Improving Diabetes Outcomes With Activity, Nutrition and Medication

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Improving Diabetes Medication Adherence and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179374
• Other study ID #: 2003-068
• Secondary ID: R18DK062038
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: April 24, 2018
• Start date: July 2003
• Est. completion date: July 2008

Study information

• Verified date: April 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Tailored telephone intervention of education
Tailored telephone intervention to promote metabolic control of diabetes
• Print educational intervention
diabetes educational materials by mail

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence		1 year
Primary	Metabolic control (measured by HbA1c)		1 year
Secondary	Changes in self-care behaviors including diet and exercise		1 year
Secondary	Cost evaluations		1 year