Internet-based Diabetes Education and Case Management
Primary Purpose
Diabetes Mellitus, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based care management
Telephone and face-to-face care management
Internet access alone
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes mellitus, Hypertension, Telemedicine, Case management
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
Sites / Locations
- VA Boston Healthcare System Brockton Campus, Brockton, MA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Intervention group
Comparator
Comparator
Outcomes
Primary Outcome Measures
Change in HbA1c at 12 months
Secondary Outcome Measures
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.
Full Information
NCT ID
NCT00105898
First Posted
March 17, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00105898
Brief Title
Internet-based Diabetes Education and Case Management
Official Title
Internet-based Diabetes Education and Case Management
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension
Keywords
Diabetes mellitus, Hypertension, Telemedicine, Case management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Intervention group
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Comparator
Arm Title
Arm 3
Arm Type
Sham Comparator
Arm Description
Comparator
Intervention Type
Procedure
Intervention Name(s)
Web-based care management
Intervention Description
Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters
Intervention Type
Procedure
Intervention Name(s)
Telephone and face-to-face care management
Intervention Description
Participants interact with a care manager via face-to-face and telephone contact
Intervention Type
Procedure
Intervention Name(s)
Internet access alone
Intervention Description
Participants are given internet access and encouraged to seek diabetes information to help in their self management
Primary Outcome Measure Information:
Title
Change in HbA1c at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul R. Conlin, MD
Organizational Affiliation
VA Boston Healthcare System Brockton Campus, Brockton, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Brockton Campus, Brockton, MA
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18689358
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.
Results Reference
result
PubMed Identifier
17551796
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.
Results Reference
result
PubMed Identifier
22953754
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.
Results Reference
derived
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Internet-based Diabetes Education and Case Management
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