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dc.contributor.authorFarmer, AJen
dc.contributor.authorOke, Jen
dc.contributor.authorHardeman, Wen
dc.contributor.authorTucker, Len
dc.contributor.authorSutton, Stephenen
dc.contributor.authorKinmonth, Ann-Louiseen
dc.contributor.authorGriffin, Simonen
dc.contributor.authorHolman, RRen
dc.date.accessioned2017-04-12T14:16:11Z
dc.date.available2017-04-12T14:16:11Z
dc.date.issued2016-10en
dc.identifier.issn0168-8227
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/263642
dc.description.abstractAIMS: Clinical trial patients are highly motivated but may encounter difficulty in taking study medication regularly when treatment burden is substantial. We assessed a brief behavioural intervention, given in addition to a standard trial protocol. METHODS: We performed a two-arm adherence sub-study within a twelve-month randomised controlled drug trial evaluating the impact of statin and/or omega-3 EE90 treatment in 800 patients with type 2 diabetes. Fifty-nine United Kingdom general practices were cluster-randomised to action-planning or control groups. The former delivered an initial written exercise prompting participants to formulate action-plans to take study medication regularly, with brief nurse encouragement to use action-plans at later visits, whilst the latter followed the standard trial protocol. The primary outcome was proportion of days on which study medication were taken as intended measured by electronic medication containers. RESULTS: Adjusted mean (95% CI) proportion of days with medication taken as intended was 79.3% (76.3-82.3%)for the 30 action-planning practices (321 participants), compared with 78.5% (75.8-81.1%) for 27 control group practices (426 participants, with a mean intervention effect of 0.9%, 95% CI -3.1% to +4.9%, p=0.67). Adjusted odds ratios for ⩾80% trial medication adherence for action-planning compared with control practices were 1.29 (0.90-1.84) and 1.38 (0.96-1.99) respectively. CONCLUSIONS: Low-intensity action-planning interventions used alone are unlikely to have a clinically important impact on medication adherence, particularly in a clinical trial setting. These findings, do not exclude their contribution, as part of a multifactorial intervention, to improving treatment adherence. ISRCTN number 76737502.
dc.description.sponsorshipPfizer Ltd.
dc.languageengen
dc.language.isoenen
dc.publisherElsevier BV
dc.subjectAction planningen
dc.subjectAdherenceen
dc.subjectAdultsen
dc.subjectOmega-3 EE90en
dc.subjectStatinen
dc.subjectType 2 diabetesen
dc.subjectAgeden
dc.subjectAtorvastatin Calciumen
dc.subjectBehavior Therapyen
dc.subjectCase-Control Studiesen
dc.subjectClinical Protocolsen
dc.subjectDiabetes Mellitus, Type 2en
dc.subjectDouble-Blind Methoden
dc.subjectEarly Intervention (Education)en
dc.subjectFemaleen
dc.subjectHealth Promotionen
dc.subjectHumansen
dc.subjectHydroxymethylglutaryl-CoA Reductase Inhibitorsen
dc.subjectMaleen
dc.subjectMedication Adherenceen
dc.subjectMiddle Ageden
dc.subjectMotivationen
dc.subjectRisk Reduction Behavioren
dc.subjectUnited Kingdomen
dc.titleThe effect of a brief action planning intervention on adherence to double-blind study medication, compared to a standard trial protocol, in the Atorvastatin in Factorial with Omega EE90 Risk Reduction in Diabetes (AFORRD) clinical trial: A cluster randomised sub-studyen
dc.typeArticle
prism.endingPage64
prism.publicationDate2016en
prism.publicationNameDiabetes Research and Clinical Practiceen
prism.startingPage56
prism.volume120en
dc.identifier.doi10.17863/CAM.9000
dcterms.dateAccepted2016-07-16en
rioxxterms.versionofrecord10.1016/j.diabres.2016.07.004en
rioxxterms.versionAMen
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2016-10en
dc.contributor.orcidSutton, Stephen [0000-0003-1610-0404]
dc.contributor.orcidGriffin, Simon [0000-0002-2157-4797]
dc.identifier.eissn1872-8227
rioxxterms.typeJournal Article/Reviewen
pubs.funder-project-idMRC (MC_UU_12015/4)
pubs.funder-project-idMedical Research Council (MC_U106179474)
cam.issuedOnline2016-07-30en
rioxxterms.freetoread.startdate2017-07-30


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