Internet-based Diabetes Education and Case Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105898
First received: March 17, 2005
Last updated: October 25, 2013
Last verified: August 2010

March 17, 2005
October 25, 2013
February 2005
April 2007   (final data collection date for primary outcome measure)
Change in HbA1c at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Clinical data (e.g., HbA1c, blood pressure, quality of life questionnaires)
Complete list of historical versions of study NCT00105898 on ClinicalTrials.gov Archive Site
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Economic data (e.g., costs of case management, medication usage, and number(s) of ER visits/hospitalizations during the study period)
Not Provided
Not Provided
 
Internet-based Diabetes Education and Case Management
Internet-based Diabetes Education and Case Management

This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.

Background:

Patients with diabetes and elevated hemoglobin A1c (HbA1c) are at risk for diabetes-related complications. Care-management may be helpful in these patients, by providing direct contact between such high-risk patients and the healthcare system. Web-based systems have previously shown promise as a means of neutralizing access barriers such as scheduling and travel to appointments and may be of particular help in improving diabetes care.

Objectives:

We examined the efficacy of two methods of diabetes education and care management: (1) a traditional model that involved telephone contact and face-to-face encounters (2) a web-based model with access to a diabetes care management web site. We compared these interventions to a study group that received no education or care management but was provided with a computer and access to diabetes self-management websites.

Methods:

This study employed a randomized, parallel group design involving patients with diabetes mellitus and an elevated HbA1c ( 8.5%). Participants assigned to web-based care management received a notebook computer, Internet access and interacted with a care manager through a diabetes education and care management website. Participants receiving telephone-based care management interacted with a care manager using telephone and face-to-face contact. Both care management models employed medication algorithms to improve glucose and BP control. These care management groups were compared to a study group that had no care management but received a notebook computer and Internet access with their "home page" containing links to a series of diabetes self-management websites (i.e. computer only group). The primary outcome measures were HbA1c, blood pressure, and scores on the Problem Areas in Diabetes (PAID) questionnaire, each measured over 12-months.

Status:

Complete

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Hypertension
  • Procedure: Web-based care management
    Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters
  • Procedure: Telephone and face-to-face care management
    Participants interact with a care manager via face-to-face and telephone contact
  • Procedure: Internet access alone
    Participants are given internet access and encouraged to seek diabetes information to help in their self management
  • Experimental: Arm 1
    Intervention group
    Intervention: Procedure: Web-based care management
  • Active Comparator: Arm 2
    Comparator
    Intervention: Procedure: Telephone and face-to-face care management
  • Sham Comparator: Arm 3
    Comparator
    Intervention: Procedure: Internet access alone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
June 2010
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of diabetes mellitus
  • Age 25-79 years
  • HbA1c >=8.5%
  • Ability to speak and understand English
  • Telephone access
  • VA-based primary care provider
  • Interest in using a glucose and BP monitor and notebook computer

Exclusion Criteria:

  • Visual impairment that affects ability to read
Both
25 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00105898
TEL 02-100
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Paul R. Conlin, MD VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
Department of Veterans Affairs
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP