Viewing Study NCT01744977



Ignite Creation Date: 2024-05-06 @ 1:08 AM
Last Modification Date: 2024-10-26 @ 11:00 AM
Study NCT ID: NCT01744977
Status: COMPLETED
Last Update Posted: 2016-05-18
First Post: 2012-12-05

Brief Title: Cholesterol Medication Packaging Study
Sponsor: Durham VA Medical Center
Organization: Durham VA Medical Center

Study Overview

Official Title: Evaluate the Efficacy Perceptions and Cost of an Innovative Cholesterol Packaging
Status: COMPLETED
Status Verified Date: 2016-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MWV_CAPS
Brief 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 130mgdl 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
Detailed Description: A sample of participants with elevated LDL level 130 mgdl andor 80 medication position ratio in the last 12 months n250 will be consented The study sample will consist of both male and female subjects Research assistants RAs 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None