Achieving and Maintaining Glycemic Control: Using Conversation Maps to Reinforce Self-Care
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| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02215 |
| Conditions: |
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Type 2 Diabetes |
| Purpose: |
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Many people with type 2 diabetes are not able to keep their blood glucose in good control.
Improving blood glucose control and maintaining that improvement is important for diabetes
patients because doing so delays the onset and progression of severe complications of
diabetes. Although educational programs may be helpful, their effect is not always
long-lasting. This project is studying whether the Conversation Maps program (an
interactive diabetes education program) reinforces diabetes education and information and
thus helps type 2 diabetes patients take better care of their diabetes and blood glucose
levels. Half of the patients will attend the Conversation Maps program and half of the
patients will attend an educational program about blood pressure and cholesterol. Also, all
patients will come in for 4 or 5 appointments to complete surveys and other tests and have
their blood drawn. The group of patients who attend the Conversation Maps program will be
compared to the group of patients who attend the blood pressure and cholesterol program to
see if the educational programs helped diabetes patients to improve their diabetes control
and quality of life and to maintain that improvement over time.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Ages 25-75 years
- Diagnosis of type 2 diabetes mellitus
- Two A1c levels ≥7.0 % (above ADA target)
- 2 years since initial diagnosis. This will provide a minimum of two-years experience
with diabetes treatment. Also, excluding those who are newly diagnosed will prevent
improvement due to newly prescribed medications from confounding study results.
- Attended one of Joslin's group education programs or comparable 3-hour (or more)
educational programs and/or appointments
Exclusion Criteria:
- Severe complications of diabetes including renal disease (microalbumin >300 ug/mg),
severe peripheral diabetic neuropathy and/or severe peripheral vascular disease,
symptomatic severe autonomic neuropathy, that may place participants at risk when
increasing activity levels.
- Proliferative diabetic retinopathy based on dilated eye examination within one year
of study entry. Patients whose eye disease is successfully treated will be included.
- Current or planned pregnancy
- A1c levels less than 7.0% (normal range 4.0 - 6.0%) and A1c levels greater than 14%.
- A history of severe, unstable myocardial infarction, congestive heart failure or
other severe cardiac disease, or severe hypertension (systolic ≥160 mmHg or diastolic
≥ 90 mmHg) (increased risk when mildly increasing physical activity).
- A diagnosis of bipolar disorder, schizophrenia, mental retardation, organic mental
disorder, and alcohol or drug abuse will be excluded, as well as patients currently
undergoing psychiatric treatment. These exclusions are being made to avoid confounds
due to concurrent changes in mental status and the effects of ongoing psychiatric
treatment.
- Used Conversation Maps as an educational tool
- Started a new diabetes medication (pills or insulin) in past three months
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| NCT ID: |
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NCT00895986 |
| Primary Contact: |
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Principal Investigator
Katie Weinger, EdD, RN
Joslin Diabetes Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02215
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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