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Randomized Controlled Trial
. 2014 May;38(1):145-54.
doi: 10.1016/j.cct.2014.04.006. Epub 2014 Apr 24.

The Multidomain Intervention to preveNt disability in ElDers (MINDED) project: rationale and study design of a pilot study

Affiliations
Randomized Controlled Trial

The Multidomain Intervention to preveNt disability in ElDers (MINDED) project: rationale and study design of a pilot study

Matteo Cesari et al. Contemp Clin Trials. 2014 May.

Abstract

Disability is hardly reversible at old age, negatively impacts on the elders' quality of life, and significantly threatens the sustainability of public health services. Therefore, preventive interventions become necessary for successfully avoiding its onset. The translation of the successful clinical approach represented by the geriatric comprehensive assessment at the community-level and the specific targeting of frailty (a well-established geriatric syndrome) might represent a promising possibility. This approach may allow the implementation of preventive interventions before the irreversible features of disability onset. Unfortunately, there is a lack of evidence on the effectiveness of primary prevention programs against disability in community-dwelling elders. Moreover, the novelty of the topic makes it difficult for the immediate design and conduction of a full-scale trial. For these reasons, a pilot project aimed at obtaining the preliminary information for the design of a subsequent definitive trial is required. In the present article, we describe the objectives, design, and methods of the Multidomain Intervention to preveNt Disability in ElDers (MINDED) project. MINDED is articulated into three sequential phases. First, a screening tool for indentifying non-disabled frail older persons in the community (ideal target population for preventive interventions against disability) will be validated. Then, the organization of a multidisciplinary team in the development and design of a multidomain preventive plan against disability will be verified/optimized. Finally, a randomized controlled trial measuring the effect size of a multicomponent intervention (based on physical exercise, nutrition, and cognitive training) against incident mobility disability versus usual care in community-dwelling frail elders will be conducted.

Keywords: Clinical practice; Cognition; Community; Comprehensive geriatric assessment; Disability; Elderly; Frailty; Nutrition; Physical exercise; Physical performance; Pilot study; Primary prevention; Randomized controlled trial; Validation.

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