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| ID | Type | Description | Link |
|---|---|---|---|
| Department of Defense | Other Grant/Funding Number | W81XWH-10-2-0057 |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.
The long-term goal is to develop a practical and sustainable system of diabetes management that will help low income patients achieve and maintain goals within established treatment guidelines regardless of geographic location. This randomized clinical trial will employ the innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management (TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM). The target population will be low income patients served in Federally Qualified Health Care Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care) and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6 months, with study visits at baseline, 3, and 6 months. The primary outcome will be Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be blood pressure control and quality of life (qol) at 6 months post-randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | The usual care group received the current standards of care at the study clinics. | |
| Technology Assisted Case Management | Experimental | The TACM group used the FORA 2-in-1 Telehealth system for diabetes management intervention to link a case manager to patients with poorly controlled type 2 diabetes in real time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-Assisted Case Management | Behavioral | The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse case manager will have access to a secure server to which the uploaded measurements are stored in real time. Medications are titrated under supervision of a primary care and endocrinology physicians |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) at 6 Months Post Randomization | Hemoglobin A1c (HbA1c) was measured at 6 months post randomization | 6 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard E Egede, MD, MS | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin C. Fetter Family Health Center, Inc. | Charleston | South Carolina | 29403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22014122 | Background | Egede LE, Strom JL, Fernandes J, Knapp RG, Rojugbokan A. Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial. Trials. 2011 Oct 20;12:231. doi: 10.1186/1745-6215-12-231. | |
| 28581821 | Result | Egede LE, Williams JS, Voronca DC, Knapp RG, Fernandes JK. Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes. Diabetes Technol Ther. 2017 Aug;19(8):476-482. doi: 10.1089/dia.2017.0006. Epub 2017 Jun 5. |
| Label | URL |
|---|---|
| Protocol Paper | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy. |
| FG001 | Technology-assisted Case Management (TACM) | This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach. Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin A1c (HbA1c) at 6 Months Post Randomization | Hemoglobin A1c (HbA1c) was measured at 6 months post randomization | Final analysis used baseline A1c analysis of covariance for differences in levels of A1c at 6 months between the treatment groups with baseline A1c as covariate. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | 6 months post randomization |
|
6month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Campbell | Medical College of Wisconsin | 4149558829 | jacampbell@mcw.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Primary Outcomes Paper | View source |
| BG001 | Technology-assisted Case Management (TACM) | This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach. Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Technology-assisted Case Management (TACM) | This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach. Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. |
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| 0 |
| 59 |
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| 59 |
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| 59 |
| EG001 | Technology-assisted Case Management (TACM) | This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach. Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients assigned the FORA 2- | 0 | 54 | 0 | 54 | 0 | 54 |
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