Clinical trial NCT00179374: Improving Diabetes Outcomes With Activity, Nutrition and Medication
Official title: Improving Diabetes Medication Adherence and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Medication adherence
Self-care behaviors
Telephonic intervention
Diabetes
Nutrition
Exercise
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-16
Enrollment: 556
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Medication adherence
timeFrame: 1 year
measure: Metabolic control (measured by HbA1c)
timeFrame: 1 year
Secondary outcomes:
measure: Changes in self-care behaviors including diet and exercise
timeFrame: 1 year
measure: Cost evaluations
timeFrame: 1 year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Elizabeth A Walker, DNSc, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Hillel W Cohen, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: