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.
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.
Brief Title
Improving Diabetes Outcomes With Activity, Nutrition and Medication
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Diabetes Mellitus, Type 2
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Medication adherence
Self-care behaviors
Telephonic intervention
Diabetes
Nutrition
Exercise
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
40 Years
NCT Id
NCT00179374
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2003-068
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Improving Diabetes Medication Adherence and Outcomes
Primary Outcomes
Outcome Measure
Medication adherence
Outcome Time Frame
1 year
Outcome Measure
Metabolic control (measured by HbA1c)
Outcome Time Frame
1 year
Secondary Ids
Secondary Id
R18DK062038
Secondary Outcomes
Outcome Time Frame
1 year
Outcome Measure
Changes in self-care behaviors including diet and exercise
Outcome Time Frame
1 year
Outcome Measure
Cost evaluations
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elizabeth Walker
Investigator Email
ewalker@montefiore.org
Investigator Phone