Clinical trial NCT00105898: Internet-based Diabetes Education and Case Management
Official title: Internet-based Diabetes Education and Case Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Keywords: Diabetes mellitus
Hypertension
Telemedicine
Case management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-03-18
Enrollment: 152
Sex: ALL
Minimum age (years): 25
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in HbA1c at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.
timeFrame: 12 months
Other outcomes:
Locations:
city: Brockton
country: United States
facility: VA Boston Healthcare System Brockton Campus, Brockton, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Brockton Campus, Brockton, MA
name: Paul R. Conlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/ajcn/88.2.255. No abstract available.
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. doi: 10.1007/s11606-007-0247-8. Epub 2007 Jun 6.
citation: McMahon GT, Fonda SJ, Gomes HE, Alexis G, Conlin PR. A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes. Diabetes Technol Ther. 2012 Nov;14(11):1060-7. doi: 10.1089/dia.2012.0137. Epub 2012 Sep 6.