Self-monitoring and self-titration of antihypertensive medication reduces systolic blood pressure compared with usual care

2015 ◽  
Vol 18 (3) ◽  
pp. 87-87 ◽  
Author(s):  
Hayden B Bosworth ◽  
Matthew J Crowley
BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022930 ◽  
Author(s):  
James P Sheppard ◽  
Jenni Burt ◽  
Mark Lown ◽  
Eleanor Temple ◽  
John Benson ◽  
...  

IntroductionRecent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multimorbidity. However, there is a lack of evidence to support deprescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up.Methods and analysisThis trial will use a primary care-based, open-label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mm Hg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, comorbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12-week follow-up (defined as a systolic blood pressure <150 mm Hg), which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long-term effects of any observed changes in blood pressure and quality of life.Ethics and disseminationThe protocol, informed consent form, participant information sheet and all other participant facing material have been approved by the Research Ethics Committee (South Central—Oxford A; ref 16/SC/0628), Medicines and Healthcare products Regulatory Agency (ref 21584/0371/001–0001), host institution(s) and Health Research Authority. All research outputs will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberEudraCT 2016-004236-38;ISRCTN97503221; Pre-results.


BMJ ◽  
2021 ◽  
pp. m4858
Author(s):  
Richard J McManus ◽  
Paul Little ◽  
Beth Stuart ◽  
Katherine Morton ◽  
James Raftery ◽  
...  

Abstract Objective The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. Design Unmasked randomised controlled trial with automated ascertainment of primary endpoint. Setting 76 general practices in the United Kingdom. Participants 622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet. Interventions Participants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines. Main outcome measures The primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values. Results After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of −3.4 mm Hg (95% confidence interval −6.1 to −0.8 mm Hg) and a mean difference in diastolic blood pressure of −0.5 mm Hg (−1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction. Conclusions The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded. Trial registration ISRCTN13790648 .


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Liping Chen ◽  
Yiyan Zhang ◽  
Juan Jin ◽  
Nannan Li ◽  
Dan Liu ◽  
...  

Objective. To explore the proportion and characteristic of Chinese adults meeting The Systolic Blood Pressure Intervention Trial (SPRINT) eligibility criteria and assess its generalizability. Method. Our study was based on a cross-sectional, population-based survey with a sample of 26,093 participants aged over 20 years. The SPRINT eligibility criteria were age ≥ 50 years, elevated SBP of 130 to 180 mmHg depending on the number of antihypertensive medication classes being taken, and increased cardiovascular disease (CVD) but without diabetes, history of stroke and estimated glomerular filtration rate < 20   ml / min / 1.73   m 2 , or receiving dialysis. Results. Overall, we estimated that 4,036 (15.5%) participants would meet the SPRINT eligibility criteria. They were generally older, likely to be female, lower educational level, tended to be more overweight, and had higher Framingham risk score compared with overall population or subjects aged ≥ 50 years. Of participants eligible for SPRINT, most (56.2%) of them were not treated for hypertension, and 542 (13.4%) were not previously considered to have hypertension or need for antihypertension therapy. Among the 11,637 adults with hypertension, 3,494 (30.0%) would potentially benefit from treatment intensification. The most common antihypertensive medication class being taken was diuretic agents. Conclusion. A substantial percentage of Chinese subjects meet the SPRINT eligibility criteria. Further studies are needed to assess the cost-effectiveness from treatment intensification in Chinese setting.


2020 ◽  
pp. 204748732095717
Author(s):  
Sebastiaan Blok ◽  
Eva L van der Linden ◽  
G Aernout Somsen ◽  
Igor I Tulevski ◽  
Michiel M Winter ◽  
...  

Background eHealth programs can lower blood pressure but also drive healthcare costs. This study aims to review the evidence on the effectiveness and costs of eHealth for hypertension and assess commonalities in programs with high effect and low additional cost. Results Overall, the incremental decrease in systolic blood pressure using eHealth, compared to usual care, was 3.87 (95% confidence interval (CI) 2.98–4.77) mmHg at 6 months and 5.68 (95% CI 4.77–6.59) mmHg at 12 months’ follow-up. High intensity interventions were more effective, resulting in a 2.6 (95% CI 0.5–4.7) (at 6 months) and 3.3 (95% CI 1.4–5.1) (at 12 months) lower systolic blood pressure, but were also more costly, resulting in €170 (95% CI 56–284) higher costs at 6 months and €342 (95% CI 128–556) at 12 months. Programs that included a high volume of participants showed €203 (95% CI 99–307) less costs than those with a low volume at 6 months, and €525 (95% CI 299–751) at 12 months without showing a difference in systolic blood pressure. Studies that implemented eHealth as a partial replacement, rather than addition to usual care, were also less costly (€119 (95% CI –38–201 at 6 months) and €346 (95% CI 261–430 at 12 months)) without being less effective. Evidence on eHealth programs for hypertension is ambiguous, heterogeneity on effectiveness and costs is high ( I2 = 56–98%). Conclusion Effective eHealth with limited additional costs should focus on high intensity interventions, involve a large number of participants and use eHealth as a partial replacement for usual care.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Dorien Lanssens ◽  
◽  
Inge M. Thijs ◽  
Wilfried Gyselaers

Abstract Background Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results. Methods After providing written consent, 3922 pregnant women aged ≥18 years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge–Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients’ electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcare-related costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires. Discussion To our knowledge, this is the first randomized trial comparing midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management among women at increased risk of GHD. Positive results of this study may lead to a practical framework for caregivers, hospital management, and payers to introduce RM into the prenatal care programs of high-risk pregnancies. Trial registration This study was registered on clinicaltrials.gov, identification number NCT04031430. Registered 24 July 2019, https://clinicaltrials.gov/ct2/show/NCT04031430?cond=premom+ii&draw=2&rank=1.


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