Bridging the Gap by Transitional Care

NCT ID: NCT01330121

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-04-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Pharmacist Counseling

Intervention Type 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

Standard therapy

Standard therapy: Nurses distribute a education pamphlet on diabetes

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook County Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Leon Fogelfeld MD

Chair, Division of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leon Fogelfeld, M.D.

Role: PRINCIPAL_INVESTIGATOR

John H. Stroger Hospital of Cook County, Division of Endocrinology

Mansi Shah, PharmD

Role: PRINCIPAL_INVESTIGATOR

John H. Stroger Hospital of Cook County, Department of Pharmacy

CaTanya Norwood, R.PH

Role: PRINCIPAL_INVESTIGATOR

John H. Stroger Hospital of Cook County, Department of Pharmacy

Locations

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John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #10-165

Identifier Type: -

Identifier Source: org_study_id

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