NCT01000363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2013

Enrollment Period

4.1 years

First QC Date

October 22, 2009

Last Update Submit

July 7, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • keeping appointments and scheduling eye exams, foot checks

    1 year

  • goal setting, achievement of goals, problem solving; access

    1 year

  • attendance at educational sessions; and satisfaction among patients and health professionals

    1 year

  • behavioral outcomes

    1 year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady North DeKalb Clinic

Chamblee, Georgia, 30340, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Guillermo Umpierrez, MD

    EUSOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 9, 2014

Record last verified: 2013-07

Locations