Cholesterol Medication Packaging Study — MWV_CAPS  

Hypercholesterolemia Clinical Trial

Official title: Evaluate the Efficacy, Perceptions and Cost of an Innovative Cholesterol Packaging

Status Completed

Clinical Trial Summary

The purpose of the overall study is to improve medication use rates among veterans by looking at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve patients who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their medications based on how often they refilled their medications in the last 12 months.

The investigators will test an innovative adherence packaging relative to usual care. The primary hypothesis is that veterans who receive the intervention will have greater improvement in their medication adherence as measured by pill refill at 6 and 12 months of follow up as compared to the control group.

Clinical Trial Description

A sample of participants with elevated LDL level >130 mg/dl and/or <80% medication position ratio in the last 12 months (n=250) will be consented. The study sample will consist of both male and female subjects. Research assistants (RA's) will complete a baseline assessment and then randomly allocated participants to one of the following two groups:

• MeadWestvaco (MWV) Packaging Intervention. Patients randomized to the intervention group will receive the MWV medication adherence packaging and adherence education (Packaging Education.) at baseline from a research pharmacist. The participant will then receive their prescribed cholesterol medication in the MWV packaging over the next 12 months.

• The Education only Group - Patients randomized to the control group will receive educational material about LDL reduction at baseline.

The study includes the following contacts with participants.

• Recruitment letter

• Telephone screening

• Baseline consent and interview - In person for all participants [Only Adherence Packaging Intervention participants will receive baseline discussion and education from the research pharmacist]

• 6 month outcome assessment follow-up - In person for all participants

• 12 month outcome assessment follow-up - In person for all participants

• 12 month phone interview - Optional recorded qualitative interview for intervention participants only.

All participants enrolled in study will be followed for 12 months.

The study includes the following contacts with providers

• Baseline consent and explanation of the adherence packaging - In person for all providers (group style visit) ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypercholesterolemia

• NCT number: NCT01744977
• Study type: Interventional
• Source: Durham VA Medical Center
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Completion date: August 2015