DiabetesNCT01000363
Diabetes Group Visits
An observational study of Diabetes, run by Emory University at 1 site in United States.
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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -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
Show all 10Show fewer
- Current malignancy with any evidence of disease or currently undergoing chemotherapy or radiation therapy
- Cirrhosis of the liver
- AIDS
- Mayor mental health disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes Medical Group Visits Pilot Study
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.
Read the 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.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who participate in the diabetes group visits should achieve improvement in Clinical outcomes - better A1C levels, reduced blood pressure, reduced cholesterol levels
Measured: 1 year
Secondary outcomes (4)
keeping appointments and scheduling eye exams, foot checks
Measured: 1 year
goal setting, achievement of goals, problem solving; access
Measured: 1 year
attendance at educational sessions; and satisfaction among patients and health professionals
Measured: 1 year
behavioral outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, American Association of Diabetes Educators
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, EUSOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000363
- Sponsor's protocol ID
- IRB00029165
- Status last verified
- Jul 2013
- First submitted
- 22 Oct 2009
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Medical Group Visits Pilot Study
- ClinicalTrials.gov ID
- NCT01000363
- Acronym / sponsor ID
- IRB00029165
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson, American Association of Diabetes Educators
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
EUSOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014; AzTrials last refreshed its copy on 2 Nov 2026.