HypertensionNCT00388817
Improving Medication Use in Patients With Hypertension
A study testing Pharmacist intervention in people with Hypertension, run by University of North Carolina at 1 site in United States.
Trial summary
The purpose of this trial is to determine whether minority and low-income patients with high blood pressure take their medications better when they are helped by a pharmacist and provided with special medication packaging and information aimed at persons with low health literacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Pharmacist intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 492 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to May 2005
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- plan to receive health care and prescriptions at study facility
- prescribed at least one blood pressure medication
- English-speaking
- access to a telephone
- no hearing impairments in the normal range of conversation
Who cannot join
- dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Pharmacy, UNC-Chapel Hill, CB 7360
Chapel Hill, North Carolina, 27599-7360
About this study
The purpose of this trial is to determine whether minority and low-income patients with high blood pressure take their medications better when they are helped by a pharmacist and provided with special medication packaging and information aimed at persons with low health literacy.
Read the detailed description
Optimal use of medications in patients with hypertension prevents adverse outcomes. When their blood pressure is carefully controlled, patients with uncomplicated hypertension are spared primary events including myocardial infarction, stroke, cognitive impairment, and renal insufficiency. Patients who have already experienced complications are spared the suffering of subsequent events. Because hypertension is asymptomatic and antihypertensive drugs have adverse effects, patients often feel better when they are not taking their medication as opposed to when they carefully adhere to their physician's prescribed regimen. Therefore, innovative strategies are needed to educate patients and improve patient adherence to a complicated regimen often involving many drugs. Doing so can to reduce morbidity, mortality, and the costs of patient care. Minority patients often do not have access to the resources needed to assist them with their medications and as such they are especially vulnerable. Recent studies suggest that blood pressure control of patients with hypertension improves when pharmacists provide patients with education and monitoring. However, studies of clinical endpoints have not been conducted. This study aims to develop and test, in a randomized controlled trial, a multileveled pharmacy-based program to improve adherence in minority patients. This program incorporates patient education materials and medication packaging designed for patients with low-literacy. A study pharmacist accessed a computer database that is integrated into an electronic medical database called the Regenstrief Medical Record System (RMRS).
Patients from Wishard Health Services with uncomplicated or complicated hypertension were randomly assigned to a pharmacist intervention or usual care group. Patients in the intervention group received verbal education, written education materials, icon-based labeling of medication containers, and therapeutic monitoring. The pharmacist educated patients about their medications, identified barriers to appropriate drug use, coached patients to overcome drug use barriers, and coordinated drug use for these patients in conjunction with their primary care providers. Patients in the usual care (control) group did not receive pharmacist intervention.
To objectively measure medication compliance, Medication Event Monitor System (MEMS) lids (electronic monitors) were used for all antihypertensive medications. MEMS lids contain a computer chip that electronically imprints a time/date stamp each time an opening and closure occurs. Such data reveal the temporal pattern of medication adherence. Data concerning clinical endpoints, comorbidities, and healthcare costs were extracted from the RMRS. Other data included blood pressure measurements, health related quality of life, cognitive function, health literacy, and satisfaction with care.
Study participation for the patients in the intervention group concluded after 12 months of active intervention, which be followed by six months of post-intervention follow-up. Primary endpoints included medication adherence and systolic and diastolic blood pressures. Secondary outcomes included health-related quality of life, symptoms, patient satisfaction, and direct healthcare costs.
- Conditions
- Hypertension
- Being tested
- Pharmacist intervention
- Keywords
- Hypertension, Blood pressure, Adherence, Compliance, Pharmacist, Pharmacy, Costs
- Medical subject headings
- Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to blood pressure medications
Blood pressure control
Secondary outcomes (4)
Health-related quality of life
Exacerbation of symptoms
Patient satisfaction
Direct costs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startJan 2002
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- 492 participants
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Indiana University, Wishard Health Services
- Investigators
- Michael D Murray, PharmD, MPH, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388817
- Sponsor's protocol ID
- R01HL069399
- Status last verified
- Oct 2006
- First submitted
- 8 Oct 2006
- Last updated
- 17 Oct 2006
- Results posted
- No
Publications
Murray MD, Ritchey ME, Wu J, Tu W. Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch Intern Med. 2009 Apr 27;169(8):757-63. doi: 10.1001/archinternmed.2009.59.
PubMed 19398687
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Use in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT00388817
- Acronym / sponsor ID
- R01HL069399
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure, Adherence, Compliance, Pharmacist, Pharmacy, Costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Indiana University, Wishard Health Services
- Study start
- Jan 2002
- Study completion
- May 2005
- First posted
- 17 Oct 2006 (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 trial is to determine whether minority and low-income patients with high blood pressure take their medications better when they are helped by a pharmacist and provided with special medication packaging and information aimed at persons with low health literacy.
Detailed description
Optimal use of medications in patients with hypertension prevents adverse outcomes. When their blood pressure is carefully controlled, patients with uncomplicated hypertension are spared primary events including myocardial infarction, stroke, cognitive impairment, and renal insufficiency. Patients who have already experienced complications are spared the suffering of subsequent events. Because hypertension is asymptomatic and antihypertensive drugs have adverse effects, patients often feel better when they are not taking their medication as opposed to when they carefully adhere to their physician's prescribed regimen. Therefore, innovative strategies are needed to educate patients and improve patient adherence to a complicated regimen often involving many drugs. Doing so can to reduce morbidity, mortality, and the costs of patient care. Minority patients often do not have access to the resources needed to assist them with their medications and as such they are especially vulnerable. Recent studies suggest that blood pressure control of patients with hypertension improves when pharmacists provide patients with education and monitoring. However, studies of clinical endpoints have not been conducted. This study aims to develop and test, in a randomized controlled trial, a multileveled pharmacy-based program to improve adherence in minority patients. This program incorporates patient education materials and medication packaging designed for patients with low-literacy. A study pharmacist accessed a computer database that is integrated into an electronic medical database called the Regenstrief Medical Record System (RMRS).
Patients from Wishard Health Services with uncomplicated or complicated hypertension were randomly assigned to a pharmacist intervention or usual care group. Patients in the intervention group received verbal education, written education materials, icon-based labeling of medication containers, and therapeutic monitoring. The pharmacist educated patients about their medications, identified barriers to appropriate drug use, coached patients to overcome drug use barriers, and coordinated drug use for these patients in conjunction with their primary care providers. Patients in the usual care (control) group did not receive pharmacist intervention.
To objectively measure medication compliance, Medication Event Monitor System (MEMS) lids (electronic monitors) were used for all antihypertensive medications. MEMS lids contain a computer chip that electronically imprints a time/date stamp each time an opening and closure occurs. Such data reveal the temporal pattern of medication adherence. Data concerning clinical endpoints, comorbidities, and healthcare costs were extracted from the RMRS. Other data included blood pressure measurements, health related quality of life, cognitive function, health literacy, and satisfaction with care.
Study participation for the patients in the intervention group concluded after 12 months of active intervention, which be followed by six months of post-intervention follow-up. Primary endpoints included medication adherence and systolic and diastolic blood pressures. Secondary outcomes included health-related quality of life, symptoms, patient satisfaction, and direct healthcare costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and older
- plan to receive health care and prescriptions at study facility
- prescribed at least one blood pressure medication
- English-speaking
- access to a telephone
Key exclusion criteria (1 listed)
- dementia
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 |
|---|---|---|
| Pharmacist intervention | Behavioural | – |
Primary outcome
Adherence to blood pressure medications
Blood pressure control
4 secondary outcomes
Health-related quality of life
Exacerbation of symptoms
Patient satisfaction
Direct costs
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 17 Oct 2006.
- Derived from this study: PubMed 19398687Murray MD, Ritchey ME, Wu J, Tu W. Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch Intern Med. 2009 Apr 27;169(8):757-63. doi: 10.1001/archinternmed.2009.59.
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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.
Michael D Murray, PharmD, MPH principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist intervention in people with Hypertension, run by University of North Carolina 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 6 inclusion and 1 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 17 Oct 2006. 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.
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?
Adherence to blood pressure medications. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00388817, which also lists 1 linked publication.
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 17 Oct 2006.