Nurse Telephone Management of Cholesterol in Diabetes (NATCHOS)
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ClinicalTrials.gov Identifier: NCT00950963 |
Recruitment Status
:
Completed
First Posted
: August 3, 2009
Results First Posted
: August 3, 2009
Last Update Posted
: April 28, 2015
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Sponsor:
Denver Health and Hospital Authority
Collaborator:
American Diabetes Association
Information provided by:
Denver Health and Hospital Authority
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 12, 2009 | ||||||
First Posted Date ICMJE | August 3, 2009 | ||||||
Results First Submitted Date | January 12, 2009 | ||||||
Results First Posted Date | August 3, 2009 | ||||||
Last Update Posted Date | April 28, 2015 | ||||||
Study Start Date ICMJE | September 2005 | ||||||
Actual Primary Completion Date | May 2007 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL [ Time Frame: 18 months ] Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study
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Original Primary Outcome Measures ICMJE |
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL [ Time Frame: 18 months ] | ||||||
Change History | Complete list of historical versions of study NCT00950963 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE |
Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period. [ Time Frame: 18 months ] Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations
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Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Nurse Telephone Management of Cholesterol in Diabetes | ||||||
Official Title ICMJE | Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics | ||||||
Brief Summary | The current project is evaluating the effect of a nurse-administered phone care in diabetes to improve access to care and healthcare delivery. The setting is a federally qualified community health center serving over 1600 diabetic patients, 80% of whom are Latino. Using our diabetes registry, we have randomly assigned 762 patients to either participate in a telephone-based, nurse-run outreach program (N=381) or to continue with usual care(N=381). Three of our registered nurses learned algorithms addressing management of cholesterol, blood pressure, kidney disease, aspirin use, eye screening, and pneumovax and influenza vaccines. The program began recruitment in September 2005 and has finished follow up in May 2007. The program initially focused only on cholesterol management utilizing national guidelines and algorithms on patients with elevated cholesterol (LDL) levels but has expanded to include glycemic and blood pressure control. We found that Registered Nurses were able and willing to provide telephone care to diabetic patients according to moderately complex algorithms and to track patient data electronically with overall job satisfaction. Overall, the nurses have expressed enthusiasm but have also experience frustrations with maintaining contact and improving motivation in patients. The impact of this program on diabetes outcomes and its cost-effectiveness is currently being analyzed with the goal of implementing this program in our institution. | ||||||
Detailed Description | This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and 381 to participate in our nurse run program. Three registered nurses learned algorithms for diabetes care. These algorithms address management of lipids, glycemic control, blood pressure, nephropathy, aspirin use, eye screening, pneumovax and influenza vaccines, obesity, and cigarette smoking. The nurses were also trained in motivational interviewing techniques and facilitation of patient self-management. The primary goal was to improve lipid control in our diabetic population. Secondary outcomes address blood pressure control, glycemic control, renal function, and medication adherence. In addition, a cost-effective analysis is being performed. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Fischer H, Mackenzie T, McCullen K, Everhart R, Estacio RO. Design of a nurse-run, telephone-based intervention to improve lipids in diabetics. Contemp Clin Trials. 2008 Sep;29(5):809-16. doi: 10.1016/j.cct.2008.05.011. Epub 2008 Jun 11. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
762 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | June 2008 | ||||||
Actual Primary Completion Date | May 2007 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria:
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Sex/Gender |
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Ages | 17 Years and older (Child, Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00950963 | ||||||
Other Study ID Numbers ICMJE | 05-509 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Raymond Estacio, MD, Denver Health | ||||||
Study Sponsor ICMJE | Denver Health and Hospital Authority | ||||||
Collaborators ICMJE | American Diabetes Association | ||||||
Investigators ICMJE |
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PRS Account | Denver Health and Hospital Authority | ||||||
Verification Date | April 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |