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| Name | Class |
|---|---|
| Academy of Nutrition and Dietetics | OTHER |
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This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED randomized control trial. The study is being conducted by the Minneapolis Heart Institute Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).
The study will examine the impact of a registered dietitian-led, primary care integrated, telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c <8%, not using tobacco and taking an aspirin as appropriate.
Individuals will be invited to attend a baseline visit where they will have lab work done, anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment. They will formally consent to participation by signing a study consent form. The same measures will be collected after completion of the one year study.
Study participants will receive two sessions of free lab work, a diabetes education book, and brief coaching with a registered dietitian/certified diabetes educator. In addition, those randomized to the phone coaching will have access to a registered dietitian/certified diabetes educator on a monthly basis for one year of personalized health coaching for free. The intent of this coaching is to help individuals achieve diabetes "optimal" care or meeting all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin use).
This program is designed to complement usual clinic-based primary care, with coaches documenting lab, biometrics and medication adjustments in the EHR, along with documenting phone encounters and communicating directly with patients' PCPs as needed. Documentation in the EHR uses an order created specifically for the study indicating the patient's research status.
Lab work required as part of this research study at baseline and 12 months is covered by the study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month study visits are the responsibility of the patient and/or their insurance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals |
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| Standard of Care | No Intervention | Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching | Behavioral | Focus on nutrition, activity and appropriate medication use and adherence |
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| Measure | Description | Time Frame |
|---|---|---|
| A1c (Laboratory Assessment) | The count of participants represents the number of individuals meeting A1c less than 8% at follow up | 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings) | The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up | 1 year |
| Tobacco Use (Self-reported Questionnaire) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Miedema, MD | Minneapolis Heart Institute Foundation | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30711463 | Derived | Benson GA, Sidebottom A, Hayes J, Miedema MD, Boucher J, Vacquier M, Sillah A, Gamam S, VanWormer JJ. Impact of ENHANCED (diEtitiaNs Helping pAtieNts CarE for Diabetes) Telemedicine Randomized Controlled Trial on Diabetes Optimal Care Outcomes in Patients with Type 2 Diabetes. J Acad Nutr Diet. 2019 Apr;119(4):585-598. doi: 10.1016/j.jand.2018.11.013. Epub 2019 Jan 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals Coaching: Focus on nutrition, activity and appropriate medication use and adherence |
| FG001 | Standard of Care | Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals Coaching: Focus on nutrition, activity and appropriate medication use and adherence |
| 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 | A1c (Laboratory Assessment) | The count of participants represents the number of individuals meeting A1c less than 8% at follow up | Posted | Count of Participants | Participants | 1 year |
|
1 year
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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 | Intervention | Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals Coaching: Focus on nutrition, activity and appropriate medication use and adherence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Population Health Program Manager | Minneapolis Heart Institute Foundation | 612-863-4222 | gbenson@mhif.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2016 | May 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The count of participants represents those not using tobacco at follow up
| 1 year |
| Statin Use (as Noted in EMR) | The count of participants represents those taking a statin as indicated at follow up | 1 year |
| Aspirin Use (as Noted in EMR) | The count of participants represents taking aspirin as indicated at follow up | 1 year |
| BG001 | Standard of Care | Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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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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| Region of Enrollment | Number | participants |
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Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
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| Other Pre-specified | Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings) | The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up | Posted | Count of Participants | Participants | 1 year |
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| Other Pre-specified | Tobacco Use (Self-reported Questionnaire) | The count of participants represents those not using tobacco at follow up | Posted | Count of Participants | Participants | 1 year |
|
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| Other Pre-specified | Statin Use (as Noted in EMR) | The count of participants represents those taking a statin as indicated at follow up | Posted | Count of Participants | Participants | 1 year |
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| Other Pre-specified | Aspirin Use (as Noted in EMR) | The count of participants represents taking aspirin as indicated at follow up | Posted | Count of Participants | Participants | 1 year |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Standard of Care | Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need | 0 | 58 | 0 | 58 | 0 | 58 |
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| D004700 | Endocrine System Diseases |