Comparison of Two Programs to Improve Blood Pressure Treatment Adherence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00123058
First received: July 20, 2005
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Hypertension
Behavioral: Nurse administered
Device: BP Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Take Control of Your Blood Pressure (TCYB)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • BP measurement [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction with care [ Time Frame: Measured at 6 and 24 months ] [ Designated as safety issue: No ]
  • Risk associated with hypertension [ Time Frame: Measured at 6 and 24 months ] [ Designated as safety issue: No ]
  • Self reported adherence [ Time Frame: Measured at 6 and 24 months ] [ Designated as safety issue: No ]
  • Efficacy with treatment [ Time Frame: Measured at 6 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 777
Study Start Date: June 2003
Estimated Study Completion Date: June 2015
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nurse administered

Nurse Administered Intervention:

Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months.

Behavioral: Nurse administered
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
Experimental: Nurse & BP monitor
Subjects received both a nurse administered behavioral intervention via telephone every 8 weeks for 24 months and a study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
Behavioral: Nurse administered
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
Device: BP Monitor
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
No Intervention: Usual Care
Subjects received neither home BP monitor nor nurse phone intervention.
Experimental: Home BP Monitor
Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
Device: BP Monitor
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.

Detailed Description:

BACKGROUND:

High BP is a major health problem, which contributes to high levels of morbidity and mortality. Elevated BP levels are a major risk factor for stroke, coronary artery disease (CAD), congestive heart failure (CHF), and kidney disease. In the United States, stroke rates are no longer improving and CHF and kidney failure rates continue to increase. Despite the availability of effective treatment, only 25% of individuals with high BP are able to control it effectively. The reasons for poor BP control vary; however, a predominant reason is poor adherence to medication instructions and life-style modification recommendations. This study will address these two sources of poor BP control through a real world, multifaceted approach.

DESIGN NARRATIVE:

This study will compare a nurse-administered tailored program to a home BP monitoring program to evaluate the impact each program has on BP control. The 5-year randomized controlled study will take place in a primary care setting and will enroll individuals with high BP. The nurse-administered program will be based on the principles of the Health Decision Model and will be designed to increase awareness, yet be easily integrated into the participant's medical care so as to enhance adherence with the prescribed treatment. The use of home BP monitors has been found to be associated with increased self management, medication adherence, and improved BP control.

Five hundred seventy individuals with high BP from two primary care clinics will be randomly assigned to receive either the nurse-administered program, home BP monitoring program, both programs, or regular medical care. Based on an initial assessment, participants assigned to the nurse-administered program will be involved in a behavioral education telephone program to promote medication adherence. This program will include support, reminders, and information on the risks of high BP, health behaviors, patient/doctor communication, literacy, and side effects. Participants will receive continuous education and will be monitored and supported to enhance medication adherence. Participants assigned to the home BP monitors will record their BP every other day and mail the results to the study physicians. The primary outcome will be whether or not the participant's BP is greater than 140/90 mm Hg (for non-diabetic individuals) or greater than 130/85 mm Hg (for diabetic individuals) at 6-month intervals over 24 months (5 total measurements). Descriptive statistics will be computed for all study variables stratified by treatment group. Because each participant may have a different number of measurements, the study physicians will model the responses and evaluate the programs using a mixed effects model for dichotomous outcomes. Based upon preliminary data, this study will improve participants' management of high BP, decrease health care utilization, and subsequently improve BP control.

Additionally, a subset (n=250) of those enrolled and randomized to either the nurse administered program or usual care will be evaluated separately on the programs's effect on both primary (blood pressure control) and secondary outcome measures (changes in hypertension risk perception,satisfaction with care, patient confidence following recommended regimen, and self-reported adherence to recommended regimens.) Masking for this is open label.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Visited Duke General Internal Medicine Primary Care Clinic at Pickett Road or Duke Outpatient Clinic between April 2003 and April 2004
  • Diagnosed with high BP
  • Currently residing in an eight county area, including Durham County, NC and surrounding counties
  • Currently taking BP medication
  • Receives most medical care at the Duke Primary Care clinics
  • Able to speak and understand English over the phone

Exclusion Criteria:

  • Diagnosed with dementia
  • Diagnosed with Parkinson's Disease
  • Diagnosed with atrial fibrillation
  • Diagnosed with end stage kidney disease
  • Hospitalized for stroke, heart attack, or coronary artery revascularization in the 3 months prior to study entry
  • Diagnosed with metastatic cancer in the 3 months prior to study entry
  • Receiving kidney dialysis
  • Pregnant or expecting to become pregnant in the 2 years following study entry
  • Currently residing in a nursing home or receiving home health care
  • Severely impaired speech or hearing
  • Participating in another blood pressure study
  • Has another family member participating in this study
  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: NCT00123058

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Pfizer
Investigators
Principal Investigator: Hayden B. Bosworth Duke University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00123058     History of Changes
Obsolete Identifiers: NCT00129103
Other Study ID Numbers: Pro00005845, R01HL070713, R01 HL70713
Study First Received: July 20, 2005
Last Updated: August 16, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
Hypertension
Cariovascular Diseases
Health Illiteracy

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014