N/A
Completed N=240
Cholesterol Medication Packaging Study
Source: ClinicalTrials.gov NCT01744977 ↗Enrolled (actual)
240
Serious AEs
24.6%
Results posted
May 2016
Primary outcomePrimary: Cholesterol Medication Adherence — .99; .94 adherence proportion — p=0.300
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cholesterol Medication Adherence |
.99; .94 | 0.300 |
| SECONDARY Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months |
110.1; 111.6; 101.1; 105.8; 101.3; 102.9 | 0.839 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01744977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.