Improving Diabetes Outcomes With Activity, Nutrition and Medication

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Print educational intervention; Behavioral: Tailored telephone intervention of education

• Registration Number: NCT00179374
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

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

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Exclusion Criteria

• Currently in a diabetes education program
• Will lose health care eligibility within a year
• Unable to receive phone calls or mail

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Print educational intervention	print intervention with no telephone component
1	Tailored telephone intervention of education	Tailored telephone intervention plus mailed print educational materials

Primary Outcome Measures

Name	Time	Method
Medication adherence	1 year
Metabolic control (measured by HbA1c)	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in self-care behaviors including diet and exercise	1 year
Cost evaluations	1 year

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States