Kidney DiseaseRaDIANTNCT02092727
The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
A study testing Behavioral Interventions for Dialysis Facilities in people with Kidney Disease, run by Emory University at 1 site in United States.
Trial summary
The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease
- What is being tested?
- Behavioral Interventions for Dialysis Facilities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2018
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dialysis facilities within GA were considered for this intervention due to data restrictions. The remaining facilities were selected in a step-wise selection process 1) The presence of a racial disparity in referral or 2) a crude referral risk less than six percent.
- The presence of a racial disparity was based on the crude referral risk difference and the standardized referral risk difference.
- The remaining facilities had a calculated 6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean were selected for inclusion.
- The final pool of 134 facilities were randomized to either the intervention or control group using a one to one ratio.
Who cannot join
- Facilities with a 6-month population (from June-December 2012) of less than 13 End Stage Renal Disease patients <70 years of age within a facility were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dialysis Facilities throughout the State of Georgia, ESRD Network 6
Atlanta, Georgia, 30322
About this study
The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of kidney transplantation is the lowest in the nation. Further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the Southeast, where African Americans are less likely to access each step in the transplant process. The long-term goal of the investigators Coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for African American patients with kidney disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. The long-term impact of this application will be to reduce racial disparities in the kidney disease community.
- Conditions
- Kidney Disease
- Being tested
- Behavioral Interventions for Dialysis Facilities
- Keywords
- Dialysis facilities, African Americans, Racial disparity, Kidney Transplantation, Community-based Participatory Research, Coalition, Georgia
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Interventions for Dialysis FacilitiesBehavioural
- Educational seminars and monthly educational webinars
- Peer-to-peer mentoring program
- Bulletin boards about transplantation
- Facility-specific feedback reports detailing transplant referral data for their center compared to state average
- Formulate a facility-specific improvement plan to increase transplant referrals.
- Requirement to form a Patient and Family Advisory Group to increase outreach about transplant education within the facility.
- Monthly monitoring and reporting of patient referrals to ESRD Network
- Conduct a patient and family education session about transplantation
- Host a movie day to show Living ACTS (About Choices in Transplantation \& Sharing) video
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care arm will receive no specific interventions, but will have access to standard educational materials and quality improvement through End Stage Renal Disease Network 6. |
| Behavioral Intervention | Experimental | A variety of dialysis facility-level, behavioral interventions will be examined. Receives: Behavioral: Behavioral Interventions for Dialysis Facilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral for Kidney Transplantation
Following a multicomponent intervention at the dialysis facility level, change in referral for kidney transplantation from baseline to follow-up (at one year) will be calculated.
Measured: One Year
Secondary outcomes (1)
Reduction in Racial Disparity
Following a multicomponent intervention at the dialysis facility level, reduction in racial disparity (African American vs. Caucasian) of referral for transplantation (from baseline to one year follow up) will be calculated.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Rachel Patzer, PhD, Emory University
- Investigators
- Rachel E Patzer, PhD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092727
- Sponsor's protocol ID
- IRB00056381
- Other IDs
- 1R24MD008077-01
- Acronym
- RaDIANT
- Status last verified
- Feb 2018
- First submitted
- 13 Mar 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamoda RE, Gander JC, McPherson LJ, Arriola KJ, Cobb L, Pastan SO, Plantinga L, Browne T, Hartmann E, Mulloy L, Zayas C, Krisher J, Patzer RE. Process evaluation of the RaDIANT community study: a dialysis facility-level intervention to increase referral for kidney transplantation. BMC Nephrol. 2018 Jan 15;19(1):13. doi: 10.1186/s12882-017-0807-z.
PubMed 29334900Patzer RE, Gander J, Sauls L, Amamoo MA, Krisher J, Mulloy LL, Gibney E, Browne T, Plantinga L, Pastan SO; Southeastern Kidney Transplant Coalition. The RaDIANT community study protocol: community-based participatory research for reducing disparities in access to kidney transplantation. BMC Nephrol. 2014 Oct 28;15:171. doi: 10.1186/1471-2369-15-171.
