Skip to main content
OpenTrials
Completed

NCT Number: NCT01330121

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist Counseling

Other

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

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Change in A1c after 90 days

    Time frame: up to 90 days

    A1c measure as % 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

  2. Change in BP after 90 days

    Time frame: up to 90 days

    BP in mm/Hg

  3. Change in lipids after 90 days

    Time frame: up to 90 days

    Lipid measurements in mg/dL

Sponsors and collaborators

Lead sponsor

Cook County Health

Other Gov

Registry information

Official study title

Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2011
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.