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MID-FRAIL-STUDY Report Summary

Project ID: 278803
Funded under: FP7-HEALTH
Country: Spain


Project Context and Objectives:
Diabetes is a high prevalence disorder with a chronic disease time-course. The prevalence in people ≥ 65 years approaches 20%, while at least 50% of all patients with diabetes are older than 65 years. It is anticipated that by 2050, the number of cases of diabetes will increase 4-fold in patients older than 70 years. Diabetes results in a high personal and social health burden, and a significant public health burden in terms of rising healthcare costs; in one EU country alone (Spain), annual direct healthcare costs were estimated to be 2.5 billion €.
Diabetes is associated with increased frailty and functional decline in older people and may explain up to 20% of the excess risk of disability in an elderly population, with an annual relative risk of developing any disability around 2.0. In recent studies involving older people, up to 28% of those with diabetes require some help with activities of daily living (compared with 16% in those without diabetes) and this functional decline can only be explained in half of the cases by the classical complications of the disease. This worsening in functional status, added to increased medical co-morbidities/overmedication associated with diabetes, results in many older frail people becoming more disabled and exhibiting an impaired quality of life associated with rising healthcare resources.
The MID-FRAIL-STUDY project focuses on the use of interventions designed to improve functional status and enhance quality of life rather than traditional treatments such as glucose- and blood pressure- lowering by acting on the mechanisms involved in producing frailty and its progression to adverse outcomes. This is justified for several reasons: first, there has been a marked lack of intervention studies in older people with diabetes; second, current clinical guidelines appear to be of limited utility in these patients; third, improvements in function and well-being may be fundamentally of more clinical benefit in older frail patients with diabetes than attention to metabolic control alone. These facts coupled with increasing concerns over the detrimental effects of aggressive glucose lowering in type 2 diabetes (T2D) provide a significant platform for addressing non-metabolic control areas to improve clinical outcomes. The severity of the long-term impact of diabetes in an aging population in terms of excessive health care expenditure serves to further support the value that may derive from this project.

Main objective:
To evaluate the effectiveness of a multi-modal intervention in frail and pre-frail subjects aged ≥ 70 years with T2D in terms of function and quality of life in comparison with usual clinical practice.
Secondary objectives:
a) To evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention in any of the following: (1) Economic costs/healthcare expenditure due to diabetes; (2) Incidence rate of symptomatic hypoglycemia and hypoglycemic coma; (3) Incidence of hospital admission; (4) Incidence of permanent institutionalization, and (5) Carer burden.
b) To evaluate the mechanisms underlying the effects of the intervention: (1) Studying the changes in the body composition with exercise (SARTRAIN SubStudy) and the effect of increased power in both isometric and dynamic actions (MID-POW SubStudy); and (2) Studying the role of metabolome (MetaboFrail SubStudy) and of genetic polymorphisms (GeneFrail SubStudy) as determinants of the response to treatment.
c) To evaluate the efficacy of new therapeutic devices (SENSOLES SubStudy) and new ways to measure changes in QoL (QoLFrail SubStudy).

Project Results:
During these months (36-48 months) the main objective for the study has been to coordinate the operationalization phase to can recruit the subjects and follow the study to can get the aim. In some cases, the Ethics committees have delayed the approval so, in this period we have obtained some approvals and the site activation has been delayed. Some these Ethics Committees have suggested changes. Meanwhile, the sites have been completing all the documentation and requirement to be activated.
The changes in the protocol and different documents have led to different versions of documents and amendments to the ethics committees.
Regarding the sub-studies, the Sensole II have been started. Genefrail, Metabofrail, Sartrain and Midpow have started and some amendments to the first version have been submitted to the Ethics Committees. Sensole I finished in the previous reporting period and results have been published.
A plan of pharmacovigilance has been followed to can establish the safety profile of the study and periodic reports have been sent to the Ethics Committees. Monitoring activities have been continued in trial sites.
Different Investigators’ meetings have taken place in the different countries by teleconference to activate them and follow the recruitment. In addition, several teleconferences among partners and coordinator in different countries have taken place to improve the recruitment.
First subject was included at 20 Dec 2013 in Spain. The last participant has been recruited in UK in the las 29th February 2016. All countries finished the recruitment period in 31th January 2016 except UK that continued recruiting until 29th February 2016.
During this period of time, all countries have been started and the recruitment has progressed in a good way.

