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Comparison of Two Programs to Improve Blood Pressure Treatment Adherence

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse administered
BP Monitor
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Hypertension, Cariovascular Diseases, Health Illiteracy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

Experimental

Arm Label

Nurse administered

Nurse & BP monitor

Usual Care

Home BP Monitor

Arm Description

Nurse Administered Intervention: Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months.

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.

Subjects received neither home BP monitor nor nurse phone intervention.

Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.

Outcomes

Primary Outcome Measures

BP measurement

Secondary Outcome Measures

Satisfaction with care
Risk associated with hypertension
Self reported adherence
Efficacy with treatment

Full Information

First Posted
July 20, 2005
Last Updated
September 5, 2014
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00123058
Brief Title
Comparison of Two Programs to Improve Blood Pressure Treatment Adherence
Official Title
Take Control of Your Blood Pressure (TCYB)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension
Keywords
Hypertension, Cariovascular Diseases, Health Illiteracy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
777 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse administered
Arm Type
Experimental
Arm Description
Nurse Administered Intervention: Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months.
Arm Title
Nurse & BP monitor
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Subjects received neither home BP monitor nor nurse phone intervention.
Arm Title
Home BP Monitor
Arm Type
Experimental
Arm Description
Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
Intervention Type
Behavioral
Intervention Name(s)
Nurse administered
Intervention Description
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
Intervention Type
Device
Intervention Name(s)
BP Monitor
Intervention Description
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
Primary Outcome Measure Information:
Title
BP measurement
Time Frame
Measured at 6 months
Secondary Outcome Measure Information:
Title
Satisfaction with care
Time Frame
Measured at 6 and 24 months
Title
Risk associated with hypertension
Time Frame
Measured at 6 and 24 months
Title
Self reported adherence
Time Frame
Measured at 6 and 24 months
Title
Efficacy with treatment
Time Frame
Measured at 6 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayden B. Bosworth
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15797147
Citation
Bosworth HB, Olsen MK, Gentry P, Orr M, Dudley T, McCant F, Oddone EZ. Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. Patient Educ Couns. 2005 Apr;57(1):5-14. doi: 10.1016/j.pec.2004.03.011.
Results Reference
background
PubMed Identifier
16177452
Citation
Hong TB, Oddone EZ, Dudley TK, Bosworth HB. Subjective and objective evaluations of health among middle-aged and older veterans with hypertension. J Aging Health. 2005 Oct;17(5):592-608. doi: 10.1177/0898264305279780.
Results Reference
background
PubMed Identifier
16050862
Citation
Kim JW, Bosworth HB, Voils CI, Olsen M, Dudley T, Gribbin M, Adams M, Oddone EZ. How well do clinic-based blood pressure measurements agree with the mercury standard? J Gen Intern Med. 2005 Jul;20(7):647-9. doi: 10.1111/j.1525-1497.2005.0105.x.
Results Reference
background
PubMed Identifier
16045379
Citation
Hong TB, Franks MM, Gonzalez R, Keteyian SJ, Franklin BA, Artinian NT. A dyadic investigation of exercise support between cardiac patients and their spouses. Health Psychol. 2005 Jul;24(4):430-4. doi: 10.1037/0278-6133.24.4.430.
Results Reference
background
PubMed Identifier
15894959
Citation
Bosworth HB, Olsen MK, Oddone EZ. Improving blood pressure control by tailored feedback to patients and clinicians. Am Heart J. 2005 May;149(5):795-803. doi: 10.1016/j.ahj.2005.01.039. No abstract available.
Results Reference
