NCT00119938

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 20, 2008

Status Verified

July 1, 2007

First QC Date

July 6, 2005

Last Update Submit

August 19, 2008

Conditions

Diabetes Mellitus, Type 2

Keywords

Disease managementPatient access to recordsMedical records systems, computerizedQuestionnairesPhysician-patient relationsMedical records

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Qualitative assessment of the program by patients and medical staff

    Interviews after 9 months of deployment

  • Biological markers of diabetes care (hemoglobin A1c, blood pressure, LDL cholesterol)

    Incidentally obtained over 9 months of care

Interventions

Access to online patient portalBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Stephen E Ross, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

September 1, 2004

Study Completion

December 1, 2006

Last Updated

August 20, 2008

Record last verified: 2007-07

Locations

US(1)