PubMed 25348614
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
- ClinicalTrials.gov ID
- NCT02092727
- Acronym / sponsor ID
- RaDIANT / IRB00056381
- Conditions
- Kidney Disease
- Keywords
- Dialysis facilities, African Americans, Racial disparity, Kidney Transplantation, Community-based Participatory Research, Coalition, Georgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 20 Mar 2014 (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.
The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of kidney transplantation is the lowest in the nation. Further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the Southeast, where African Americans are less likely to access each step in the transplant process. The long-term goal of the investigators Coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for African American patients with kidney disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. The long-term impact of this application will be to reduce racial disparities in the kidney disease community.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care arm will receive no specific interventions, but will have access to standard educational materials and quality improvement through End Stage Renal Disease Network 6. |
| Behavioral Intervention | Experimental | Behavioral: Behavioral Interventions for Dialysis FacilitiesA variety of dialysis facility-level, behavioral interventions will be examined. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dialysis facilities within GA were considered for this intervention due to data restrictions. The remaining facilities were selected in a step-wise selection process 1) The presence of a racial disparity in referral or 2) a crude referral risk less than six percent.
- The presence of a racial disparity was based on the crude referral risk difference and the standardized referral risk difference.
- The remaining facilities had a calculated 6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean were selected for inclusion.
- The final pool of 134 facilities were randomized to either the intervention or control group using a one to one ratio.
Key exclusion criteria (1 listed)
- Facilities with a 6-month population (from June-December 2012) of less than 13 End Stage Renal Disease patients <70 years of age within a facility were excluded.
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 |
|---|---|---|
| Behavioral Interventions for Dialysis Facilities1. Educational seminars and monthly educational webinars 2. Peer-to-peer mentoring program 3. Bulletin boards about transplantation 4. Facility-specific feedback reports detailing transplant referral data for their center compared to state average 5. Formulate a facility-specific improvement plan to increase transplant referrals. 6. Requirement to form a Patient and Family Advisory Group to increase outreach about transplant education within the facility. 7. Monthly monitoring and reporting of patient referrals to ESRD Network 8. Conduct a patient and family education session about transplantation 9. Host a movie day to show Living ACTS (About Choices in Transplantation \& Sharing) video | Behavioural | Behavioral Intervention |
Primary outcome
Referral for Kidney Transplantation
Time frame: One Year
Following a multicomponent intervention at the dialysis facility level, change in referral for kidney transplantation from baseline to follow-up (at one year) will be calculated.
1 secondary outcome
Reduction in Racial Disparity
Time frame: One Year
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 22 Feb 2018.
- Derived from this study: PubMed 29334900Hamoda RE, Gander JC, McPherson LJ, Arriola KJ, Cobb L, Pastan SO, Plantinga L, Browne T, Hartmann E, Mulloy L, Zayas C, Krisher J, Patzer RE. Process evaluation of the RaDIANT community study: a dialysis facility-level intervention to increase referral for kidney transplantation. BMC Nephrol. 2018 Jan 15;19(1):13. doi: 10.1186/s12882-017-0807-z.
- Derived from this study: PubMed 25348614Patzer RE, Gander J, Sauls L, Amamoo MA, Krisher J, Mulloy LL, Gibney E, Browne T, Plantinga L, Pastan SO; Southeastern Kidney Transplant Coalition. The RaDIANT community study protocol: community-based participatory research for reducing disparities in access to kidney transplantation. BMC Nephrol. 2014 Oct 28;15:171. doi: 10.1186/1471-2369-15-171.
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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.
Rachel E Patzer, PhD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Interventions for Dialysis Facilities in people with Kidney Disease, run by Emory University at 1 site 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 4 inclusion and 1 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Referral for Kidney Transplantation (time frame: One Year). 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 NCT02092727, which also lists 2 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 22 Feb 2018.