Medication Non-AdherenceNCT01078285
Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor
An observational study of Medication Non-Adherence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in United States.
Trial summary
Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Medication Non-Adherence
- What is being tested?
- No Patient Counseling and Adherence Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to Nov 2011
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Male and female aged >21 years * Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute * Signed informed consent
Who may be able to join
- Male and female aged >21 years
- Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
- Signed informed consent
Who cannot join
- Unwilling to give written informed consent
- Failed statin treatment in the past
- Switched from another statin to atorvastatin because of co-pay program
- Participated in an earlier Market Research study on Impact of cholesterol management behaviors post in-clinic adherence intervention
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Prairie Heart Institute
Springfield, Illinois, 62701
Memorial Medical Center
Springfield, Illinois, 62702
Prairie Diagnostic Center
Springfield, Illinois, 62702
About this study
Official title: Impact Of An Integrated Intervention Program On Adherence To Atorvastatin
Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.
- Conditions
- Medication Non-Adherence
- Being tested
- No Patient Counseling, Adherence Counseling
- Keywords
- Integrated program on adherence using counseling, support services including cost-sharing where appropriate and educational materials mailed monthly.
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Patient CounselingBehavioural
Patients do not receive any adherence counseling, or other patient support services
Adherence CounselingBehavioural
Patients receive 3-5 minutes of adherence counseling, and other patient support services
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Behavioral: No Patient Counseling | |
| Intervention Arm | Not described Receives: Behavioral: Adherence Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Days Covered (PDC)
Measured: 180 days
Secondary outcomes (4)
Medication Possession Ratio (MPR)
Measured: 180 days
Persistence-the number of continuous days a patient is supplied with medication using the allowable grace period or gap (30 or 60 days).
Measured: 180 days
Percent of patients that are at least 80% adherent (PDC>0.8)
Measured: 180 days
Percent of patients who fill at least one atorvastatin prescription during the period of study
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Non-AdherenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078285
- Sponsor's protocol ID
- A2581184
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2010
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of An Integrated Intervention Program On Adherence To Atorvastatin
- ClinicalTrials.gov ID
- NCT01078285
- Acronym / sponsor ID
- A2581184
- Conditions
- Medication Non-Adherence
- Keywords
- Integrated program on adherence using counseling, support services including cost-sharing where appropriate and educational materials mailed monthly.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Mar 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.
Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Behavioral: No Patient Counseling |
| Intervention Arm | – | Behavioral: Adherence Counseling |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Male and female aged >21 years * Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute * Signed informed consent
Key inclusion criteria (3 listed)
- Male and female aged >21 years
- Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
- Signed informed consent
Key exclusion criteria (4 listed)
- Unwilling to give written informed consent
- Failed statin treatment in the past
- Switched from another statin to atorvastatin because of co-pay program
- Participated in an earlier Market Research study on Impact of cholesterol management behaviors post in-clinic adherence intervention
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 |
|---|---|---|
| No Patient CounselingPatients do not receive any adherence counseling, or other patient support services | Behavioural | Control |
| Adherence CounselingPatients receive 3-5 minutes of adherence counseling, and other patient support services | Behavioural | Intervention Arm |
Primary outcome
Proportion of Days Covered (PDC)
Time frame: 180 days
4 secondary outcomes
Medication Possession Ratio (MPR)
Time frame: 180 days
Persistence-the number of continuous days a patient is supplied with medication using the allowable grace period or gap (30 or 60 days).
Time frame: 180 days
Percent of patients that are at least 80% adherent (PDC>0.8)
Time frame: 180 days
Percent of patients who fill at least one atorvastatin prescription during the period of study
Time frame: 180 days
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 18 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Non-Adherence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 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 3 inclusion and 4 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Proportion of Days Covered (PDC) (time frame: 180 days). 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 Feb 2021.