Comparison of Two Programs to Improve Blood Pressure Treatment Adherence
Take Control of Your Blood Pressure (TCYB)
2 other identifiers
interventional
777
1 country
1
Brief Summary
The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Jun 2003
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 20, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedSeptember 8, 2014
September 1, 2014
2.5 years
July 20, 2005
September 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BP measurement
Measured at 6 months
Secondary Outcomes (4)
Satisfaction with care
Measured at 6 and 24 months
Risk associated with hypertension
Measured at 6 and 24 months
Self reported adherence
Measured at 6 and 24 months
Efficacy with treatment
Measured at 6 and 24 months
Study Arms (4)
Nurse administered
EXPERIMENTALNurse Administered Intervention: Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months.
Nurse & BP monitor
EXPERIMENTALSubjects 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.
Usual Care
NO INTERVENTIONSubjects received neither home BP monitor nor nurse phone intervention.
Home BP Monitor
EXPERIMENTALSubject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
Interventions
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Pfizercollaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27705, United States
Related Publications (17)
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.
PMID: 15797147BACKGROUNDHong 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.
PMID: 16177452BACKGROUNDKim 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.
PMID: 16050862BACKGROUNDHong 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.
PMID: 16045379BACKGROUNDBosworth 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.
PMID: 15894959BACKGROUNDBosworth 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.
PMID: 14677147BACKGROUNDTrivedi 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.
PMID: 18780175BACKGROUNDBosworth 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.
PMID: 18288540BACKGROUNDPowers 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.
PMID: 18401226BACKGROUNDAyotte 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.
PMID: 19424920BACKGROUNDVoils 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.
PMID: 19920964BACKGROUNDReed 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.
PMID: 19927132BACKGROUNDTrivedi 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.
PMID: 20694185BACKGROUNDBosworth 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.
PMID: 16996808RESULTBosworth 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.
PMID: 18164894RESULTMuir 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.
PMID: 23702951DERIVEDBosworth 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.
PMID: 19920269DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hayden B. Bosworth
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
June 1, 2003
Primary Completion
December 1, 2005
Study Completion
June 1, 2007
Last Updated
September 8, 2014
Record last verified: 2014-09