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Content archived on 2024-06-18

A RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF A MULTI-MODAL INTERVENTION IN OLDER PEOPLE WITH TYPE 2 DIABETES ON FRAILTY AND QUALITY OF LIFE: THE MID-FRAIL STUDY

Objective

The prevalence of diabetes in people ≥ 65 years approaches 25% (40% of all patients with diabetes are > 65 years). This number will increase 4-fold in people > 70 years in 2050. Diabetes results in a high personal and social health burden, and a significant public health burden in terms of rising healthcare costs. Diabetes is associated with increased functional decline in older people and may explain up to 20% of their excess risk of disability. Our project focuses on the use of interventions to improve functional status and enhance quality of life. This is justified because there has been a lack of intervention studies in this population and improvements in function and well-being may be of more clinical benefit in older patients than attention to metabolic control alone.
The MID-FRAIL STUDY is a Phase IIb open randomized clinical trial to evaluate the effectiveness of a multi-modal intervention (optimizing medical management, resistance-based exercise program and educational/nutritional intervention) in 1,704 frail or pre-frail subjects ≥ 70 years with T2D to prevent functional decline and maintain or improve quality of life and its associated costs.
This approach is original (both the intervention and outcomes are unique for studies in diabetes), relevant (it concerns 25% of people with diabetes), pertinent and feasible.
The project is highly aligned with objectives pursued by two topics of this call: investigator-driven clinical trials in elderly populations (HEALTH 2011 2.2.2-1) and in diabetes complications (HEALTH.2011.2.4.3-1).
The study aims to demonstrate a reduction of 20% in that risk, which will mean an annual prevention of around 700,000 incident cases of some disability in old people, with a major impact on global quality of life and financial costs. This is especially true in older women. Three research-intensive SMEs will play a leading role in this project and it also has the support of Diabetes UK, a major patient and family advocacy organisation

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Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

FP7-HEALTH-2011-two-stage
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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

CP-FP - Small or medium-scale focused research project

Coordinator

SERVICIO MADRILENO DE SALUD
EU contribution
€ 1 347 893,88
Address
Paseo De la Castellana, 280
28046 MADRID
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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Participants (16)

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