HypercholesterolemiaPhase 1/2NCT01227330
Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
A Phase 1/2 study testing Medication adherence intervention in people with Hypercholesterolemia and Medication Adherence, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this study is to pilot test a behavioral medication adherence (MA) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypercholesterolemia, Medication Adherence
- What is being tested?
- Medication adherence intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 or older at the time of study entry,
- Take a once-daily prescription statin medication for ≥ 6 months with no changes to statin prescription for at least 30 days prior to study entry,
- A score of ≤ 9 on the Short Blessed Test,
- Participants must self-administer his or her own medications without prompts from any other person or device.
- Baseline medication adherence rate of ≤ 90%.
- Participants agree to complete all study contacts and measurements, including the use of a special medication bottle with a Medication Event Monitoring System (MEMS) cap for the duration of the study.
- Able to open and close MEMS caps.
Who cannot join
- Participant's medications are managed by someone other than the participant
- Participant is unable or unwilling to use MEMS caps.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to pilot test a behavioral medication adherence (MA) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia.
Read the detailed description
This study will answer the following primary research question:
- What is the estimated effect size of a behavioral MA intervention on MA rates in older adults who are poorly adherent to statin medications? The study will also explore the following secondary research questions:
- What is the estimated effect size of a behavioral MA intervention on low-density lipoprotein cholesterol (LDL-C) levels in older adults?
- What is the estimated effect size of a behavioral MA intervention on high-density lipoprotein cholesterol (HDL-C) levels in older adults?
- What is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?
- Conditions
- Hypercholesterolemia, Medication Adherence
- Being tested
- Medication adherence intervention, Attention-control
- Medical subject headings
- Hypercholesterolemia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication adherence interventionBehavioural
12-week behavioral feedback intervention to improve adherence to statin medication
Attention-controlBehavioural
Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Medication adherence intervention | Experimental | Receives 12-week behavioral feedback intervention to improve adherence to statin medication Receives: Behavioral: Medication adherence intervention |
| Control | No intervention | No intervention |
| Attention-control | Active comparator | Receives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol Receives: Behavioral: Attention-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Measured: 6 months
Secondary outcomes (1)
Serum cholesterol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Ruppar, PhD, RN, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227330
- Sponsor's protocol ID
- MU HSIRB 1174637
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2010
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
- ClinicalTrials.gov ID
- NCT01227330
- Acronym / sponsor ID
- MU HSIRB 1174637
- Conditions
- Hypercholesterolemia, Medication Adherence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
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 this study is to pilot test a behavioral medication adherence (MA) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia.
Detailed description
This study will answer the following primary research question:
- What is the estimated effect size of a behavioral MA intervention on MA rates in older adults who are poorly adherent to statin medications? The study will also explore the following secondary research questions:
- What is the estimated effect size of a behavioral MA intervention on low-density lipoprotein cholesterol (LDL-C) levels in older adults?
- What is the estimated effect size of a behavioral MA intervention on high-density lipoprotein cholesterol (HDL-C) levels in older adults?
- What is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medication adherence intervention | Experimental | Behavioral: Medication adherence interventionReceives 12-week behavioral feedback intervention to improve adherence to statin medication |
| Control | No intervention | –No intervention |
| Attention-control | Active comparator | Behavioral: Attention-controlReceives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60 or older at the time of study entry,
- Take a once-daily prescription statin medication for ≥ 6 months with no changes to statin prescription for at least 30 days prior to study entry,
- A score of ≤ 9 on the Short Blessed Test,
- Participants must self-administer his or her own medications without prompts from any other person or device.
- Baseline medication adherence rate of ≤ 90%.
Key exclusion criteria (2 listed)
- Participant's medications are managed by someone other than the participant
- Participant is unable or unwilling to use MEMS caps.
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 |
|---|---|---|
| Medication adherence intervention12-week behavioral feedback intervention to improve adherence to statin medication | Behavioural | Medication adherence intervention |
| Attention-controlHealth education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group | Behavioural | Attention-control |
Primary outcome
Medication adherence
Time frame: 6 months
1 secondary outcome
Serum cholesterol
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
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RecruitingObservational study
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A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
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Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
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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.
Todd Ruppar, PhD, RN principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Medication adherence intervention in people with Hypercholesterolemia and Medication Adherence, run by University of Missouri-Columbia at 1 site 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 7 inclusion and 2 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication adherence (time frame: 6 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 24 Oct 2016.