Internet-based Diabetes Education and Case Management

Hypertension Clinical Trial

Official title:

Internet-based Diabetes Education and Case Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105898
• Other study ID #: TEL 02-100
• Status: Completed
• Phase: N/A
• First received: March 17, 2005
• Last updated: April 6, 2015
• Start date: February 2005
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 2010
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

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
• Telephone and face-to-face care management
Participants interact with a care manager via face-to-face and telephone contact
• Internet access alone
Participants are given internet access and encouraged to seek diabetes information to help in their self management

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Brockton Campus, Brockton, MA	Brockton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Conlin PR. Genes and environment in blood pressure control--salt intake again shows its importance. Am J Clin Nutr. 2008 Aug;88(2):255-6. — View Citation

Kerfoot BP, Conlin PR, Travison T, McMahon GT. Patient safety knowledge and its determinants in medical trainees. J Gen Intern Med. 2007 Aug;22(8):1150-4. Epub 2007 Jun 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c at 12 months		12 months	No
Secondary	Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.		12 months	No