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Diabetes Mellitus Community Based Screening in Minority Populations

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ClinicalTrials.gov Identifier: NCT01591525
Recruitment Status : Unknown
Verified May 2012 by Ethnicity and Disease Community Empowerment Center.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2012
Last Update Posted : May 4, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
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 Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Diabetes Mellitus Community Based Screening in Minority Populations
Study Start Date : June 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Eligibility Criteria

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 Posted: May 4, 2012    Key Record Dates
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