Diabetes Mellitus Type 2NCT01330121

Bridging the Gap by Transitional Care

A study testing Pharmacist Counseling in people with Diabetes Mellitus Type 2, run by Cook County Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: Pharmacist Counseling
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Apr 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: 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

Read the detailed description

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: Diabetes Mellitus Type 2
Being tested: Pharmacist Counseling
Keywords: Adherence with discharge diabetes medications, Diabeted mellitus type 2 greater than one year, Patient with provider and prescriptions filled within CCHS
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01330121
Study group	Role	What they receive
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 Receives: Other: Pharmacist Counseling
Standard therapy	No intervention	Standard therapy: Nurses distribute a education pamphlet on diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: up to 120 days

Secondary outcomes (3)

Change in A1c after 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
Measured: up to 90 days
Change in BP after 90 days
BP in mm/Hg
Measured: up to 90 days
Change in lipids after 90 days
Lipid measurements in mg/dL
Measured: up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Apr 2011

First posted6 Apr 2011 (estimated)
Study startSep 2010
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01330121
Sponsor's protocol ID: IRB #10-165
Status last verified: Jul 2023
First submitted: 5 Apr 2011
Last updated: 12 Jul 2023
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care
ClinicalTrials.gov ID: NCT01330121
Acronym / sponsor ID: IRB #10-165
Conditions: Diabetes Mellitus Type 2
Keywords: Adherence with discharge diabetes medications, Diabeted mellitus type 2 greater than one year, Patient with provider and prescriptions filled within CCHS
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Cook County HealthOther government
Study start: Sep 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 6 Apr 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pharmacist Counseling	Active comparator	Other: Pharmacist CounselingPharmacist 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	No intervention	–Standard therapy: Nurses distribute a education pamphlet on diabetes

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pharmacist CounselingPharmacist 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

Primary outcome

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

3 secondary outcomes

Change in A1c after 90 days
Time frame: up to 90 days
Change in BP after 90 days
Time frame: up to 90 days
Change in lipids after 90 days
Time frame: up to 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.

Related trials for Diabetes Mellitus Type 2

Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leon Fogelfeld, M.D. principal investigator

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

Mansi Shah, PharmD principal investigator

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

CaTanya Norwood, R.PH principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist Counseling in people with Diabetes Mellitus Type 2, run by Cook County Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01330121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.