Clinical trial NCT01000363: Diabetes Group Visits
Official title: Diabetes Medical Group Visits Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
name: American Association of Diabetes Educators
First posted: 2009-10-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Patients who participate in the diabetes group visits should achieve improvement in Clinical outcomes - better A1C levels, reduced blood pressure, reduced cholesterol levels
timeFrame: 1 year
Secondary outcomes:
measure: keeping appointments and scheduling eye exams, foot checks
timeFrame: 1 year
measure: goal setting, achievement of goals, problem solving; access
timeFrame: 1 year
measure: attendance at educational sessions; and satisfaction among patients and health professionals
timeFrame: 1 year
measure: behavioral outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Chamblee
country: United States
facility: Grady North DeKalb Clinic
state: Georgia
Study officials:
affiliation: EUSOM
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: