An interventional study of Statin Choice Decision Aid and Control Pamphlet in Diabetes, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 152 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 763 studies on the registry; 180 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligible providers are
Eligible patients
Exclusion Criteria:
Ineligible patients
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.
Other: Statin Choice Decision Aid
Control Pamphlet the provider meets with the patient to discuss treatment options in the usual fashion.
Other: Control Pamphlet
Paper based instrument with pictures indicating level of risk.
ADA Diabetes Sheet
Morisky medication adherence scale
Time frame: 3 months
Morisky medication adherence scale
Time frame: 6 months
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai