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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01591525
Other study ID # EADCEC-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 2, 2012
Last updated May 3, 2012
Start date June 2012
Est. completion date January 2013

Study information

Verified date May 2012
Source Ethnicity and Disease Community Empowerment Center
Contact Kelly Lamb, MA
Phone 617-947-9095
Email lambkellyann@gmail.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults 18 and older

Exclusion Criteria:

- Type I Diabetes.

- Women who are currently pregnant.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Intervention

Behavioral:
Education on risk factors for Type II Diabetes
one-on-one education provided by a nurse practitioner or physician
Education on Type II Diabetes
one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
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.

Locations

Country Name City State
United States Lower Mills Dorchester Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Ethnicity and Disease Community Empowerment Center Boston Public Housing Authority, Steward Carney Hospital

Country where clinical trial is conducted

United States, 

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