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dc.contributor.authorFarmer, Andrew Jen
dc.contributor.authorPrevost, Tobyen
dc.contributor.authorHardeman, Wendyen
dc.contributor.authorCraven, Antheaen
dc.contributor.authorSutton, Stephenen
dc.contributor.authorGriffin, Simonen
dc.contributor.authorKinmonth, Ann-Louiseen
dc.contributor.authorSupport, and Advice for Medication Study SAMSen
dc.date.accessioned2011-06-16T16:28:56Z
dc.date.available2011-06-16T16:28:56Z
dc.date.issued2008-04-11en
dc.identifier.issn1471-2296
dc.identifier.urihttp://www.dspace.cam.ac.uk/handle/1810/237976
dc.description.abstractAbstract Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study) trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation is carried out independently of trial co-ordination and practices using minimisation to adjust for selected confounders. Discussion The SAMS intervention and trial design address weaknesses of previous research by recruitment from a well-characterised population, definition of a feasible theory based intervention to support medication taking and careful measurement to estimate and interpret efficacy. The results will inform practice and the design of a cost-effectiveness trial [ISRCTN30522359].
dc.languageEnglishen
dc.language.isoen
dc.titleProtocol for SAMS (Support and Advice for Medication Study): a randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medicationen
dc.typeArticle
dc.date.updated2011-06-16T16:28:56Z
dc.description.versionRIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are.en
dc.rights.holderFarmer et al.; licensee BioMed Central Ltd.
prism.publicationDate2008en
dcterms.dateAccepted2008-04-11en
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2008-04-11en
dc.contributor.orcidSutton, Stephen [0000-0003-1610-0404]
dc.contributor.orcidGriffin, Simon [0000-0002-2157-4797]
dc.identifier.eissn1471-2296
rioxxterms.typeJournal Article/Reviewen
pubs.funder-project-idMRC (G0200391)
pubs.funder-project-idMRC (MC_UU_12015/4)
pubs.funder-project-idMedical Research Council (MC_U106179474)
pubs.funder-project-idMRC (G0500267)


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