Cardiovascular DiseasesPhase 2NCT00796172
Evaluating the Effectiveness of a Computerized Medication Adherence System at Reducing Cardiovascular Disease Risk Factors
A Phase 2 study testing Medication Adherence System (MAS) in people with Cardiovascular Diseases, run by PHCC LP at 1 site in United States.
Trial summary
High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and it is important for people with these conditions to adhere to their medication regimens. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Medication Adherence System (MAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2010
- Phase
- Phase 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed one or more antihypertensive and/or lipid management medications
- Living independently
- Has a literacy level that will enable them to successfully navigate the MAS and read associated reports (i.e., approximately a sixth grade reading level)
Who cannot join
- Current substance use or abuse
- Recent (in the 6 months before study entry) heart attack, stroke, peripheral vascular disease, or other medical condition that limits a potential participant's ability to complete the necessary visits to the outpatient clinic site, to use the MAS, and to complete study assessments
- Residing in assisted living or a nursing home situation
- Medical condition for which survival is expected to be unlikely in the 1 year after study entry
- Unable to read or use a computer with a computer mouse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinic-based Intervention to Improve Medication Adherence to Reduce Cardiovascular Disease Risks
High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and it is important for people with these conditions to adhere to their medication regimens. This study will evaluate the effectiveness of a computerized program that provides individualized feedback to participants and their doctors for increasing medication adherence among people at risk of developing CVD.
Read the detailed description
CVD is a disorder that affects the heart's ability to function normally. The most common cause of CVD is narrowing or blockage of the coronary arteries, which supply blood to the heart. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. For people who take blood pressure and cholesterol lowering medications, adherence to their medication regimen is another important factor in reducing the risk of CVD. Currently, there are no programs available to assist patients with tracking their medication adherence, despite the fact that non-adherence is a major reason for elevated cholesterol and blood pressure levels. This study will evaluate a computerized medication adherence system (MAS) that provides individualized reports to participants and their doctors with information on identifying and overcoming barriers to medication adherence. The MAS will be evaluated in conjunction with counseling from participants' doctors. The purpose of this study is to evaluate the effectiveness of a computerized MAS plus counseling from doctors for increasing medication adherence and lowering blood pressure and cholesterol levels among people at risk of CVD.
This 1-year study will enroll people with high blood pressure or cholesterol levels who are at risk of CVD. At a baseline study visit, participants will undergo blood pressure measurements, a blood collection, and a medication review. Participants will be randomly assigned to either the MAS group or a usual care group. Participants in the MAS group will use the computerized MAS program and answer questions about their medication regimens. Reports will then be generated for both the participants and their doctors. Participants will meet with their doctors to review the reports and discuss their medications and CVD risks. Participants in the usual care group will receive written materials on CVD risk factors, and they will receive usual care from their doctors. At a 6-month visit, participants in the MAS group will undergo a medication review, blood pressure measurements, and interviews with study staff. They will also enter their medication information into the MAS and meet with their doctors to discuss the generated report. Participants in the usual care group will not take part in any study procedures at 6 months. At a 12-month visit, all participants will undergo blood pressure measurements, a blood collection, and a medication review. Participants in the MAS group will also complete questionnaires to assess the usefulness of the MAS computer program.
- Conditions
- Cardiovascular Diseases
- Being tested
- Medication Adherence System (MAS), Usual Care
- Keywords
- Hypertension, High Blood Pressure, Blood Lipid Management
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Adherence System (MAS)Behavioural
Participants will receive individualized reports from the MAS and counseling from their doctors. The counseling will focus on adherence to blood pressure and cholesterol management medications.
Usual CareBehavioural
Participants will receive usual care from their doctors and written materials on CVD risk factors.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Medication adherence system (MAS) plus counseling from doctors Receives: Behavioral: Medication Adherence System (MAS) |
| 2 | Active comparator | Usual care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence and associated changes in blood pressure and lipid profiles
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHCC LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, James G. Christian, PHCC LP
- Investigators
- James G. Christian, MSW, MABS, Principal investigator, PHCC LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796172
- Sponsor's protocol ID
- 601
- Other IDs
- R44HL090111, 2R44HL090111-02
- Status last verified
- Apr 2015
- First submitted
- 21 Nov 2008
- Last updated
- 29 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-based Intervention to Improve Medication Adherence to Reduce Cardiovascular Disease Risks
- ClinicalTrials.gov ID
- NCT00796172
- Acronym / sponsor ID
- 601
- Conditions
- Cardiovascular Diseases
- Keywords
- Hypertension, High Blood Pressure, Blood Lipid Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- PHCC LPIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Nov 2008 (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.
