Diabetes Mellitus Community Based Screening in Minority Populations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Ethnicity and Disease Community Empowerment Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Steward Carney Hospital
Boston Public Housing Authority
Information provided by (Responsible Party):
Ethnicity and Disease Community Empowerment Center
ClinicalTrials.gov Identifier:
NCT01591525
First received: May 2, 2012
Last updated: May 3, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ethnicity and Disease Community Empowerment Center
ClinicalTrials.gov Identifier: NCT01591525     History of Changes
Other Study ID Numbers: EADCEC-001
Study First Received: May 2, 2012
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014