Improving Diabetes Outcomes With Activity, Nutrition and Medication

Metabolic control of type 2 diabetes and prevention of its complications are related to
management of blood glucose and other factors. Medication and lifestyle modifications are
integral to most self-management plans; however, adherence remains a great challenge. Many
patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for
complications. This study is to evaluate the effectiveness and costs of a tailored, telephone
intervention to promote adherence in middle-aged and older adults with type-2 diabetes who
are members of a union/employer-sponsored health benefit plan. The target population includes
English- and Spanish-speaking individuals from the health plan database.

This study has the following specific aims:

1. A tailored telephone intervention will significantly improve medication adherence
compared to a standard care intervention.

2. A tailored telephone intervention will significantly improve metabolic control measured
by HbA1c compared to a standard care intervention 2a) We will explore ways to link
behavior change for medication adherence with lifestyle modification for diet and
physical activity.

3. To conduct cost evaluations for the telephone intervention vs. standard care. The study
design is a randomized, controlled intervention trial with masking; the individual is
the unit of sampling, assignment and analysis. After eligibility is assessed and consent
is obtained by telephone, patients will be randomized to either the telephone
intervention or standard are. Study outcomes will be medication adherence as measured
from pharmacy records and metabolic control (HbA1c). A total of 556 patients with type 2
diabetes wil be randomized, which will provide 80% power to detect a statistically
significant difference in HbA1c of at least 0.3%, and over 95% power to detect a
difference in filled prescriptions. Telephone surveys will provide data on self-care
behaviors including diet and exercise, risk perceptions, and depressive symptoms. Cost
data will be collected using standardized methods. Study results will inform
implementation of practical, nurse-managed interventions to improve medication adherence
and metabolic control in diverse, middle-aged and older, type 2 diabetes patients, while
linking changes in medication adherence to lifestyle modification for diet and physical
activity.

Inclusion Criteria:

- Type 2 diabetes

- Taking oral diabetes medication

- At least 40 years old

- In a union-sponsored health plan with full medication coverage for at least a year

- Able to understand English or Spanish

- Informed consent

Exclusion Criteria:

- Currently in a diabetes education program

- Will lose health care eligibility within a year

- Unable to receive phone calls or mail