Improving Medication Use in Patients With Hypertension

This study has been completed.
Sponsor:
Collaborators:
Indiana University School of Medicine
Wishard Health Services
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00388817
First received: October 8, 2006
Last updated: October 16, 2006
Last verified: October 2006
  Purpose

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 Intervention
Hypertension
Behavioral: Pharmacist intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Medication Use in Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Adherence to blood pressure medications
  • Blood pressure control

Secondary Outcome Measures:
  • Health-related quality of life
  • Exacerbation of symptoms
  • Patient satisfaction
  • Direct costs

Estimated Enrollment: 492
Study Start Date: January 2002
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388817

Locations
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
Indiana University School of Medicine
Wishard Health Services
Investigators
Principal Investigator: Michael D Murray, PharmD, MPH UNC-Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00388817     History of Changes
Other Study ID Numbers: R01-HL69399
Study First Received: October 8, 2006
Last Updated: October 16, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Hypertension
Blood pressure
Adherence
Compliance
Pharmacist
Pharmacy
Costs

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014