Improving Diabetes Outcomes With Activity, Nutrition and Medication
This study has been completed.
Sponsor:
Albert Einstein College of Medicine of Yeshiva University
Collaborator:
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00179374
First received: September 13, 2005
Last updated: April 27, 2009
Last verified: April 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- 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.
- To conduct cost evaluations for the telephone intervention vs. standard care.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: Tailored telephone intervention of education Behavioral: Print educational intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Improving Diabetes Medication Adherence and Outcomes |
Resource links provided by NLM:
Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:
Primary Outcome Measures:
- Medication adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Metabolic control (measured by HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes in self-care behaviors including diet and exercise [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Cost evaluations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 556 |
| Study Start Date: | July 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- 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.
- 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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179374
Locations
| United States, New York | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
| Principal Investigator: | Elizabeth A Walker, DNSc, RN | Albert Einstein College of Medicine of Yeshiva University |
| Principal Investigator: | Hillel W Cohen, DrPH, MPH | Albert Einstein College of Medicine of Yeshiva University |
More Information
No publications provided
| Responsible Party: | Elizabeth A. Walker, PhD, Principal Investigator, Albert Einstein College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00179374 History of Changes |
| Other Study ID Numbers: | #2003-068, 1 R18 DK062038-01A1 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 27, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
|
Medication adherence Self-care behaviors Telephonic intervention |
Diabetes Nutrition Exercise |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013