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Original Investigation |

Effect of Self-monitoring and Medication Self-titration on Systolic Blood Pressure in Hypertensive Patients at High Risk of Cardiovascular Disease:  The TASMIN-SR Randomized Clinical Trial

Richard J. McManus, FRCGP1; Jonathan Mant, MD2; M. Sayeed Haque, PhD3; Emma P. Bray, PhD4; Stirling Bryan, PhD5,6; Sheila M. Greenfield, PhD3; Miren I. Jones, PhD3; Sue Jowett, PhD7; Paul Little, MD8; Cristina Penaloza, MA7; Claire Schwartz, PhD1; Helen Shackleford, RGN3; Claire Shovelton, PhD3; Jinu Varghese, RGN3; Bryan Williams, MD9; F.D. Richard Hobbs, FMedSci1
[+] Author Affiliations
1National Institute for Health Research (NIHR) School for Primary Care Research, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
2Primary Care Unit, Strangeways Research Laboratory, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom
3Primary Care Clinical Sciences, NIHR School for Primary Care Research, University of Birmingham, Birmingham, Edgbaston, Birmingham, United Kingdom
4School of Psychology, University of Central Lancashire, Preston, Lancashire, United Kingdom
5Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada
6School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada
7Health Economics Unit, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom
8School of Medicine, University of Southampton, Southampton, United Kingdom
9Institute of Cardiovascular Sciences, NIHR University College London Hospitals Biomedical Research Centre, University College London, London, United Kingdom
JAMA. 2014;312(8):799-808. doi:10.1001/jama.2014.10057.
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Importance  Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups.

Objective  To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease.

Design, Setting, and Patients  A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013.

Interventions  Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary.

Main Outcomes and Measures  The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit.

Results  Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events.

Conclusions and Relevance  Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months.

Trial Registration  isrctn.org Identifier: ISRCTN87171227

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Figure 1.
Flow Through the Targets and Self-Management for the Control of Blood Pressure in Stroke and High-Risk Groups (TASMIN-SR) Trial

aThe breakdown of reasons for exclusion is not known.

bPatients gave more than 1 answer.

cTwo hundred thirty-nine of 243 patients in the control group attended the 6-month follow-up visit. Three were unable to be contacted and 1 had a serious illness in the family. Two hundred twenty-one of 226 patients in the intervention group attended the 6-month follow-up. Two were unable to attend due to illness and 1 had moved out of the area.

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Figure 2.
Blood Pressure Difference at 12 Months by Subgroup for Systolic Blood Pressure

aThe difference in blood pressure between groups at 12 months accounts for baseline blood pressure.

bIMD indicates the index of multiple deprivation. Higher values correspond to worse deprivation.

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