Potential Impact:
The MID-FRAIL-STUDY is an innovative clinical trial that may produce the first objective evidence the utility of a multimodal intervention in ageing subjects with type 2 diabetes and features of frailty. The focus of the study is centred on clinical outcomes measured by functional assessment and an enquiry into quality of life dimensions. MID-FRAIL-STUDY aims to evaluate the effectiveness and efficiency of a multimodal intervention (therapeutic targets adapted to this population, exercise program and diabetes educational program including nutritional program) in elderly frail and prefrail patients with type II diabetes.
The information derived from the MIDFrail Study will enrich the evidence base for studies in diabetic subjects of advanced age, provide meaningful messages about what type of interventions are suitable for older people to undertake with a high degree of confidence and safety, and lead to recommendations in diabetes guidelines that can be implemented widely across the EU and globe.
A number of key benefits to the health status and well being of European ageing citizens is expected if the anticipated findings the MIDFrail Study are implemented across the European Union: these are related to significant numbers of older people with diabetes which we have previously calculated to be equivalent to nearly 700,000 fewer cases of disability per year in the EU. A consequence of the reduction in disability levels will be huge savings in social and healthcare expenditure which we have previously calculated to 3 billion euros per year, thus enabling the opportunity to re-invest some of these savings into more sustainable integrated healthcare systems for older people in general and in those with diabetes in particular. We anticipate a greater opportunity to establish networks of support across the EU of groups that have a significant interest in gerontological research who will want to work with the present consortium to develop new initiatives in the area of ageing, frailty and diabetes.
The MIDFrail study is the first of its kind in the world that has targeted a vulnerable and often neglected group of patients and as such the data will be unique and original. It has already brought together a consortium of academics, SMEs and not for profit research organisations, clinical scientists, pharmacologists and health economists that have a major interest in the applied research of older people which provides a tremendous platform for other future EU-wide research initiatives.
Some of the most relevant expected impacts of the project are listed below:
(a) Healthy ageing improvement at a European level: Diabetes is one of the leading long-term conditions associated with disability in old people in Europe, with significant personal and social consequences. The number of old people with diabetes in Europe is 20.7 millions. Around 50% of them are frail/prefrail, with an annual risk of 30 % to develop some disability. The project aims to demonstrate a reduction of 20% in that risk, which will mean a prevention of around 700,000 incident cases of some disability in old people per year. This is especially true in older women, where the prevalence of disability is near twice that in men and where particular disabilities in diabetes may be more common, i.e. falls and fractures.
(b) Significant impact on Healthcare cost reduction: The project will evaluate the economic impact of both the intervention and its potential effects, validating econometric models. The implementation of programs as being evaluated in this project could mean savings in the order of 3,000 million euros / year in the EU, thus contributing to the sustainability of health care systems and social protection.
(c) Active participation of research-intensive SMEs and patient advocacy groups and support networks: Three research-intensive SMEs play a leading role in this project, both in quantitative and (mainly) in qualitative terms.
(d) Coordination with on-going relevant European initiatives in the field: From the project’s inception, the consortium members are analysing all the relevant existing research initiatives in order to coordinate efforts and take advantage of the results already reached in European countries.
In summary, this project stems from a research line focused in the prevention of disability in old people with a preferential attention to the groups of higher risk: frail or pre-frail groups, which matches perfectly the EC objectives on Health and particularly on aging and diabetes.

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