziejewska-Niemierko M, Debska-Slizien A, Sledzinski Z. Quality of Life After Kidney Transplantation: A Prospective Study. Transplant Proc. 2016 Jan-Feb;48(1):50-4. doi: 10.1016/j.transproceed.2015.10.058.
PubMed 26915842Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
PubMed 10580071Tennankore KK, Kim SJ, Baer HJ, Chan CT. Survival and hospitalization for intensive home hemodialysis compared with kidney transplantation. J Am Soc Nephrol. 2014 Sep;25(9):2113-20. doi: 10.1681/ASN.2013111180. Epub 2014 May 22.
PubMed 24854268Eggers P. Comparison of treatment costs between dialysis and transplantation. Semin Nephrol. 1992 May;12(3):284-9. No abstract available.
PubMed 1615249Patzer RE, Plantinga L, Krisher J, Pastan SO. Dialysis facility and network factors associated with low kidney transplantation rates among United States dialysis facilities. Am J Transplant. 2014 Jul;14(7):1562-72. doi: 10.1111/ajt.12749. Epub 2014 May 29.
PubMed 24891272Schold JD, Srinivas TR, Kayler LK, Meier-Kriesche HU. The overlapping risk profile between dialysis patients listed and not listed for renal transplantation. Am J Transplant. 2008 Jan;8(1):58-68. doi: 10.1111/j.1600-6143.2007.02020.x. Epub 2007 Nov 2.
PubMed 17979999Waterman AD, Peipert JD, Hyland SS, McCabe MS, Schenk EA, Liu J. Modifiable patient characteristics and racial disparities in evaluation completion and living donor transplant. Clin J Am Soc Nephrol. 2013 Jun;8(6):995-1002. doi: 10.2215/CJN.08880812. Epub 2013 Mar 21.
PubMed 23520044Vamos EP, Csepanyi G, Zambo M, Molnar MZ, Rethelyi J, Kovacs A, Marton A, Nemeth Z, Novak M, Mucsi I. Sociodemographic factors and patient perceptions are associated with attitudes to kidney transplantation among haemodialysis patients. Nephrol Dial Transplant. 2009 Feb;24(2):653-60. doi: 10.1093/ndt/gfn660. Epub 2008 Nov 30.
PubMed 19047018Salter ML, Orandi B, McAdams-DeMarco MA, Law A, Meoni LA, Jaar BG, Sozio SM, Kao WH, Parekh RS, Segev DL. Patient- and provider-reported information about transplantation and subsequent waitlisting. J Am Soc Nephrol. 2014 Dec;25(12):2871-7. doi: 10.1681/ASN.2013121298. Epub 2014 Aug 28.
PubMed 25168028Olbrisch ME, Benedict SM, Haller DL, Levenson JL. Psychosocial assessment of living organ donors: clinical and ethical considerations. Prog Transplant. 2001 Mar;11(1):40-9. doi: 10.1177/152692480101100107.
PubMed 11357556Kasiske BL. The evaluation of prospective renal transplant recipients and living donors. Surg Clin North Am. 1998 Feb;78(1):27-39. doi: 10.1016/s0039-6109(05)70632-0.
PubMed 9531933Rodrigue JR, Paek MJ, Egbuna O, Waterman AD, Schold JD, Pavlakis M, Mandelbrot DA. Making house calls increases living donor inquiries and evaluations for blacks on the kidney transplant waiting list. Transplantation. 2014 Nov 15;98(9):979-86. doi: 10.1097/TP.0000000000000165.
PubMed 24825528Rodrigue JR, Pavlakis M, Egbuna O, Paek M, Waterman AD, Mandelbrot DA. The "House Calls" trial: a randomized controlled trial to reduce racial disparities in live donor kidney transplantation: rationale and design. Contemp Clin Trials. 2012 Jul;33(4):811-8. doi: 10.1016/j.cct.2012.03.015. Epub 2012 Apr 3.
PubMed 22510472Weng FL, Brown DR, Peipert JD, Holland B, Waterman AD. Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates. BMC Nephrol. 2013 Nov 19;14:256. doi: 10.1186/1471-2369-14-256.
PubMed 24245948
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Barriers in Access to Kidney Transplantation: Implementing the "Explore Transplant" Education Program to Increase Patient Knowledge and to Facilitate Informed Decision Making- A Pilot Study
- ClinicalTrials.gov ID
- NCT03046732
- Acronym / sponsor ID
- 16-5314-AE
- Conditions
- Endstage Kidney Disease
- Keywords
- Kidney Transplant Education, Transplant Readiness, Living Donor Kidney Transplant, Chronic Kidney Disease, End Stage Kidney Disease, Renal Replacement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Feb 2017 (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.
Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT has been associated with better quality of life (QOL) [1-3], reduced morbidity and mortality[4, 5], and reduced healthcare costs[6]. Studies in the US have shown that patients receiving tailored transplant education were more likely to complete the transplant evaluation [9, 14, 15]. For instance, patients receiving the Explore Transplant (ET) education program designed by Dr. Waterman, were more knowledgeable about KT and more likely to complete KT evaluation than control patients. Currently, there is a lack of standardized KT education in Ontario. Traditional approaches have been insufficient in providing the necessary education and information to enable patients to make an informed decision about their care. To address this issue, the study will assess the impact of kidney transplant related education using the Explore Transplant Ontario (ETO) education program on kidney transplant-related knowledge and on readiness to consider KT, readiness to consider living donor KT, and wait list/referral rates in patients undergoing maintenance hemodialysis.
In order to comprehensively measure this impact, 5 variables will be explored.
- Readiness to consider DDKT
- Readiness to consider LDKT
- KT related knowledge in patients
- Proportion of patients waitlisted or undergoing KT workup at 6 and 12 months after administration of ETO
- Proportion of patients who have identified at least one potential living donor at 6 and 12 months after administration of ETO
The hypotheses are as follows:
- Readiness to consider DDKT will be higher in the "intervention" group compared to the "control" group at follow up.
- Readiness to consider LDKT will be higher in the "intervention" group compared to the "control" group at follow up.
- The KT related knowledge of the patients will be higher in the "intervention" group compared to the "control" group at follow up.
- The proportion of patients waitlisted or undergoing KT workup at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.
- The proportion of patients who have at least one potential living donor at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.
Detailed description
ESKD impairs quality of life (QOL)QoL and leads to increased morbidity and premature mortality. In addition, healthcare costs for ESKD amounted to $1.3 billion in Canada in 2000 [22]. KT has clear survival [4] and QOL [1-3], and economic benefits [6]. Studies in the US documented that tailored education improves KT knowledge and enhances access to KT and LDKT [14, 23-26]. Current education materials and teaching for KT candidates in Ontario are not based on theoretical foundations or on research evidence. This has resulted in gaps in transplant education in Ontario and has been unable to meet the needs of the patients. By building upon research data from the US we aim to implement a culturally sensitive patient education tool that will address the current needs as well as reduce barriers whereby enhancing access to KT.
This project will increase KT knowledge among health care professionals and among patients. We will establish ongoing support for the participating nephrology centers. This will also increase KT knowledge in patients and families and enhance access to KT. The ultimate goal is to improve health outcomes and QOL by reducing barriers to KT and LDKT and to help patients and families make informed treatment decisions.
The Explore Transplant Ontario (ETO) is a parallel, non-randomized, controlled pilot study exploring the impact of an educational intervention designed to increase knowledge about kidney transplantation (KT) and readiness to consider KT. For this pilot study we will utilize a convenience sample of stable patients on hemodialysis in two large dialysis units. The "intervention" will be administered at the hemodialysis unit at Humber River Hospital; the "control" group will be recruited from the hemodialysis unit at Toronto General Hospital. Currently around 500 patients are being treated with maintenance hemodialysis in both dialysis units, with an estimate that about 300 of these patients will fulfill our inclusion criteria.
The estimated study period will be 21 months. Baseline study recruitment will occur over a period of 3 months at each of the participating dialysis centers. Data management, follow-up, and analysis will take place over the subsequent 18 months.The study recruitment period has about 60 business days and as such, recruitment rate is estimated at 5-6 patients per day of screening.
The entire study will take place over 4 distinct stages
Stage 1:
Baseline data collection will be conducted at both dialysis centers
Stage 2:
A full day training will be organized to train a selected group of dialysis nurses. This group will act as a group of clinical experts and help facilitate training and use of the ETO amongst the other health care practitioners.
Stage 3:
Following the training session, ETO will be implemented at the hemodialysis unit at Humber River Hospital as the "intervention" arm and at the Toronto General Hospital as the "control" arm. It is estimated that 300 of the hemodialysis patients will fulfill the inclusion criteria, resulting in an enrollment of 150 patients in each study arm.
Stage 4:
The study duration will take approximately 21 months to accomplish. Baseline recruitment will occur over a period of 3 months at each participating dialysis centers, estimating 5-6 patients per day of screening. Data management, follow-up, and analysis will take place over the subsequent 18 months.
Statistical Analysis Plan:
Categorical variables ("early versus "late" stage of readiness, high versus low knowledge) will be compared using logistic regression models (knowledge or readiness stage as the dependent variable; exposure to ETO education is the primary explanatory variable). Continuous knowledge score will also be analyzed in linear regression models (score as the dependent variable, exposure to ET as the primary explanatory variable). These analyses will then be adjusted for age, gender, education, ethnicity/race and comorbidity.
Chi-square test will be used to compare the proportions of patients on KT waiting list and under KT evaluation in the control versus the intervention group, both at baseline and at the 3 month follow up.
Baseline data about the proportion of patients on the KT waiting list and under KT evaluation in participating dialysis centers will be collected at the participating dialysis units.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Explore Transplant Ontario | Experimental | Other: Implementing "Explore Transplant" EducationIntervention 'Implementing "Explore Transplant" Education' |
| Control | No intervention | –The control arm (Usual Treatment) is at the Toronto General Hospital dialysis center. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years, < 80 years
- Patients undergoing maintenance hemodialysis for more than 3 months
- Able to understand English at a grade 5 level
- Those willing and able to provide informed consent
Key exclusion criteria (6 listed)
- Patients with severe acute illness or condition that hampers questionnaire completion
- Dementia indicated in the medical record, indicated by the managing healthcare team
- Dialysis initiation between 0-90 days prior to enrollment
- Current, active malignancy or a history of malignancy within 2 years of successful treatment
- Current active chronic infection that is an absolute contraindication to kidney transplantation
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 |
|---|---|---|
| Implementing "Explore Transplant" EducationThe "Explore Transplant Ontario" (ETO) education program | Other | Explore Transplant Ontario |
Primary outcome
The proportion of patients in "early stages" of kidney transplant readiness
Time frame: An average of 1 year and a half
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 9 May 2024.
- Background: PubMed 20685829Kovacs AZ, Molnar MZ, Szeifert L, Ambrus C, Molnar-Varga M, Szentkiralyi A, Mucsi I, Novak M. Sleep disorders, depressive symptoms and health-related quality of life--a cross-sectional comparison between kidney transplant recipients and waitlisted patients on maintenance dialysis. Nephrol Dial Transplant. 2011 Mar;26(3):1058-65. doi: 10.1093/ndt/gfq476. Epub 2010 Aug 4.
- Background: PubMed 26915842Kostro JZ, Hellmann A, Kobiela J, Skora I, Lichodziejewska-Niemierko M, Debska-Slizien A, Sledzinski Z. Quality of Life After Kidney Transplantation: A Prospective Study. Transplant Proc. 2016 Jan-Feb;48(1):50-4. doi: 10.1016/j.transproceed.2015.10.058.
- Background: PubMed 10580071Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
- Background: PubMed 24854268Tennankore KK, Kim SJ, Baer HJ, Chan CT. Survival and hospitalization for intensive home hemodialysis compared with kidney transplantation. J Am Soc Nephrol. 2014 Sep;25(9):2113-20. doi: 10.1681/ASN.2013111180. Epub 2014 May 22.
- Background: PubMed 1615249Eggers P. Comparison of treatment costs between dialysis and transplantation. Semin Nephrol. 1992 May;12(3):284-9. No abstract available.
- Background: PubMed 24891272Patzer RE, Plantinga L, Krisher J, Pastan SO. Dialysis facility and network factors associated with low kidney transplantation rates among United States dialysis facilities. Am J Transplant. 2014 Jul;14(7):1562-72. doi: 10.1111/ajt.12749. Epub 2014 May 29.
- Background: PubMed 17979999Schold JD, Srinivas TR, Kayler LK, Meier-Kriesche HU. The overlapping risk profile between dialysis patients listed and not listed for renal transplantation. Am J Transplant. 2008 Jan;8(1):58-68. doi: 10.1111/j.1600-6143.2007.02020.x. Epub 2007 Nov 2.
- Background: PubMed 23520044Waterman AD, Peipert JD, Hyland SS, McCabe MS, Schenk EA, Liu J. Modifiable patient characteristics and racial disparities in evaluation completion and living donor transplant. Clin J Am Soc Nephrol. 2013 Jun;8(6):995-1002. doi: 10.2215/CJN.08880812. Epub 2013 Mar 21.
- Background: PubMed 19047018Vamos EP, Csepanyi G, Zambo M, Molnar MZ, Rethelyi J, Kovacs A, Marton A, Nemeth Z, Novak M, Mucsi I. Sociodemographic factors and patient perceptions are associated with attitudes to kidney transplantation among haemodialysis patients. Nephrol Dial Transplant. 2009 Feb;24(2):653-60. doi: 10.1093/ndt/gfn660. Epub 2008 Nov 30.
- Background: PubMed 25168028Salter ML, Orandi B, McAdams-DeMarco MA, Law A, Meoni LA, Jaar BG, Sozio SM, Kao WH, Parekh RS, Segev DL. Patient- and provider-reported information about transplantation and subsequent waitlisting. J Am Soc Nephrol. 2014 Dec;25(12):2871-7. doi: 10.1681/ASN.2013121298. Epub 2014 Aug 28.
- Background: PubMed 11357556Olbrisch ME, Benedict SM, Haller DL, Levenson JL. Psychosocial assessment of living organ donors: clinical and ethical considerations. Prog Transplant. 2001 Mar;11(1):40-9. doi: 10.1177/152692480101100107.
- Background: PubMed 9531933Kasiske BL. The evaluation of prospective renal transplant recipients and living donors. Surg Clin North Am. 1998 Feb;78(1):27-39. doi: 10.1016/s0039-6109(05)70632-0.
- Canada, S. Classificiation of population group 2009 \[cited 2015 August 5th, 2015\]Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Istvan Mucsi principal investigator
Toronto General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementing "Explore Transplant" Education in people with Endstage Kidney Disease, run by University Health Network, Toronto at 2 sites in Canada.
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 4 inclusion and 6 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The proportion of patients in "early stages" of kidney transplant readiness (time frame: An average of 1 year and a half). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046732, which also lists 31 linked publications.
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 9 May 2024.