background
PubMed Identifier
14677147
Citation
Bosworth HB, Bartash RM, Olsen MK, Steffens DC. The association of psychosocial factors and depression with hypertension among older adults. Int J Geriatr Psychiatry. 2003 Dec;18(12):1142-8. doi: 10.1002/gps.1026.
Results Reference
background
PubMed Identifier
18780175
Citation
Trivedi RB, Ayotte B, Edelman D, Bosworth HB. The association of emotional well-being and marital status with treatment adherence among patients with hypertension. J Behav Med. 2008 Dec;31(6):489-97. doi: 10.1007/s10865-008-9173-4. Epub 2008 Sep 9.
Results Reference
background
PubMed Identifier
18288540
Citation
Bosworth HB, Powers B, Grubber JM, Thorpe CT, Olsen MK, Orr M, Oddone EZ. Racial differences in blood pressure control: potential explanatory factors. J Gen Intern Med. 2008 May;23(5):692-8. doi: 10.1007/s11606-008-0547-7. Epub 2008 Feb 21.
Results Reference
background
PubMed Identifier
18401226
Citation
Powers BJ, Oddone EZ, Grubber JM, Olsen MK, Bosworth HB. Perceived and actual stroke risk among men with hypertension. J Clin Hypertens (Greenwich). 2008 Apr;10(4):287-94. doi: 10.1111/j.1751-7176.2008.07797.x.
Results Reference
background
PubMed Identifier
19424920
Citation
Ayotte BJ, Allaire JC, Bosworth H. The associations of patient demographic characteristics and health information recall: the mediating role of health literacy. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2009 Jul;16(4):419-32. doi: 10.1080/13825580902741336. Epub 2009 May 8.
Results Reference
background
PubMed Identifier
19920964
Citation
Voils CI, Sandelowski M, Dahm P, Blouin R, Bosworth HB, Oddone EZ, Steinhauser KE. Selective adherence to antihypertensive medications as a patient-driven means to preserving sexual potency. Patient Prefer Adherence. 2008 Feb 2;2:201-6. doi: 10.2147/ppa.s3796.
Results Reference
background
PubMed Identifier
19927132
Citation
Reed SD, Li Y, Oddone EZ, Neary AM, Orr MM, Grubber JM, Graham FL, Olsen MK, Svetkey LP, Dolor RJ, Powers BJ, Adams MB, Bosworth HB. Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension. Am J Hypertens. 2010 Feb;23(2):142-8. doi: 10.1038/ajh.2009.215. Epub 2009 Nov 19.
Results Reference
background
PubMed Identifier
20694185
Citation
Trivedi RB, Ayotte BJ, Thorpe CT, Edelman D, Bosworth HB. Is there a nonadherent subtype of hypertensive patient? A latent class analysis approach. Patient Prefer Adherence. 2010 Jul 21;4:255-62. doi: 10.2147/ppa.s11335.
Results Reference
background
PubMed Identifier
16996808
Citation
Bosworth HB, Olsen MK, Dudley T, Orr M, Neary A, Harrelson M, Adams M, Svetkey LP, Dolor RJ, Oddone EZ. The Take Control of Your Blood pressure (TCYB) study: study design and methodology. Contemp Clin Trials. 2007 Jan;28(1):33-47. doi: 10.1016/j.cct.2006.08.006. Epub 2006 Aug 16.
Results Reference
result
PubMed Identifier
18164894
Citation
Bosworth HB, Olsen MK, Neary A, Orr M, Grubber J, Svetkey L, Adams M, Oddone EZ. Take Control of Your Blood Pressure (TCYB) study: a multifactorial tailored behavioral and educational intervention for achieving blood pressure control. Patient Educ Couns. 2008 Mar;70(3):338-47. doi: 10.1016/j.pec.2007.11.014. Epub 2007 Dec 31.
Results Reference
result
PubMed Identifier
19920269
Citation
Bosworth HB, Olsen MK, Grubber JM, Neary AM, Orr MM, Powers BJ, Adams MB, Svetkey LP, Reed SD, Li Y, Dolor RJ, Oddone EZ. Two self-management interventions to improve hypertension control: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):687-95. doi: 10.7326/0003-4819-151-10-200911170-00148.
Results Reference
derived
PubMed Identifier
23702951
Citation
Muir KW, Grubber J, Mruthyunjaya P, McCant F, Bosworth HB. Progression of diabetic retinopathy in the hypertension intervention nurse telemedicine study. JAMA Ophthalmol. 2013 Jul;131(7):957-8. doi: 10.1001/jamaophthalmol.2013.81. No abstract available.
Results Reference
derived

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Comparison of Two Programs to Improve Blood Pressure Treatment Adherence

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