Diabetes Mellitus Community Based Screening in Minority Populations
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| ClinicalTrials.gov Identifier: NCT01591525 |
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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
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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 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Uncontrolled Diabetic
Individuals who were previously diagnosed with Type II Diabetes, but have a HgA1C greater than 7.0%
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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 |
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Newly diagnosed Type II Diabetic
Individuals who have never been diagnosed with Type II Diabetes, but have an HgA1c greater than 7.0%
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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 |
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Newly diagnosised pre-diabetics
Individuals who have never been diagnosed with Type II Diabetes, but have a HgA1C of 6.0%-6.9%
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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 |
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Controlled
Diabetic or non-diabetic individuals with RPCG of less than 130 mg/dl.
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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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults 18 and older
Exclusion Criteria:
- Type I Diabetes.
- Women who are currently pregnant.
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
| Contact: Kelly Lamb, MA | 617-947-9095 | lambkellyann@gmail.com | |
| Contact: Jean Bonnet, MD | 6175198176 | jean.bonnet.md@gmail.com |
| 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 | |
| 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 |
| 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:
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Type II Diabetes Minorities Diabetes Mellitus Community based screening |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |