Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263835
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2005-12-07
Brief Title:
A Self-care Intervention for Latino Adults With Diabetes
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
A Self-care Intervention for Latino Adults With Diabetes
Status:
COMPLETED
Status Verified Date:
2010-03
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:
The purpose of this study is to modify and evaluate a culturally appropriate intervention that is designed to improve diabetes self-care practices by enhancing the self-efficacy empowerment and diabetes knowledge among Latino adults over the age of 55 years
Detailed Description:
It is recognized that Latinos with diabetes experience substantially worse process and outcomes of care To address this problem the goal of the proposed study is to modify and evaluate a culturally appropriate intervention designed to improve diabetes self-care practices by enhancing the self-efficacy empowerment and diabetes-specific knowledge among Latino adults over the age of 55 years Specific aims of the project are 1 to modify an existing empowerment intervention to improve self-care skills among Latinos with diabetes 2 to test the effect of a patient-centered culturally-tailored intervention that focuses on increasing self-efficacy knowledge about diabetes care and self-care skills among Latinos with diabetes on a biophysiological endpoints such as glycemic control b self-efficacy diabetes-specific knowledge and self-care behaviors c psychosocial endpoints such as quality of life and d total costs and cost-effectiveness of care and 3 to test the effect of the intervention on compliance with indicators of good process of diabetes care To evaluate the effectiveness of the intervention the research team will conduct a controlled clinical trial that will randomize 300 Latino adults over the age of 55 years with diabetes who are cared for in 4 public clinics affiliated with the Martin Luther KingDrew University Medical Center Randomization will occur at the patient level The primary endpoints for the trial will be 1 differences in glycemic control as reflected by mean difference in hemoglobin A1c over time for the intervention versus usual care control group and 2 difference in diabetes-specific quality of life over time The trial will also measure a number of important secondary endpoints both before and after exposure to the intervention self-efficacy knowledge about diabetes self-care behaviors diabetes-specific symptoms quality of life low density lipoprotein levels blood pressure weight quality of care and costs Variables that are likely to modify the effectiveness of the intervention will also be examined including acculturation language insurance status and social support These data will provide the needed information to evaluate both the effectiveness and the cost effectiveness of the patient-centered intervention among Latino adults with diabetes In summary by modifying and testing an empowerment intervention that focuses on the patient we hope to arm Latino adults with diabetes with the needed self-efficacy knowledge and self-care skills to have the best possible glycemic control and process of health care regardless of the resources available in their care setting
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 |
|---|---|---|---|
| 5R01DK059527-04 | NIH | None | httpsreporternihgovquickSearch5R01DK059527-04 |