Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194558
Status:
COMPLETED
Last Update Posted:
2008-10-02
First Post:
2005-09-12
Brief Title:
Outcomes and Cost Consequences of Using an Internet Co-Management Module to Improve the Quality of Type 1 Diabetes Care
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Outcomes and Cost Consequences of Using an Internet Co-Management Module to Improve the Quality of Type 1 Diabetes Care
Status:
COMPLETED
Status Verified Date:
2008-09
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 researchers will conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management using the Internet among patients with type 1 diabetes receiving care in the Diabetes Care Center at the University of Washington
Detailed Description:
We will conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management using the Internet among patients with type 1 diabetes on multiple daily injections with insulin glargine and rapid-acting analogs Specifically the objectives of the study are to
1 Evaluate the difference in glycemic control HbA1c between intervention and control
2 Evaluate the difference in resource utilization and costs of care between intervention and control and
3 Evaluate the difference in satisfaction with care between intervention and control
A total of 80-85 subjects will be recruited from patients receiving care in the Diabetes Care Center DCC at the University of Washington in Seattle As part of a pretest-posttest experimental design intervention-group subjects will be trained in the use of an existing diabetes disease-management module comprising six related 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 including clinical reminders the same record used by providers
2 Upload blood glucose readings stored in a digital meter
3 Manually enter medication nutrition and exercise data into an online daily diary
4 Communicate with providers regarding treatment recommendations or other questions using a clinical e-mail service
5 Obtain additional information from a traditional education site whose content and links were sanctioned by the Medical Director of the DCC and
6 Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy
In addition to login and password protection access to confidential information from home requires the use of secondary authentication SecureID All clinical and other data can be viewed by patients and providers in online trended displays that will be used by a nurse practitioner to review cases no less than weekly As the control group subjects receiving usual care will not have access to the diabetes module and related case-management services being evaluated
The primary clinical outcome for the study is the between group differences in glycemic control using HbA1c as the metric A co-primary outcome is all direct medical care utilization Satisfaction with diabetes care employing both a quantitative survey Patient Assessment of Chronic Illness Care and semi-structured interviews performed on a 20 purposive sub-sample of intervention patients is a secondary outcome measure
1 Evaluate the difference in glycemic control HbA1c between intervention and control
2 Evaluate the difference in resource utilization and costs of care between intervention and control and
3 Evaluate the difference in satisfaction with care between intervention and control
A total of 80-85 subjects will be recruited from patients receiving care in the Diabetes Care Center DCC at the University of Washington in Seattle As part of a pretest-posttest experimental design intervention-group subjects will be trained in the use of an existing diabetes disease-management module comprising six related 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 including clinical reminders the same record used by providers
2 Upload blood glucose readings stored in a digital meter
3 Manually enter medication nutrition and exercise data into an online daily diary
4 Communicate with providers regarding treatment recommendations or other questions using a clinical e-mail service
5 Obtain additional information from a traditional education site whose content and links were sanctioned by the Medical Director of the DCC and
6 Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy
In addition to login and password protection access to confidential information from home requires the use of secondary authentication SecureID All clinical and other data can be viewed by patients and providers in online trended displays that will be used by a nurse practitioner to review cases no less than weekly As the control group subjects receiving usual care will not have access to the diabetes module and related case-management services being evaluated
The primary clinical outcome for the study is the between group differences in glycemic control using HbA1c as the metric A co-primary outcome is all direct medical care utilization Satisfaction with diabetes care employing both a quantitative survey Patient Assessment of Chronic Illness Care and semi-structured interviews performed on a 20 purposive sub-sample of intervention patients is a secondary outcome measure
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