Cholesterol Medication Packaging Study

NCT01744977 | Completed Results

• 1 other identifier: 01642
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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 (\<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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Cholesterol Medication Adherence

  Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups

  12 months

Secondary Outcomes (1)

• Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months

  Baseline, 6months, 12months

Study Arms (2)

Adherence Packaging Intervention Group

EXPERIMENTAL

\[MeadWestvaco Packaging Intervention Arm\] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.

Behavioral: packaging

Education Only Group

NO INTERVENTION

Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. The 6-month interval was selected to maintain contact with patients.

Interventions

packaging BEHAVIORAL

Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles

Adherence Packaging Intervention Group

Eligibility Criteria

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

You may qualify if:

• Enrolled in one of three Durham VA Medical Center (DVAMC) Primary Care clinics for at least one year
• AT least one visit to a primary care provider at the Raleigh Community Based Outpatient Clinic (CBOC) or DVAMC associated primary care clinics in the previous 12 months
• Outpatient diagnostic code for hypercholesterolemia
• uncontrolled LDL in the last 12 months and/or poor LDL refill defined as \<80% medication adherence in the last 12 months
• prescribed whole tablets of simvastatin, rosuvastatin or pravastatin

You may not qualify if:

• Diagnosis of metastatic cancer.
• Active diagnosis of dementia documented in medical record.
• Active diagnosis of psychosis documented in medical record with admission with last 30days.
• Treated with dialysis
• Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in past month.
• Severely impaired hearing, speech or sight. (Patients must be able to respond to phone calls and review adherence literature)
• Participating in another on-going cardio- vascular disease (CVD) risk management study (i.e., pharmaceutical trial or behavioral intervention)
• Does not have access to a telephone
• Resident in nursing facility that manages patients medications or
• Receiving home health care for extended period (home health service for limited time period will not exclude, i.e. scheduled surgical procedure not expected to require care for longer than 30 days)
• Planning to leave the area prior to the anticipated end of participation in the study.

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (2)

Durham VAMC

Durham, North Carolina, 27701, United States

Location

Raleigh Community-based Outpatient Clinic (CBOC- Raleigh)

Raleigh, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Product Packaging

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Industry; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Hayden Bosworth, PhD
• Organization: Durham Veterans Affairs Medical Center

hayden.bosworth@va.gov

919-286-6936

Study Officials

• Hayden B Bosworth, PhD

  Duke University Medical Center/Durham VA Medical Center, Health Services and Development

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 7, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 18, 2016
• Results First Posted: May 18, 2016

Record last verified: 2016-04

Locations

US (2)