Diabetes Mellitus Community Based Screening in Minority Populations

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2012 by Ethnicity and Disease Community Empowerment Center.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01591525

First Posted: May 4, 2012

Last Update Posted: May 4, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Steward Carney Hospital

Boston Public Housing Authority

Information provided by (Responsible Party):

Ethnicity and Disease Community Empowerment Center

Purpose

The purpose of the type II diabetes (T2D) screening study is to improve diabetes care in minority communities by identifying undiagnosed and uncontrolled T2D patients, as well as help patients without a regular primary care physician (PCP) find one within their community. These goals will be achieved first through a glucose measurement. Individuals with a high glucose measurement will be confirmed with a rapid hemoglobin A1c (HgA1c) test. The HgA1c test will tell us about the patients average blood sugar over the past 3 months, which will allow us to immediately diagnose new and uncontrolled type II diabetics. All participants will fill out a survey on healthcare seeking behaviors before glucose testing. All patients who enter the study will receive education on T2D and the value of regularly visiting their PCP, and will be provided a list of PCP currently accepting new patients within a 3 mile radius. Follow-up visits at 4 and 8 months will help us determine the success this community based screening.

The investigators hypothesis is that community based screening designed with adequate education and follow-up, and performed by qualified medical professionals will improve diabetes care in minority communities as assessed through hemoglobin A1c levels over 8 months, and in the change in the number patients who visit/obtain their PCP within the study period.

Condition	Intervention
Type II Diabetes Diabetes Mellitus	Behavioral: Education on risk factors for Type II Diabetes Behavioral: Education on Type II Diabetes Behavioral: Education on regular visits to a Primary Care Provider


Study Type:	Observational
Study Design:	Observational Model: Ecologic or Community Time Perspective: Prospective
Official Title:	Diabetes Mellitus Community Based Screening in Minority Populations

Further study details as provided by Ethnicity and Disease Community Empowerment Center:


Estimated Enrollment:	100
Study Start Date:	June 2012
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Uncontrolled Diabetic Individuals who were previously diagnosed with Type II Diabetes, but have a HgA1C greater than 7.0%	Behavioral: Education on risk factors for Type II Diabetes one-on-one education provided by a nurse practitioner or physician Other Name: educational intervention Behavioral: Education on Type II Diabetes one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician. Other Name: educational intervention Behavioral: Education on regular visits to a Primary Care Provider one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius. Other Name: educational intervention
Newly diagnosed Type II Diabetic Individuals who have never been diagnosed with Type II Diabetes, but have an HgA1c greater than 7.0%	Behavioral: Education on risk factors for Type II Diabetes one-on-one education provided by a nurse practitioner or physician Other Name: educational intervention Behavioral: Education on Type II Diabetes one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician. Other Name: educational intervention Behavioral: Education on regular visits to a Primary Care Provider one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius. Other Name: educational intervention
Newly diagnosised pre-diabetics Individuals who have never been diagnosed with Type II Diabetes, but have a HgA1C of 6.0%-6.9%	Behavioral: Education on risk factors for Type II Diabetes one-on-one education provided by a nurse practitioner or physician Other Name: educational intervention Behavioral: Education on Type II Diabetes one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician. Other Name: educational intervention Behavioral: Education on regular visits to a Primary Care Provider one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius. Other Name: educational intervention
Controlled Diabetic or non-diabetic individuals with RPCG of less than 130 mg/dl.	Behavioral: Education on risk factors for Type II Diabetes one-on-one education provided by a nurse practitioner or physician Other Name: educational intervention Behavioral: Education on regular visits to a Primary Care Provider one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius. Other Name: educational intervention

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Residents in Boston Public Housing

Criteria

Inclusion Criteria:

Adults 18 and older

Exclusion Criteria:

Type I Diabetes.
Women who are currently pregnant.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591525

Contacts


Contact: Kelly Lamb, MA	617-947-9095	lambkellyann@gmail.com
Contact: Jean Bonnet, MD	6175198176	jean.bonnet.md@gmail.com

Locations


United States, Massachusetts
Lower Mills	Not yet recruiting
Dorchester, Massachusetts, United States, 02124
Contact: Kelly Lamb, MA 617-947-9095
Principal Investigator: James Morgan, MD
Sub-Investigator: Jean Bonnet, MD

Sponsors and Collaborators

Ethnicity and Disease Community Empowerment Center

Steward Carney Hospital

Boston Public Housing Authority

Investigators


Study Director:	Kelly Lamb, MA	Ethnicity and Diseasse Community Empowerment Center
Principal Investigator:	Jean Bonnet, MD	Ethnicity and Disease Community Empowerment Center
Principal Investigator:	James Morgan, MD	Steward Carney Hospital

More Information


Responsible Party:	Ethnicity and Disease Community Empowerment Center
ClinicalTrials.gov Identifier:	NCT01591525 History of Changes
Other Study ID Numbers:	EADCEC-001
First Submitted:	May 2, 2012
First Posted:	May 4, 2012
Last Update Posted:	May 4, 2012
Last Verified:	May 2012

Keywords provided by Ethnicity and Disease Community Empowerment Center:


Type II Diabetes Minorities Diabetes Mellitus Community based screening

Additional relevant MeSH terms:


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

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