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The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes (CADS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648244
First Posted: July 24, 2012
Last Update Posted: November 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alicia L. Warnock, Walter Reed National Military Medical Center
July 17, 2012
July 24, 2012
November 25, 2015
March 2012
March 2015   (Final data collection date for primary outcome measure)
Change in A1c [ Time Frame: baseline, 12, 24, 36, and 48 months ]
Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".
Change in A1c [ Time Frame: Every 3 months ]
Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".
Complete list of historical versions of study NCT01648244 on ClinicalTrials.gov Archive Site
  • Major events [ Time Frame: ongoing ]
    The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.
  • Other DM-related events [ Time Frame: ongoing ]
    Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
  • Glucose measures [ Time Frame: baseline, 12, 24, 36, 48 months ]
    Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
  • Blood pressure [ Time Frame: baseline, 12, 24, 36, and 48 months ]
    Clinically significant or statistically detectable changes in BP
  • Lipids [ Time Frame: baseline, 12, 24, 36, and 48 months ]
    Clinically significant or statistically detectable changes in lipid profile.
  • Patient satisfaction with treatment [ Time Frame: basline and 48 months ]
    Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
  • Quality of life [ Time Frame: baseline and 48 months ]
    Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.
  • Degree of Acceptance [ Time Frame: baseline and 48 months ]
    The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
  • Acceptance of uploading data [ Time Frame: baseline, 12, 24, 36, and 48 months ]
    The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.
  • Demographic variables [ Time Frame: baseline and 48 months ]
    The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.
  • Major events [ Time Frame: up to 18 months ]
    The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.
  • Other DM-related events [ Time Frame: up to 18 months ]
    Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
  • Glucose measures [ Time Frame: every 3 months ]
    Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
  • Blood pressure [ Time Frame: every 3 months ]
    Clinically significant or statistically detectable changes in BP
  • Lipds [ Time Frame: every 3 months ]
    Clinically significant or statistically detectable changes in lipid profile.
  • Patient satisfaction with treatment [ Time Frame: every 12 months ]
    Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
  • Quality of life [ Time Frame: every 12 months ]
    Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.
  • Degree of Acceptance [ Time Frame: every 12 months ]
    The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
  • Acceptance of uploading data [ Time Frame: every 12 months ]
    The degree of acceptance of uploading the glucose meterse by patients as measured by a technical assessment questionnaire.
  • Demographic variables [ Time Frame: Every 12 months ]
    The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.
Not Provided
Not Provided
 
The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes
The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers
The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type II Diabetes Mellitus
Other: Computer-Assisted Decision Support
The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.
Experimental: Computer-Assisted Decision Support
These providers will use the CADS program to treat their enrolled patients.
Intervention: Other: Computer-Assisted Decision Support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
  • Absence of orders for deployment or permanent change of station
  • Willingness to recruit up to 19 patients prior to randomization
  • Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Exclusion Criteria:

  • Specialist physicians
  • Orders for deployment or permanent change of station
  • Unwillingness to recruit up to 19 patients prior to randomization
  • No prior experience with management of type 2 diabetes in adults
  • Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01648244
353757
Yes
Not Provided
Not Provided
Alicia L. Warnock, Walter Reed National Military Medical Center
Walter Reed National Military Medical Center
Not Provided
Principal Investigator: Robert A Vigersky, M.D. Walter Reed National Military Medical Center
Walter Reed National Military Medical Center
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP