NCT01330121

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

April 5, 2011

Last Update Submit

July 10, 2023

Conditions

Diabetes Mellitus Type 2

Keywords

Adherence with discharge diabetes medicationsDiabeted mellitus type 2 greater than one yearPatient with provider and prescriptions filled within CCHS

Outcome Measures

Primary Outcomes (1)

  • Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management

    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

    up to 120 days

Secondary Outcomes (3)

  • Change in A1c after 90 days

    up to 90 days

  • Change in BP after 90 days

    up to 90 days

  • Change in lipids after 90 days

    up to 90 days

Study Arms (2)

Pharmacist Counseling

ACTIVE COMPARATOR

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

Other: Pharmacist Counseling

Standard therapy

NO INTERVENTION

Standard therapy: Nurses distribute a education pamphlet on diabetes

Interventions

Pharmacist CounselingOTHER

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

Pharmacist Counseling

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Leon Fogelfeld, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Mansi Shah, PharmD

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

    PRINCIPAL INVESTIGATOR

  • CaTanya Norwood, R.PH

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Division of Endocrinology

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 6, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

US(1)