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Improving Medication Use in Patients With Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388817
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : October 17, 2006
National Institutes of Health (NIH)
Indiana University School of Medicine
Wishard Health Services
Information provided by:
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Pharmacist intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Medication Use in Patients With Hypertension
Study Start Date : January 2002
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Adherence to blood pressure medications
  2. Blood pressure control

Secondary Outcome Measures :
  1. Health-related quality of life
  2. Exacerbation of symptoms
  3. Patient satisfaction
  4. Direct costs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388817

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United States, North Carolina
School of Pharmacy, UNC-Chapel Hill, CB 7360
Chapel Hill, North Carolina, United States, 27599-7360
Sponsors and Collaborators
University of North Carolina
National Institutes of Health (NIH)
Indiana University School of Medicine
Wishard Health Services
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Principal Investigator: Michael D Murray, PharmD, MPH UNC-Chapel Hill
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00388817    
Other Study ID Numbers: R01HL069399 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: October 17, 2006
Last Verified: October 2006
Keywords provided by University of North Carolina, Chapel Hill:
Blood pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases