HypercholesterolemiaMWV_CAPSNCT01744977
Cholesterol Medication Packaging Study
A study testing packaging in people with Hypercholesterolemia, run by Durham VA Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- packaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Durham VAMC
Durham, North Carolina, 27701
Raleigh Community-based Outpatient Clinic (CBOC- Raleigh)
Raleigh, North Carolina, 27701
About this study
Official title: Evaluate the Efficacy, Perceptions and Cost of an Innovative Cholesterol Packaging
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.
Read the detailed 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)
- Conditions
- Hypercholesterolemia
- Being tested
- packaging
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
packagingBehavioural
Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol Medication Adherence
Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups
Measured: 12 months
Secondary outcomes (1)
Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months
obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months)
Measured: Baseline, 6months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durham VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hayden B Bosworth, PhD, Principal investigator, Duke University Medical Center/Durham VA Medical Center, Health Services and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744977
- Sponsor's protocol ID
- 01642
- Acronym
- MWV_CAPS
- Status last verified
- Apr 2016
- First submitted
- 5 Dec 2012
- Last updated
- 18 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy, Perceptions and Cost of an Innovative Cholesterol Packaging
- ClinicalTrials.gov ID
- NCT01744977
- Acronym / sponsor ID
- MWV_CAPS / 01642
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Durham VA Medical CenterUS federal agency
- Study start
- Dec 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Posted 18 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence Packaging Intervention Group | Experimental | Behavioral: packaging[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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| packagingIntervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles | Behavioural | Adherence Packaging Intervention Group |
Primary outcome
Cholesterol Medication Adherence
Time frame: 12 months
Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups
1 secondary outcome
Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months
Time frame: Baseline, 6months, 12months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayden B Bosworth, PhD principal investigator
Duke University Medical Center/Durham VA Medical Center, Health Services and Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing packaging in people with Hypercholesterolemia, run by Durham VA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol Medication Adherence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.