Internet-based Diabetes Education and Case Management

Study Overview
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Brief Summary
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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
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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

Official Title
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Internet-based Diabetes Education and Case Management

Conditions
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Diabetes Mellitus, Hypertension

Intervention / Treatment
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* Procedure: Web-based care management
* Procedure: Telephone and face-to-face care management
* Procedure: Internet access alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Intervention group | Procedure: Web-based care management<br>* Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters<br>|
| Active Comparator: Arm 2<br>Comparator | Procedure: Telephone and face-to-face care management<br>* Participants interact with a care manager via face-to-face and telephone contact<br>|
| Sham Comparator: Arm 3<br>Comparator | Procedure: Internet access alone<br>* Participants are given internet access and encouraged to seek diabetes information to help in their self management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c at 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Hypertension, Telemedicine, Case management