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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Condition or disease | Intervention/treatment | Phase |
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Type 1 Diabetes Type 2 Diabetes | Behavioral: Phone Counseling Other: Standard Clinical Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 762 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
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Experimental: Phone Counseling
The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
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Behavioral: Phone Counseling
Patient were contacted on a periodic basis via telephone to address there diabetes care.
Other Names:
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Active Comparator: Standard Care
Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
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Other: Standard Clinical Care
Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
Other Name: Standard Care |
- 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
- Number of CVD Patients With LDL Less Than 70 mg/dL. [ Time Frame: 18 months ]
- Number of Patients With BP Less Than 130/80 mm Hg [ Time Frame: 18 months ]Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.
- Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study [ Time Frame: 18 months ]Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.
- 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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Ages Eligible for Study: | 17 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients included in Denver Health diabetes registry.
- Type I and Type II diabetic patients
- Age >17 years old
- Actively utilizing Westside Clinic for their primary care (at least two visits in the past year)
- Speak either English or Spanish.
Exclusion Criteria:We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria:
- Pregnant or lactating women
- Patients with end-stage renal disease (creatinine > 3.0 mg/dl)
- Patients with a co-morbid illness with life expectancy less than 12 months, (e.g. terminal cancer or Child's Class C hepatic cirrhosis).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950963
United States, Colorado | |
Denver Health, Westside Clinic | |
Denver, Colorado, United States, 80204 |
Principal Investigator: | Raymond O Estacio, MD | Denver Health | |
Study Director: | Henry Fischer, MD | Denver Health |
Responsible Party: | Raymond Estacio, MD, Denver Health |
ClinicalTrials.gov Identifier: | NCT00950963 |
Other Study ID Numbers: |
05-509 |
First Posted: | August 3, 2009 Key Record Dates |
Results First Posted: | August 3, 2009 |
Last Update Posted: | April 28, 2015 |
Last Verified: | April 2015 |
Diabetes, Nurse phone intervention, lipid control |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |