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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Hypertension
Procedure: Web-based care management
Procedure: Telephone and face-to-face care management
Procedure: Internet access alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-based Diabetes Education and Case Management

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in HbA1c at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 152
Study Start Date: February 2005
Study Completion Date: June 2010
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Intervention group
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
Active Comparator: Arm 2
Comparator
Procedure: Telephone and face-to-face care management
Participants interact with a care manager via face-to-face and telephone contact
Sham Comparator: Arm 3
Comparator
Procedure: Internet access alone
Participants are given internet access and encouraged to seek diabetes information to help in their self management

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   25 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105898

Sponsors and Collaborators
Investigators
Principal Investigator: Paul R. Conlin, MD VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105898     History of Changes
Other Study ID Numbers: TEL 02-100
Study First Received: March 17, 2005
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes mellitus
Hypertension
Telemedicine
Case management

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014