Improving Diabetes Outcomes With Activity, Nutrition and Medication

NCT ID: NCT00179374

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 556 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2008-07-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

1

Tailored telephone intervention plus mailed print educational materials

Group Type: EXPERIMENTAL

Tailored telephone intervention of education

Intervention Type: BEHAVIORAL

Tailored telephone intervention to promote metabolic control of diabetes

2

print intervention with no telephone component

Group Type: ACTIVE_COMPARATOR

Print educational intervention

Intervention Type: BEHAVIORAL

diabetes educational materials by mail

Interventions

Tailored telephone intervention of education

Tailored telephone intervention to promote metabolic control of diabetes

Intervention Type: BEHAVIORAL

Print educational intervention

diabetes educational materials by mail

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Walker

Prof., Dept of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A Walker, DNSc, RN

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Hillel W Cohen, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

R18DK062038

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2003-068

Identifier Type: -

Identifier Source: org_study_id