Improving Diabetes Outcomes With Activity, Nutrition and Medication

Study Overview
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Brief Summary
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This study has the following specific aims: A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention. 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. To conduct cost evaluations for the telephone intervention vs. standard care.

Detailed Description
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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: A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention. 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. 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.

Official Title
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Improving Diabetes Medication Adherence and Outcomes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Tailored telephone intervention of education
* Behavioral: Print educational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tailored telephone intervention plus mailed print educational materials | Behavioral: Tailored telephone intervention of education<br>* Tailored telephone intervention to promote metabolic control of diabetes<br>|
| Active Comparator: 2<br>print intervention with no telephone component | Behavioral: Print educational intervention<br>* diabetes educational materials by mail<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence |  | 1 year | 
| Metabolic control (measured by HbA1c) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-care behaviors including diet and exercise |  | 1 year | 
| Cost evaluations |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Self-care behaviors, Telephonic intervention, Diabetes, Nutrition, Exercise