High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and it is important for people with these conditions to adhere to their medication regimens. This study will evaluate the effectiveness of a computerized program that provides individualized feedback to participants and their doctors for increasing medication adherence among people at risk of developing CVD.
Detailed description
CVD is a disorder that affects the heart's ability to function normally. The most common cause of CVD is narrowing or blockage of the coronary arteries, which supply blood to the heart. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. For people who take blood pressure and cholesterol lowering medications, adherence to their medication regimen is another important factor in reducing the risk of CVD. Currently, there are no programs available to assist patients with tracking their medication adherence, despite the fact that non-adherence is a major reason for elevated cholesterol and blood pressure levels. This study will evaluate a computerized medication adherence system (MAS) that provides individualized reports to participants and their doctors with information on identifying and overcoming barriers to medication adherence. The MAS will be evaluated in conjunction with counseling from participants' doctors. The purpose of this study is to evaluate the effectiveness of a computerized MAS plus counseling from doctors for increasing medication adherence and lowering blood pressure and cholesterol levels among people at risk of CVD.
This 1-year study will enroll people with high blood pressure or cholesterol levels who are at risk of CVD. At a baseline study visit, participants will undergo blood pressure measurements, a blood collection, and a medication review. Participants will be randomly assigned to either the MAS group or a usual care group. Participants in the MAS group will use the computerized MAS program and answer questions about their medication regimens. Reports will then be generated for both the participants and their doctors. Participants will meet with their doctors to review the reports and discuss their medications and CVD risks. Participants in the usual care group will receive written materials on CVD risk factors, and they will receive usual care from their doctors. At a 6-month visit, participants in the MAS group will undergo a medication review, blood pressure measurements, and interviews with study staff. They will also enter their medication information into the MAS and meet with their doctors to discuss the generated report. Participants in the usual care group will not take part in any study procedures at 6 months. At a 12-month visit, all participants will undergo blood pressure measurements, a blood collection, and a medication review. Participants in the MAS group will also complete questionnaires to assess the usefulness of the MAS computer program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Medication Adherence System (MAS)Medication adherence system (MAS) plus counseling from doctors |
| 2 | Active comparator | Behavioral: Usual CareUsual care |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prescribed one or more antihypertensive and/or lipid management medications
- Living independently
- Has a literacy level that will enable them to successfully navigate the MAS and read associated reports (i.e., approximately a sixth grade reading level)
Key exclusion criteria (5 listed)
- Current substance use or abuse
- Recent (in the 6 months before study entry) heart attack, stroke, peripheral vascular disease, or other medical condition that limits a potential participant's ability to complete the necessary visits to the outpatient clinic site, to use the MAS, and to complete study assessments
- Residing in assisted living or a nursing home situation
- Medical condition for which survival is expected to be unlikely in the 1 year after study entry
- Unable to read or use a computer with a computer mouse
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 System (MAS)Participants will receive individualized reports from the MAS and counseling from their doctors. The counseling will focus on adherence to blood pressure and cholesterol management medications. | Behavioural | 1 |
| Usual CareParticipants will receive usual care from their doctors and written materials on CVD risk factors. | Behavioural | 2 |
Primary outcome
Medication adherence and associated changes in blood pressure and lipid profiles
Time frame: Measured at Year 1
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 29 Apr 2015.
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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.
James G. Christian, MSW, MABS principal investigator
PHCC LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medication Adherence System (MAS) in people with Cardiovascular Diseases, run by PHCC LP 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 3 inclusion and 5 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 29 Apr 2015. 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 phase mean?
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 and associated changes in blood pressure and lipid profiles (time frame: Measured at Year 1). 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 29 Apr 2015.