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OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial.

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cam.issuedOnline2018-10-04
dc.contributor.authorSheppard, James P
dc.contributor.authorBurt, Jenni
dc.contributor.authorLown, Mark
dc.contributor.authorTemple, Eleanor
dc.contributor.authorBenson, John
dc.contributor.authorFord, Gary A
dc.contributor.authorHeneghan, Carl
dc.contributor.authorHobbs, FD Richard
dc.contributor.authorJowett, Sue
dc.contributor.authorLittle, Paul
dc.contributor.authorMant, Jonathan
dc.contributor.authorMollison, Jill
dc.contributor.authorNickless, Alecia
dc.contributor.authorOgburn, Emma
dc.contributor.authorPayne, Rupert
dc.contributor.authorWilliams, Marney
dc.contributor.authorYu, Ly-Mee
dc.contributor.authorMcManus, Richard J
dc.contributor.orcidSheppard, James P [0000-0002-4461-8756]
dc.contributor.orcidBurt, Jenni [0000-0002-0037-274X]
dc.contributor.orcidHeneghan, Carl [0000-0002-1009-1992]
dc.contributor.orcidYu, Ly-Mee [0000-0003-0331-7364]
dc.contributor.orcidMcManus, Richard J [0000-0003-3638-028X]
dc.date.accessioned2018-11-16T00:30:29Z
dc.date.available2018-11-16T00:30:29Z
dc.date.issued2018-10-04
dc.description.abstractINTRODUCTION: Recent 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 ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: EudraCT 2016-004236-38; ISRCTN97503221; Pre-results.
dc.format.mediumElectronic
dc.identifier.doi10.17863/CAM.32492
dc.identifier.eissn2044-6055
dc.identifier.issn2044-6055
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/285121
dc.languageeng
dc.language.isoeng
dc.publisherBMJ
dc.publisher.urlhttp://dx.doi.org/10.1136/bmjopen-2018-022930
dc.rightsAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectantihypertensive
dc.subjectcardiovascular disease
dc.subjectde-prescribing
dc.subjectfrailty
dc.subjectmulti-morbidity
dc.subjectAged
dc.subjectBlood Pressure Determination
dc.subjectDeprescriptions
dc.subjectFemale
dc.subjectHumans
dc.subjectHypertension
dc.subjectMale
dc.subjectMultimorbidity
dc.subjectOutcome and Process Assessment, Health Care
dc.subjectPatient Care Management
dc.subjectPolypharmacy
dc.subjectPrimary Health Care
dc.subjectQuality of Life
dc.subjectSeverity of Illness Index
dc.subjectRandomized Controlled Trials as Topic
dc.titleOPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial.
dc.typeArticle
dcterms.dateAccepted2018-08-18
prism.issueIdentifier9
prism.publicationDate2018
prism.publicationNameBMJ Open
prism.startingPagee022930
prism.volume8
pubs.funder-project-idNational Institute for Health Research (NIHR) (via University of Oxford) (335)
rioxxterms.licenseref.startdate2018-10-04
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.typeJournal Article/Review
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1136/bmjopen-2018-022930

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