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Nurse Telephone Management of Cholesterol in Diabetes (NATCHOS)

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00950963
First received: January 12, 2009
Last updated: July 31, 2009
Last verified: July 2009
History of Changes
Results First Received: January 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Type 1 Diabetes
Type 2 Diabetes
Interventions: Behavioral: Phone Counseling
Other: Standard Clinical Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment of patients began in September 2005 from one community clinic. Study nurses attempted to contact all patients in the control group at the beginning of the study only if they had not had an LDL level in the previous 12 month. An LDL level was obtained to be used as baseline.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized directly from a registry.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Phone Counseling     Standard Care  
STARTED     381 [1]   381 [1]
COMPLETED     352     357  
NOT COMPLETED     29     24  
Lost to Follow-up                 29                 24  
[1] Patients were randomized from a diabetes registry and were followed as intent to treat



  Baseline Characteristics
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Phone Counseling     Standard Care     Total  
Number of Participants  
[units: participants]
 		  381     381     762  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     252     261     513  
>=65 years     129     120     249  
Age  
[units: years]
Mean ± Standard Deviation 		  58.5  ± 12.5     58.3  ± 12.1     58.4  ± 12.3  
Gender  
[units: participants]
 		     
Female     244     218     462  
Male     137     163     300  
Region of Enrollment  
[units: participants]
 		     
United States     381     381     762  



  Outcome Measures
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1.  Primary:   Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL   [ Time Frame: 18 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of CVD Patients With LDL Less Than 70 mg/dL.   [ Time Frame: 18 months ]
  Show Outcome Measure 2

3.  Secondary:   Number of Patients With BP Less Than 130/80 mm Hg   [ Time Frame: 18 months ]
  Show Outcome Measure 3

4.  Secondary:   Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study   [ Time Frame: 18 months ]
  Show Outcome Measure 4

5.  Other Pre-specified:   Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.   [ Time Frame: 18 months ]
  Show Outcome Measure 5


  Serious Adverse Events
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No Serious Adverse Events Entered.


  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Raymond Estaico, MD
Organization: Denver Health
phone: 303-860-9900
e-mail: Ray.Estacio@cpcmed.org


Publications:


Responsible Party: Raymond Estacio, MD, Denver Health
ClinicalTrials.gov Identifier: NCT00950963     History of Changes
Other Study ID Numbers: 05-509
Study First Received: January 12, 2009
Results First Received: January 12, 2009
Last Updated: July 31, 2009
Health Authority: United States: Institutional Review Board