An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial

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dc.contributor.authorRodríguez Mañas, Leocadio
dc.contributor.authorBayer, Antony J.
dc.contributor.authorKelly, Mark
dc.contributor.authorZeyfang, Andrej
dc.contributor.authorIzquierdo Redín, Mikel
dc.contributor.authorLaosa, Olga
dc.contributor.authorHardman, Timothy C.
dc.contributor.authorSinclair, Alan J.
dc.contributor.departmentCiencias de la Saludes_ES
dc.contributor.departmentOsasun Zientziakeu
dc.date.accessioned2015-10-27T08:36:36Z
dc.date.available2015-10-27T08:36:36Z
dc.date.issued2014
dc.descriptionIncluye 2 ficheros de datoses_ES
dc.description.abstractBackground: Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. Methods/Design: The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. Discussion: The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. Trial registration: ClinicalTrials.gov: NCT01654341.en
dc.description.sponsorshipThis study was funded by the European Commission Seventh Framework Programme.en
dc.format.mimetypeapplication/pdfen
dc.format.mimetypeapplication/zipen
dc.identifier.doi10.1186/1745-6215-15-34
dc.identifier.issn1745-6215
dc.identifier.urihttps://academica-e.unavarra.es/handle/2454/18637
dc.language.isoengen
dc.publisherBioMed Centralen
dc.relation.ispartofTrials 2014, 15:34en
dc.relation.publisherversionhttps://dx.doi.org/10.1186/1745-6215-15-34
dc.rights© 2014 Rodríguez-Mañas et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by/2.0/
dc.rights.urihttp://creativecommons.org/publicdomain/zero/1.0/
dc.subjectMulti-modal interventionen
dc.subjectFrailen
dc.subjectPre-frailen
dc.subjectType 2 diabetesen
dc.titleAn evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trialen
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
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relation.isAuthorOfPublication.latestForDiscoveryef73585d-4750-4f56-9d4f-0d759232dbca

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