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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

Leocadio Rodríguez-Mañas1, Antony J Bayer3, Mark Kelly4, Andrej Zeyfang5, Mikel Izquierdo6, Olga Laosa2, Timothy C Hardman7, Alan J Sinclair8* and on behalf of the MID-Frail Consortium

Author Affiliations

1 Division of Geriatrics, Hospital Universitario de Getafe, Carretera de Toledo Km 12.5, 28905, Getafe, Spain

2 Fundación para la Investigación Biomédica, Hospital Universitario de Getafe, Carretera de Toledo Km 12.5 28905, Getafe, Spain

3 Institute of Primary Care and Public Health, School of Medicine, Cardiff University and Memory Team, Cardiff and Vale University Health Board, Cardiff CF14 4YS, UK

4 Institute of Translation, Innovation, Methodology and Engagement (TIME), South East Wales Trials Unit, School of Medicine, Cardiff University, Cardiff CF14 4XN, UK

5 University of Ulm, Institue of Epidemiology, Albert-Einstein-Allee 41, 89081 Ulm, Germany

6 Department of Health Sciences, Public University of Navarre, Campus of Tudela 31500 Tudela, Spain

7 Niche Science & Technology, Unit 26, Falstaff House, Bardolph Road, Richmond, TW9 2LH, UK

8 Institute of Diabetes for Older People (IDOP), University of Bedfordshire, Putteridge Bury Campus, Hitchin Road, Luton, Bedfordshire LU2 8LE, UK

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Trials 2014, 15:34  doi:10.1186/1745-6215-15-34

Published: 24 January 2014

Abstract

Background

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.

Keywords:
Multi-modal intervention; Frail; Pre-frail; Type 2 diabetes