Status:

COMPLETED

Using Conversation Maps to Reinforce Self-Care

Lead Sponsor:

Joslin Diabetes Center

Collaborating Sponsors:

American Diabetes Association

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

25-75 years

Phase:

NA

Brief Summary

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 d...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2012

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT00895986

Start Date

December 1 2008

End Date

March 1 2012

Last Update

October 18 2012

Active Locations (1)

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Joslin Diabetes Center

Boston, Massachusetts, United States, 02215