Two Self-management Interventions to Improve Hypertension Control
A Randomized Trial
- Hayden B. Bosworth, PhD;
- Maren K. Olsen, PhD;
- Janet M. Grubber, MSPH;
- Alice M. Neary, RN;
- Melinda M. Orr, MEd;
- Benjamin J. Powers, MD;
- Martha B. Adams, MD;
- Laura P. Svetkey, MD;
- Shelby D. Reed, PhD;
- Yanhong Li, MS;
- Rowena J. Dolor, MD, MHS; and
- Eugene Z. Oddone, MD, MHS
- From the Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center; Duke University; Center for Aging and Human Development, Duke University; Duke Hypertension Center, Duke University; and Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Abstract
Background: Fewer than 40% of persons with hypertension in the United States have adequate blood pressure (BP) control.
Objective: To compare 2 self-management interventions for improving BP control among hypertensive patients.
Design: A 2 × 2 randomized trial, stratified by enrollment site and patient health literacy status, with 2-year follow-up. (ClinicalTrials.gov registration number: NCT00123058)
Setting: 2 university-affiliated primary care clinics.
Patients: 636 hypertensive patients.
Intervention: A centralized blinded and stratified randomization algorithm was used to randomly assign eligible patients to receive usual care, a behavioral intervention (bimonthly tailored nurse-administered telephone intervention targeting hypertension-related behaviors), home BP monitoring 3 times weekly, or the behavioral intervention plus home BP monitoring.
Measurements: The primary outcome was BP control at 6-month intervals over 24 months. 475 patients (75%) completed the 24-month BP follow-up.
Results: At 24 months, improvements in the proportion of patients with BP control relative to the usual care group were 4.3% (95% CI, −4.5% to 12.9%) in the behavioral intervention group, 7.6% (CI, −1.9% to 17.0%) in the home BP monitoring group, and 11.0% (CI, 1.9%, 19.8%) in the combined intervention group. Relative to usual care, the 24-month difference in systolic BP was 0.6 mm Hg (CI, −2.2 to 3.4) for the behavioral intervention group, −0.6 mm Hg (CI, −3.6 to 2.3) for the BP monitoring group, and −3.9 mm Hg (CI, −6.9 to −0.9) for the combined intervention group; patterns were similar patterns were for diastolic BP.
Limitation: Generalizability is limited because changes in medication use and diet were monitored only in intervention participants; 24-month outcome data were missing for 25% of participants, BP control was adequate at baseline in 73% of participants, and the study setting was an academic health center.
Conclusion: Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and diastolic BP at 24 months relative to usual care.
Primary Funding Source: National Heart, Lung, and Blood Institute; Pfizer Foundation Health Communication Initiative; and the American Heart Association.
Article and Author Information
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Disclaimer: The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.
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Grant Support: By grant R01 HL070713 from the National Heart, Lung, and Blood Institute, a Pfizer Foundation Health Communication Initiative Award, and an Established Investigator Award from the American Heart Association (Dr. Bosworth).
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Potential Financial Conflicts of Interest: None disclosed.
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Reproducible Research Statement: Study protocol and data set: Available from Dr. Bosworth (e-mail, hayden.bosworth{at}duke.edu). Statistical code: Available from Dr. Olsen (e-mail, maren.olsen{at}duke.edu).
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Requests for Single Reprints: Hayden B. Bosworth, PhD, Center for Health Services Research in Primary Care, Duke University, 2424 Erwin Road, Hock Plaza, Durham, NC 27703; e-mail, hayden.bosworth{at}duke.edu.
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Current author addresses and author contributions are available at www.annals.org.
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Current Author Addresses: Drs. Bosworth and Powers and Ms. Neary: Center for Health Services Research in Primary Care, Duke University, 2424 Erwin Road, Hock Plaza, Durham, NC 27703.
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Drs. Olsen and Oddone, Ms. Grubber, and Ms. Orr: Durham Veterans Affairs Medical Center (152), 508 Fulton St. Durham NC 27705.
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Dr. Adams: Duke University Medical Center, Box 3230, Durham, NC 27710.
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Dr. Svetkey: Duke Hypertension Center, Sarah W. Stedman Nutrition and Metabolism Center 3475 Erwin Road, Suite 100, Durham, NC 27705.
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Dr. Reed, Ms. Li, and Ms. Dolor: Duke Clinical Research Institute, 2400 Pratt Street, Room 311, Durham, NC 27705.
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Author Contributions: Conception and design: H.B. Bosworth, M.K. Olsen, M.M. Orr, M.B. Adams, L.P. Svetkey, E.Z. Oddone.
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Analysis and interpretation of the data: H.B. Bosworth, M.K. Olsen, J.M. Grubber, L.P. Svetkey, S.D. Reed, Y. Li, E.Z. Oddone.
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Drafting of the article: H.B. Bosworth, M.K. Olsen, J.M. Grubber, A.M. Neary, M.M. Orr, E.Z. Oddone.
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Critical revision of the article for important intellectual content: H.B. Bosworth, M.K. Olsen, A.M. Neary, B.J. Powers, M.B. Adams, L.P. Svetkey, S.D. Reed, R.J. Dolor, E.Z. Oddone.
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Final approval of the article: H.B. Bosworth, M.K. Olsen, M.M. Orr, L.P. Svetkey, S.D. Reed, Y. Li, R.J. Dolor, E.Z. Oddone.
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Provision of study materials or patients: A.M. Neary, B.J. Powers, L.P. Svetkey.
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Statistical expertise: H.B. Bosworth, M.K. Olsen, J.M. Grubber, Y. Li.
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Obtaining of funding: H.B. Bosworth, M.K. Olsen, E.Z. Oddone.
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Administrative, technical, or logistic support: H.B. Bosworth, M.M. Orr, M.B. Adams, R.J. Dolor, E.Z. Oddone.
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Collection and assembly of data: J.M. Grubber, A.M. Neary, M.M. Orr, Y. Li.
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