Improving Diabetes Outcomes With Activity, Nutrition and Medication

Improving Diabetes Medication Adherence and Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Tailored telephone intervention of education; Behavioral: Print educational intervention

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 Type: Interventional
• Enrollment (Actual): 556
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Elizabeth A Walker, DNSc, RN, Albert Einstein College of Medicine; Principal Investigator: Hillel W Cohen, DrPH, MPH, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Exercise; Nutrition; Medication adherence; Self-care behaviors; Telephonic intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2003-068; R18DK062038 (U.S. NIH Grant/Contract)