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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00105898 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Internet-Based Diabetes Education and Case Management |
Enrollment: | 152 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Intervention group
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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
Procedure: Telephone and face-to-face care management
Participants interact with a care manager via face-to-face and telephone contact
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2: Active Comparator
Comparator
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Procedure: Internet access alone
Participants are given internet access and encouraged to seek diabetes information to help in their self management
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Background:
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.
Objectives:
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.
Methods:
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 ER visits/hospitalizations during the study period).
We will study 150 participants with elevated HbA1c ( 8.5%). Over 12-months we will measure HbA1c, office 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.
Status:
152 participants were enrolled. Participant involvement has ended. Study data are being analyzed.
Ages Eligible for Study: | 25 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
VA Medical Center, Jamaica Plain Campus | |
Boston, Massachusetts, United States, 02130 |
Principal Investigator: | Paul R. Conlin, MD | VA Medical Center, Jamaica Plain Campus |
Responsible Party: | Department of Veterans Affairs ( Conlin, Paul - Principal Investigator ) |
Study ID Numbers: | TEL 02-100 |
Study First Received: | March 17, 2005 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00105898 History of Changes |
Health Authority: | United States: Federal Government |
Diabetes mellitus Hypertension Telemedicine Case management |
Metabolic Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Hypertension |
Metabolic Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Cardiovascular Diseases Glucose Metabolism Disorders Hypertension |