Abstract
BackgroundDiabetes, 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/DesignThe 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.DiscussionThe 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 registrationClinicalTrials.gov: NCT01654341.
Highlights
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
Diabetes has serious personal and social consequences, and is a significant public health burden in terms of rising health care costs; in Spain, annual direct health care costs have been estimated at 2.5 billion euros [4]
The worsening in functional status due to deterioration of skeletal muscle, increased co-morbidities, and adverse effects of overmedication associated with diabetes, results in many older frail people becoming more disabled, with an impaired quality of life associated with increased use of health care resources [6,7,8]
Summary
A highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. Diabetes is associated with increasing frailty and functional decline in older people [2]. In recent studies of older people, up to 28% of those with diabetes required some help with activities of daily living, compared with 16% of those without the condition [5]. This functional decline can be explained in only half of the cases by the classical complications of the disease, such as coronary artery disease, stroke, and peripheral vascular disease [5]. The worsening in functional status due to deterioration of skeletal muscle, increased co-morbidities, and adverse effects of overmedication associated with diabetes, results in many older frail people becoming more disabled, with an impaired quality of life associated with increased use of health care resources [6,7,8]
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