Clinical trial NCT00895986: Using Conversation Maps to Reinforce Self-Care
Official title: Achieving and Maintaining Glycemic Control: Using Conversation Maps to Reinforce Self-Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Education
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2009-05-11
Enrollment: 134
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Improved frequency of recommended self-care behaviors (Self-Care Inventory-R)
timeFrame: 3, 6, and 12 months post intervention
Secondary outcomes:
measure: HbA1c
timeFrame: 3, 6, and 12 months post intervention
measure: Diabetes Quality of Life (scale)
timeFrame: 3, 6, and 12 months post intervention
measure: Major mediating/moderating variables include Problem Areas in Diabetes, Brief Symptom Inventory, Coping Styles, and Confidence in Diabetes
timeFrame: 3, 6, and 12 months post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Katie Weinger, EdD, RN
role: PRINCIPAL_INVESTIGATOR
References: