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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN12345678 | |||
| NCI-793-0115D |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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Diabetes is a growing epidemic within the United States that disproportionately affects economically disadvantaged communities like East Harlem. As diabetic patients are at very high risk for heart disease, experts recommend an aggressive approach towards using statins in people with diabetes. However, statins and other helpful drugs are only effective if patients decide to take them. Adherence to this medication is notoriously poor and is aggravated by its required life-long use. This study is designed to test the effectiveness of a new decision aid in helping diverse, inner-city patients with diabetes understand the risks and benefits in taking statins and whether this enhanced decision making process improves their adherence to the medication.
To compare the efficacy of usual consultations with or without the decision aid STATIN CHOICE in type 2 diabetic patients using or considering using statins to lower CV risk in terms of statin use, adherence, knowledge, beliefs and decisional conflict. The study team's primary hypothesis is that 3 months after the index discussion, significantly more patients randomized to STATIN CHOICE are using statins, are adherent to statins, are knowledgeable about the statin choice, and are satisfied with their decision than patients randomized to usual care consultation, and that these benefits will be achieved without deterioration in quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin Choice | Experimental | Statin Choice Decision Aid The provider will introduce the patient to the choice of statins using the decision aid. The patient may make a choice then or defer this choice; in all cases, the patient goes home with the Statin Choice decision aid and pamphlet. |
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| Usual Care | Sham Comparator | Control Pamphlet the provider meets with the patient to discuss treatment options in the usual fashion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin Choice Decision Aid | Other | Paper based instrument with pictures indicating level of risk. |
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| Measure | Description | Time Frame |
|---|---|---|
| Morisky medication adherence scale | 3 months | |
| Morisky medication adherence scale | 6 months |
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Inclusion Criteria:
Eligible providers are
Eligible patients
Exclusion Criteria:
Ineligible patients
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| Name | Affiliation | Role |
|---|---|---|
| Devin Mann, MD, MS | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Control Pamphlet | Other | ADA Diabetes Sheet |
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