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| Name | Class |
|---|---|
| Rhode Island Foundation | OTHER |
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The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDIC | Experimental | Multidisciplinary education and diabetes intervention for cardiac risk reduction |
|
| usual care | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral counseling and peer support | Behavioral | Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L). | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Chih Wu, MD | Providence VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence VAMC | Providence | Rhode Island | 02908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19966072 | Result | Taveira TH, Friedmann PD, Cohen LB, Dooley AG, Khatana SA, Pirraglia PA, Wu WC. Pharmacist-led group medical appointment model in type 2 diabetes. Diabetes Educ. 2010 Jan-Feb;36(1):109-17. doi: 10.1177/0145721709352383. Epub 2009 Dec 4. | |
| 19614793 | Derived | Khatana SA, Taveira TH, Choudhary G, Eaton CB, Wu WC. Change in hemoglobin A(1c) and C-reactive protein levels in patients with diabetes mellitus. J Cardiometab Syndr. 2009 Spring;4(2):76-80. doi: 10.1111/j.1559-4572.2008.00042.x. |
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Once eligibility confirmed and consent signed, participants were randomized. There were no wash-out or run-in period.
Eligible patients were identified by a combination of the review of the VA Medical Center's electronic medical record system and referral by primary care providers. Recruitment started July 2004 and enrollment was completed by May 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | MEDIC | Multidisciplinary education and diabetes intervention for cardiac risk reduction Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention Role modeling : learning from peers with similar disease and problems Interactive Education : interactive lectures with hands-on learning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Interactive Education | Behavioral | interactive lectures with hands-on learning |
|
| Role modeling | Behavioral | learning from peers with similar disease and problems |
|
| Pharmacologic case management | Procedure | provided by clinical pharmacists following pre-established algorithms |
|
| FG001 | Usual Care | usual care |
| COMPLETED |
|
| NOT COMPLETED |
|
Age, mean in years; Gender, % male; Baseline level of glycemic control
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| ID | Title | Description |
|---|---|---|
| BG000 | MEDIC | Multidisciplinary education and diabetes intervention for cardiac risk reduction Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention Role modeling : learning from peers with similar disease and problems Interactive Education : interactive lectures with hands-on learning |
| BG001 | Usual Care | usual care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L). | Posted | Number | percentage | 4 months |
|
|
|
Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
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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 | MEDIC | Multidisciplinary education and diabetes intervention for cardiac risk reduction Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention Interactive Education: interactive lectures with hands-on learning Role modeling: learning from peers with similar disease and problems Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms | 0 | 58 | 11 | 58 | ||
| EG001 | Usual Care | usual care | 1 | 51 | 2 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Systematic Assessment | was admitted into the hospital for abnormal nonspecific EKG findings from 1/25/06 until 2/1/06 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | seen in the emergency room on 7/25/05 for lower back pain |
| |
| Syncope | Cardiac disorders | Systematic Assessment | seen in the emergency room and admitted on 7/14/05 for syncope |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | seen in the emergence room for cough |
| |
| Cellulitis Abcess | Skin and subcutaneous tissue disorders | Systematic Assessment | was seen in the emergency room on 9/14/05 for cellulitis, hypertension and skin abscess. |
| |
| Laceration | Skin and subcutaneous tissue disorders | Systematic Assessment | was seen in the emergency room on 10/2/05 for a laceration |
| |
| Blepharitis | Eye disorders | Systematic Assessment | was seen in the emergency room on 8/19/05 for blepheritis |
| |
| Toe infection | Skin and subcutaneous tissue disorders | Systematic Assessment | was seen in the emergency room on 11/17/05 for a toe infection |
| |
| Ear ache | Ear and labyrinth disorders | Systematic Assessment | was seen in the emergency room on 1/2/06 for an ear and headache |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | was seen in the emergency room, on 11/19/05 for acute bronchitis |
| |
| hypertension | Cardiac disorders | Systematic Assessment | was seen in the emergency room on 12/1/05 for hypertension |
| |
| hematuria | Renal and urinary disorders | Systematic Assessment | was seen in the emergency room on 2/1/06 for hematuria and abdominal pain |
| |
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment | was seen in the emergency room on 2/7/06 for rash |
| |
| hypoglycemia | Blood and lymphatic system disorders | Systematic Assessment | was seen in the emergency room on 5/29/07 for hypoglycemia |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wen-Chih Wu, MD; Principal Investigator | Providence VA Medical Center | 4012737100 | 6237 | wen-chih.wu@va.gov |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| >=65 years |
|
| Male |
|
| Diastolic Blood Pressure<80mmHg |
|
| LDL Cholesterol <100mg/dL |
|