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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Intervention group |
|
| Arm 2 | Active Comparator | Comparator |
|
| Arm 3 | Sham Comparator | Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based care management | Procedure | Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c at 12 months | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul R. Conlin, MD | VA Boston Healthcare System Brockton Campus, Brockton, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Brockton Campus, Brockton, MA | Brockton | Massachusetts | 02301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18689358 | Result | 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. | |
| 17551796 | Result | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Telephone and face-to-face care management | Procedure | Participants interact with a care manager via face-to-face and telephone contact |
|
| Internet access alone | Procedure | Participants are given internet access and encouraged to seek diabetes information to help in their self management |
|
| 22953754 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |