An Online System to Improve Diabetes Self-Care

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

D-STAR (Diabetes-System To Access Records): An Online Patient Portal to Improve and Sustain Diabetes Self-Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119938
• Other study ID #: 51758
• Status: Completed
• Phase: N/A
• First received: July 6, 2005
• Last updated: August 19, 2008
• Start date: September 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2007
• Source: Robert Wood Johnson Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke).

Description:

Patient portals are online programs that can provide a number of functions for patients, among them:

• Ability to request appointments, referrals, and medication refills;

• Ability to send secure electronic messages to medical staff, and to receive replies;

• Access to the medical record;

• Disease management

We are comparing two patient portals with different sets of features to determine if personalized information and guidance can improve self-care and measures of diabetes-related health. Self-care measures will be assessed using standardized questionnaires at baseline, 3, and 6 months. Chart review will be used to assess measures of diabetes-related health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Type 2 diabetes mellitus

• Has access to Internet

• Has e-mail address

• Established patient at one of four participating practices at University of Colorado Hospital

Exclusion Criteria:

• Non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Access to online patient portal

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measure of diabetes self-care activities, developed from the Summary of Diabetes Self-Care Measure		Surveys at baseline, 3 months, and 6 months
Secondary	Qualitative assessment of the program by patients and medical staff		Interviews after 9 months of deployment
Secondary	Biological markers of diabetes care (hemoglobin A1c, blood pressure, LDL cholesterol)		Incidentally obtained over 9 months of care

External Links

•   Website for Health e-Technologies Initiative, a national program office of the Robert Wood Johnson Foundation
•   Website for University of Colorado Hospital, the site of the study