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Bridging the Gap by Transitional Care

This study has been completed.
Sponsor:
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01330121
First received: April 5, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

April 5, 2011
April 5, 2011
September 2010
April 2011   (final data collection date for primary outcome measure)
Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management [ Time Frame: up to 120 days ] [ Designated as safety issue: No ]
The primary efficacy endpoint will be the difference in rate of adherence with medications Adherence will be assessed at 30, 60, 90, and 120 days following discharge An average of the total adherence rate 120 days following discharge will be calculated as the primary outcome measure
Same as current
No Changes Posted
Changes in HbA1c, blood pressure, and lipid panel 90 days following pharmacist counseling [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
  • To evaluate changes in glycosylated hemoglobin (HbA1c), blood pressure (BP), and lipid panel 90 days following pharmacist counseling
  • To demonstrate an improvement in health literacy following pharmacist counseling on diabetes
  • To evaluate patient compliance with follow up appointments up to 90 days following pharmacist counseling
Same as current
Not Provided
Not Provided
 
Bridging the Gap by Transitional Care
Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care

The purpose of the study is to evaluate patient adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management

It is a prospective, randomized, controlled Study. Patients randomized in a 1:1 ratio to pharmacist counseling or standard of therapy prior to discharge.

Standard therapy: Nurses distribute a education pamphlet on diabetes.

Pharmacist Counseling includes but is not limited to:

  • Reviewing and explaining their medications (dosing, side effects, route)
  • Reviewing symptoms and complications of hyper and hypoglycemia
  • Defining glycemic & non-glycemic goal levels
  • Explaining the importance of compliance with medications & appointments
  • Educating on the basics of nutrition and physical activity
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Diabetes Mellitus Type 2
Other: Pharmacist Counseling

Pharmacist Counseling includes but is not limited to:

Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity

  • Active Comparator: Pharmacist Counseling

    Pharmacist Counseling includes but is not limited to:

    Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity

    Intervention: Other: Pharmacist Counseling
  • No Intervention: Standard therapy
    Standard therapy: Nurses distribute a education pamphlet on diabetes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females
  • 18 to 85 years of age
  • Historical diagnosis of type 2 diabetes mellitus greater than one year
  • HbA1c concentration ≥ 8%
  • Discharged from general medicine unit of John H. Stroger Jr, Hospital of Cook County
  • Patient with provider and prescriptions filled within CCHS

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Pregnancy
  • Major illness or debility, that prohibits the subject from participating in the study
  • History of any hemoglobinopathy that may affect determination of HbA1c
  • Non-English speaking patients
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330121
IRB #10-165
Yes
Leon Fogelfeld, M.D., John H. Stroger Hospital of Cook County, Division of Endocrinology
John H. Stroger Hospital
Not Provided
Principal Investigator: Leon Fogelfeld, M.D. John H. Stroger Hospital of Cook County, Division of Endocrinology
John H. Stroger Hospital
April 2011

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