Patients with diabetes and elevated HbA1c are at the greatest 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. A web-based system might neutralize access barriers to care management such as scheduling and travel to appointments and be of particular help in improving diabetes care. We will examine the efficacy and cost-effectiveness of two methods of diabetes education and care management- a traditional model that involves face-to-face encounters and telephone contact and an Internet-based model using a diabetes care management web site. We will compare these interventions to a usual care control group that receives no education or care management but is provided with Internet access. This study employs a randomized, prospective, parallel group design involving patients with diabetes mellitus. Primary outcome measures include clinical data (e.g. HbA1c, blood pressure, quality of life questionnaires) and secondary outcome measures include economic data (e.g. costs of case management, medication usage, and number(s) of emergency room (ER) visits/hospitalizations during the study period).

We will study 135 participants with elevated HbA1c (>= 8.5%). Over 12-months, we will measure HbA1c, office blood pressure (BP), and scores on the Problem Areas in Diabetes (PAID) questionnaire and Center for Epidemiologic Studies Depression Scale (CES-D). Participants receiving usual care will receive a notebook computer and Internet access. Those assigned to Internet-based care management will receive a notebook computer, Internet access and will interact with a care manager through a diabetes education and care management web site. Those receiving traditional care management will interact with a care manager following a structured contact schedule. Both care management models will employ medication algorithms to improve glucose and BP control, with the secondary goal of also improving diabetes-related stress and depression. We will collect data on process measures and health care utilization in order to conduct exploratory analyses on the cost-effectiveness of these interventions.

Condition	Treatment or Intervention
Diabetes Mellitus	Behavior: Interaction with care manager by internet

Further Study Details: 

Primary Outcomes: Clinical data (e.g., HbA1c, blood pressure, quality of life questionnaires)
Secondary Outcomes: Economic data (e.g., costs of case management, medication usage, and number(s) of ER visits/hospitalizations during the study period)
Expected Total Enrollment:  135

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Elevated HbA1c (>= 8.5%)
• Patients with poorly controlled diabetes who are otherwise generally well and who are willing to engage with the technological management program

Paul R Conlin, MD      617-232-9500  Ext. 4233    Paul.Conlin@med.va.gov

Massachusetts
      VA Boston Healthcare System, Brockton,  Massachusetts,  02301,  United States; Recruiting

Study ID Numbers:  TEL 02-100
Record last reviewed:  March 2005
Last Updated:  March 17, 2005
Record first received:  March 17, 2005
ClinicalTrials.gov Identifier:  NCT00105898
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08