Comparison of Two Programs to Improve Blood Pressure Treatment Adherence

NCT00123058

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27705, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular Diseases, Heart Diseases, Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Cardiovascular Diseases, Heart Diseases, HypertensionComparison of Two Programs to Improve Blood Pressure Treatment Adherence
NCT00123058
  1. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison of Two Programs to Improve Blood Pressure Treatment Adherence
Official Title  ICMJE Take Control of Your Blood Pressure (TCYB)
Brief Summary The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Nurse administered

    Nurse Administered Intervention:

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

    Intervention: Behavioral: Nurse administered
  • 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.
    Interventions:
    • Behavioral: Nurse administered
    • Device: BP Monitor
  • 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.
    Intervention: Device: BP Monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2013)
777
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123058
Other Study ID Numbers  ICMJE Pro00005845
R01HL070713 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Hayden B. BosworthDuke University
PRS Account Duke University
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP