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Diabetes Group Visits

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000363
First Posted: October 23, 2009
Last Update Posted: July 9, 2014
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:
Johnson & Johnson
American Association of Diabetes Educators
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
  Purpose

This pilot study aims to increase access to diabetes education by delivering it in a culturally-appropriate community setting and by involving different members of the diabetes care team including physicians, diabetes educators, and health promoters/community health workers.

Diabetes medical group visits will be held at the Grady North DeKalb satellite clinic the third Thursday of the month starting in October 2009. There will be two cohorts of patients- English speaking patients and Spanish speaking patients. Each group will be scheduled for 4 2-hour group visits throughout a period of 9 months. These visits will be every 8 weeks for each group. During the visit, the patient will be seen by a physician, attend a diabetes education session, re-fill their diabetes medications and receive lab orders.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetes Medical Group Visits Pilot Study

Further study details as provided by Guillermo Umpierrez, Emory University:

Primary Outcome Measures:
  • Patients who participate in the diabetes group visits should achieve improvement in Clinical outcomes - better A1C levels, reduced blood pressure, reduced cholesterol levels [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • keeping appointments and scheduling eye exams, foot checks [ Time Frame: 1 year ]
  • goal setting, achievement of goals, problem solving; access [ Time Frame: 1 year ]
  • attendance at educational sessions; and satisfaction among patients and health professionals [ Time Frame: 1 year ]
  • behavioral outcomes [ Time Frame: 1 year ]

Enrollment: 92
Study Start Date: November 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spanish speaking group
Diabetes medical group visits will be held at the Grady North DeKalb satellite clinic the third Thursday of the month starting in October 2009. There will be two cohorts of patients- English speaking patients and Spanish speaking patients. Each group will be scheduled for 4 2-hour group visits throughout a period of 9 months. These visits will be every 8 weeks for each group. During the visit, the patient will be seen by a physician, attend a diabetes education session, re-fill their diabetes medications, get orders for labs due, vaccinations and diabetes-related referrals.
English speaking group

Each group will be scheduled for 4 2-hour group visits throughout a period of 9 months. These visits will be every 8 weeks for each group. During the visit, the patient will be seen by a physician, attend a diabetes education session, re-fill their diabetes medications, get orders for labs due, vaccinations and diabetes-related referrals.

This visit will only focus on the patient's diabetes care. Each patient will continue to see their regular physician for their health care.

All of the services that will be provided at the medical group visit are standard of care and are the same that the patient will receive in a one-on-one visit. However, this format will allow the patient to been seen by the physician and receive diabetes education in one visit.


Detailed Description:
Patients who participate in the diabetes group visits should achieve improvement in Clinical outcomes - better A1C levels, reduced blood pressure, reduced cholesterol levels ; adherence to evidence-based medicine - keeping appointments and scheduling eye exams, foot-checks, and/or taking medication as prescribed; behavioral outcomes- goal setting, achievement of goals, problem solving; access - attendance at educational sessions; ability to obtain affordable medications and devices; and satisfaction among patients and health professionals.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We plan to study a total of 40 patients with a known history of type 1 or type 2 diabetes, ages 18-80. Patients included within this study will be determined by the set of inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  • Primary care at the Grady North DeKalb Health center
  • Valid Grady card
  • Age 18-80
  • HbA1c>=8.0% - 11.0%
  • Must speak English or Spanish

Exclusion Criteria:

  • -Primary care provider excludes patient from study
  • Patient is reluctant to participate in a group visit
  • Reduced life expectancy as determined by any of the following:
  • End-stage renal disease on dialysis
  • Active congestive heart failure II and IV
  • Lung disease requiring supplemental oxygen
  • Current malignancy with any evidence of disease or currently undergoing chemotherapy or radiation therapy
  • Cirrhosis of the liver
  • AIDS
  • Mayor mental health disorders
  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): NCT01000363


Locations
United States, Georgia
Grady North DeKalb Clinic
Chamblee, Georgia, United States, 30340
Sponsors and Collaborators
Emory University
Johnson & Johnson
American Association of Diabetes Educators
Investigators
Principal Investigator: Guillermo Umpierrez, MD EUSOM
  More Information

Responsible Party: Guillermo Umpierrez, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01000363     History of Changes
Other Study ID Numbers: IRB00029165
First Submitted: October 22, 2009
First Posted: October 23, 2009
Last Update Posted: July 9, 2014
Last Verified: July 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases