Diabetes Group Visits

Diabetes Clinical Trial

Official title:

Diabetes Medical Group Visits Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000363
• Other study ID #: IRB00029165
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: July 7, 2014
• Start date: November 2009
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	Grady North DeKalb Clinic	Chamblee	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	American Association of Diabetes Educators, Johnson & Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients who participate in the diabetes group visits should achieve improvement in Clinical outcomes - better A1C levels, reduced blood pressure, reduced cholesterol levels		1 year	No
Secondary	keeping appointments and scheduling eye exams, foot checks		1 year	No
Secondary	goal setting, achievement of goals, problem solving; access		1 year	No
Secondary	attendance at educational sessions; and satisfaction among patients and health professionals		1 year	No
Secondary	behavioral outcomes		1 year	No