The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

NCT00548639 | Completed

• 3 other identifiers: 06-1415ISRCTN12345678NCI-793-0115D
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• Morisky medication adherence scale

  3 months

• Morisky medication adherence scale

  6 months

Study Arms (2)

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.

Other: Statin Choice Decision Aid

Usual Care

SHAM COMPARATOR

Control Pamphlet the provider meets with the patient to discuss treatment options in the usual fashion.

Other: Control Pamphlet

Interventions

Statin Choice Decision Aid OTHER

Paper based instrument with pictures indicating level of risk.

Statin Choice

Control Pamphlet OTHER

ADA Diabetes Sheet

Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible providers are
• Internists and nurse practitioners
• Provide care for patients with type 2 diabetes
• Do not plan to relocate outside the practice in the next 6 months.
• Eligible patients
• Have a diagnosis of type 2 diabetes mellitus \> 1 month confirmed by provider or the medical chart
• Do not take statins, but their providers identify them as eligible for this medication
• Are currently taking statins

You may not qualify if:

• Ineligible patients
• Have, in the providers' judgment, major barriers such as hearing impairment or dementia that would compromise their participation in shared decisionmaking;
• are not available for follow-up 3 months after randomization
• are pregnant
• are under age 21

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Devin Mann, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (1)