Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220207
Status:
COMPLETED
Last Update Posted:
2007-08-01
First Post:
2005-09-15
Brief Title:
Determining the Effect on Patients of Internet-Based Diabetes Disease Management
Sponsor:
Robert Wood Johnson Foundation
Organization:
Robert Wood Johnson Foundation
Study Overview
Official Title:
A Randomized Controlled Trial of Diabetes Disease Management Over the Internet
Status:
COMPLETED
Status Verified Date:
2007-07
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 grant supports a 12-month randomized controlled trial comparing usual care versus collaborative disease management over the Internet among disadvantaged African-Americans with Type 2 diabetes The project aims to 1 determine the effect of case-managed Web-based diabetes care on glycemic control health care utilization self-efficacy and patient satisfaction and 2 qualitatively identify enablers of the successful use of computers the Internet and e-Health applications by disadvantaged patients
Detailed Description:
We propose to conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management over the Internet among disadvantaged African-Americans with type 2 diabetes Subjects will be recruited from patients receiving primary care at Harborview Medical Center the County facility administered by the University of Washington in Seattle As part of a pretest-posttest experimental design 30 intervention subjects will be trained to use an existing diabetes disease-management module comprising six Web sites that are accessed from home via links displayed within the Universitys MyUW Internet portal These sites allow patients to
1 View their entire electronic medical record the same record used by providers
2 Upload blood glucose readings stored in a digital meter
3 Enter medication nutrition and exercise information into an online daily diary
4 Communicate with providers regarding treatment recommendations or other questions using clinical e-mail
5 Obtain additional information from a traditional patient education site with endorsed content and
6 Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy
All data can be viewed by patients and providers in online trended displays that a clinical pharmacist will use to review cases no less often than weekly As an attention control 30 subjects will also be trained to use a provided personal computer to access Internet knowledge resources but will not have access to the case-management services and module being evaluated By comparing the two groups we aim to
1 Determine the effect of case-managed Web-based diabetes care on glycemic control healthcare utilization self-efficacy and patient satisfaction and
2 Use semi-structured interviews among a subsample of both trial arms to qualitatively identify enablers of the successful use of computers the Internet and e-health applications by disadvantaged patients
1 View their entire electronic medical record the same record used by providers
2 Upload blood glucose readings stored in a digital meter
3 Enter medication nutrition and exercise information into an online daily diary
4 Communicate with providers regarding treatment recommendations or other questions using clinical e-mail
5 Obtain additional information from a traditional patient education site with endorsed content and
6 Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy
All data can be viewed by patients and providers in online trended displays that a clinical pharmacist will use to review cases no less often than weekly As an attention control 30 subjects will also be trained to use a provided personal computer to access Internet knowledge resources but will not have access to the case-management services and module being evaluated By comparing the two groups we aim to
1 Determine the effect of case-managed Web-based diabetes care on glycemic control healthcare utilization self-efficacy and patient satisfaction and
2 Use semi-structured interviews among a subsample of both trial arms to qualitatively identify enablers of the successful use of computers the Internet and e-health applications by disadvantaged patients
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