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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hypertension
Diabetes Mellitus
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014