An Online System to Improve Diabetes Self-Care - Full Text View

Sponsored by:	Robert Wood Johnson Foundation
Information provided by:	Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:	NCT00119938

Purpose

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).

Condition	Intervention
Diabetes Mellitus, Type 2	Behavioral: Access to online patient portal

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	D-STAR (Diabetes-System To Access Records): An Online Patient Portal to Improve and Sustain Diabetes Self-Care

Further study details as provided by Robert Wood Johnson Foundation:

Primary Outcome Measures:

Composite measure of diabetes self-care activities, developed from the Summary of Diabetes Self-Care Measure [ Time Frame: Surveys at baseline, 3 months, and 6 months ]

Secondary Outcome Measures:

Qualitative assessment of the program by patients and medical staff [ Time Frame: Interviews after 9 months of deployment ]
Biological markers of diabetes care (hemoglobin A1c, blood pressure, LDL cholesterol) [ Time Frame: Incidentally obtained over 9 months of care ]

Enrollment:	331
Study Start Date:	September 2004
Study Completion Date:	December 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119938

Locations

United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045

Sponsors and Collaborators

Robert Wood Johnson Foundation

Investigators

Principal Investigator:

Stephen E Ross, MD

University of Colorado at Denver and Health Sciences Center

More Information

Website for Colorado Health Outcomes Program, coordinator of study This link exits the ClinicalTrials.gov site

Website for Health e-Technologies Initiative, a national program office of the Robert Wood Johnson Foundation This link exits the ClinicalTrials.gov site

Website for University of Colorado Hospital, the site of the study This link exits the ClinicalTrials.gov site

Study ID Numbers:	51758
Study First Received:	July 6, 2005
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00119938
Health Authority:	United States: Institutional Review Board

Keywords provided by Robert Wood Johnson Foundation:

Disease management
Patient access to records
Medical records systems, computerized

Questionnaires
Physician-patient relations
Medical records

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009