Chronic Kidney DiseaseNCT01054066
Managing Chronic Kidney Disease in Eastern North Carolina
A study testing Chronic Kidney Disease Education in people with Chronic Kidney Disease, run by East Carolina University at 1 site in United States.
Trial summary
The purpose of this program is to educate primary care physicians in four underserved clinics in eastern North Carolina about chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Chronic Kidney Disease Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,257 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care clinics in eastern North Carolina with a high penetration of chronic kidney disease, risk factors for chronic kidney disease and poverty.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: Management of Chronic Kidney Disease in Eastern North Carolina (MARKER)
The purpose of this program is to educate primary care physicians in four underserved clinics in eastern North Carolina about chronic kidney disease.
Read the detailed description
The Division of Nephrology within the Brody School of Medicine recently form a center to focus attention on the needs of patients with kidney disease in eastern North Carolina. It is estimated that more than 40 million Americans have or at risk for CKD. The estimate for CKD in eastern North Carolina is exacerbated by poor access to health care. The mission of the East Carolina University Center for the Study and Treatment of Kidney Disease (ECCKD) is to increase education and awareness, improve treatment and outcomes through research, and better serve patients with CKD in eastern North Carolina.
- Conditions
- Chronic Kidney Disease
- Being tested
- Chronic Kidney Disease Education
- Keywords
- Chronic Kidney Disease, Cardiovascular Disease, Hypertension, Anemia
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases, Hypertension, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Kidney Disease EducationBehavioural
Also called primary care, primary care clinics, education
Instituting teaching programs to manage hypertension, diabetes, anemia, proteinuria and cardiovascular disease in patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of CKD education on the behavior of the primary care physician in underserved areas in Eastern North Carolina.
Measured: every 6 months
Secondary outcomes (1)
To assess the rate of reduction of CKD in patients in Eastern North Carolina.
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startAug 2008
- Primary completionMay 2011
- Study completionMay 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.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- The Kate B. Reynolds Charitable Trust
- Responsible party
- Principal investigator, Paul Bolin, East Carolina University
- Investigators
- Paul Bolin, MD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054066
- Sponsor's protocol ID
- 2008-317
- Status last verified
- Apr 2012
- First submitted
- 21 Jan 2010
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Chronic Kidney Disease in Eastern North Carolina (MARKER)
- ClinicalTrials.gov ID
- NCT01054066
- Acronym / sponsor ID
- 2008-317
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Cardiovascular Disease, Hypertension, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,257 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- The Kate B. Reynolds Charitable Trust
- Study start
- Aug 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 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.
The purpose of this program is to educate primary care physicians in four underserved clinics in eastern North Carolina about chronic kidney disease.
Detailed description
The Division of Nephrology within the Brody School of Medicine recently form a center to focus attention on the needs of patients with kidney disease in eastern North Carolina. It is estimated that more than 40 million Americans have or at risk for CKD. The estimate for CKD in eastern North Carolina is exacerbated by poor access to health care. The mission of the East Carolina University Center for the Study and Treatment of Kidney Disease (ECCKD) is to increase education and awareness, improve treatment and outcomes through research, and better serve patients with CKD in eastern North Carolina.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care clinics in eastern North Carolina with a high penetration of chronic kidney disease, risk factors for chronic kidney disease and poverty.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Chronic Kidney Disease EducationAlso: primary care, primary care clinics, educationInstituting teaching programs to manage hypertension, diabetes, anemia, proteinuria and cardiovascular disease in patients. | Behavioural | – |
Primary outcome
To determine the effect of CKD education on the behavior of the primary care physician in underserved areas in Eastern North Carolina.
Time frame: every 6 months
1 secondary outcome
To assess the rate of reduction of CKD in patients in Eastern North Carolina.
Time frame: every 6 months
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 12 Apr 2012.
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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.
Paul Bolin, MD principal investigator
East Carolina 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 Chronic Kidney Disease Education in people with Chronic Kidney Disease, run by East Carolina 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 1 inclusion and 0 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 12 Apr 2012. 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?
To determine the effect of CKD education on the behavior of the primary care physician in underserved areas in Eastern North Carolina. (time frame: every 6 months). 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 12 Apr 2012.