| ID | Type | Description | Link |
|---|---|---|---|
| R01HL070713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Pfizer | INDUSTRY |
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The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse administered | Experimental | Nurse Administered Intervention: Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months. |
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| Nurse & BP monitor | Experimental | 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. |
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| Usual Care | No Intervention | Subjects received neither home BP monitor nor nurse phone intervention. | |
| Home BP Monitor | Experimental | Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse administered | Behavioral | Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| BP measurement | Measured at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with care | Measured at 6 and 24 months | |
| Risk associated with hypertension | Measured at 6 and 24 months | |
| Self reported adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hayden B. Bosworth | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15797147 | Background | 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. | |
| 16177452 | Background | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015924 | Blood Pressure Monitors |
| ID | Term |
|---|---|
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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| BP Monitor | Device | Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months. |
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| Measured at 6 and 24 months |
| Efficacy with treatment | Measured at 6 and 24 months |
| 16050862 | Background | 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. |
| 16045379 | Background | 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. |
| 15894959 | Background | 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. |
| 14677147 | Background | 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. |
| 18780175 | Background | 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. |
| 18288540 | Background | 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. |
| 18401226 | Background | 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. |
| 19424920 | Background | 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. |
| 19920964 | Background | 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. |
| 19927132 | Background | 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. |
| 20694185 | Background | 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. |
| 16996808 | Result | 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. |
| 18164894 | Result | 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. |
| 23702951 | Derived | 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. |
| 19920269 | Derived | 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. |