Type 2 Diabetes
Conditions
Keywords
Diabetes, Treatment Adherence, Self-management, Emotional Distress, Diabetes-related Distress
Brief summary
The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.
Interventions
BEHAVIORALTelephonic Diabetes Self-Management Support
OTHEREducational Print Materials
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New York City Department of Health and Mental Hygiene
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 21 years of age and older * Receiving treatment for diabetes at selected primary care practices throughout New York City * Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization) * Ability to speak and read English or Spanish (or someone in the household who will read to them) * Access to a telephone * Willing to give informed consent to participate and accept random assignment.
Exclusion criteria
* Stated intention to move out of the New York City area during the next year * Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff * Treatment provider deems that the patient is inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Change from baseline at 12 months | Obtained from electronic medical record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | Change from baseline at 12 months | Measured by self-report questionnaire |
| Diabetes-related distress | Change from baseline at 12 months | Measured by self-report questionnaire |
| Diabetes Self-Management | Change from baseline at 12 months | Measured by self-report questionnaire |
| Blood pressure | Baseline and 12 months | Obtained from electronic medical record. |
| Cholesterol | Baseline and 12 months | Obtained from electronic medical record. |
| Depressive symptoms | Change from baseline at 12 months | Measured by self-report questionnaire |
Countries
United States
Outcome results
None listed