Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179374
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2005-09-13
Brief Title:
Improving Diabetes Outcomes With Activity Nutrition and Medication
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Improving Diabetes Medication Adherence and Outcomes
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 unionemployer-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 03 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 03 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R18DK062038 | NIH | None | httpsreporternihgovquickSearchR18DK062038 |