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  • Periodic Report Summary 1 - MID-FRAIL-STUDY (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)
FP7

MID-FRAIL-STUDY Sintesi della relazione

Project ID: 278803
Finanziato nell'ambito di: FP7-HEALTH
Paese: Spain

Periodic Report Summary 1 - MID-FRAIL-STUDY (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)


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.

OBJECTIVES

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 first 18 months of the project, the MID-Frail partners have undergone some significant challenges. The MID-Frail study is progressing at a satisfactory pace, and significant achievements have been made during this period:

The design of the global clinical trial protocol of the project has been completed. The protocols of the substudies GENEFRAIL, METABOFRAIL and SARTRAIN were finished on February 2013, and the protocol for the SENSOLE substudy was completed on March 2013. The exercise program has been defined; the educational and nutritional programs have been designed, as well as the safety and surveillance strategies. The external advisory Committee has already been designated. The EAC, responsible for progress, safety, efficacy endpoints, and recommendations to the Sponsor on whether to continue, modify or stop, it is composed of scientists in geriatrics, diabetes and clinical research, and it will meet at least 3 times along the study.

An Investigators’ meeting for all trial sites sited in Spain took place on June 2013 at the SERMAS facilities in the Hospital Universitario de Getafe in Madrid. In the meeting, it was explained in detail the exercise program described in the study protocol and a demonstration with the machines that will be used was made, as well as a brief presentation on the practicalities surrounding each of the sub-studies and on the data collection and the electronic case report form (eCRF). Currently, the Spanish team is working hard to finalise all contracts with the study sites so that recruitment of subjects can be initiated soon.

The MID-Frail study is also making good progress in the United Kingdom in both England and Wales. Another Investigators’ meeting was held at the Institute of Diabetes for Older People (IDOP) on June 2013, updating the information focused on (1) the nutritional component of the study, (2) the exercises to be performed by the study participants and demonstration of the equipment; (3) data collection methods and eCRF and (4) the logistics surrounding the ordering, delivery and assembly of study equipment.

The site selection has already been completed in Belgium, the Czech Republic, Germany, Italy, France-Bordeaux and the United Kingdom- England. Site selection is on-going in France- Toulouse and United Kingdom-Wales. Spain is leading the way with all trial sites selected and ethics approval being confirmed for every site.

Two Clinical Research Organisations (CROs) will manage the submission of study documentation in all countries other than Spain. There is a CRO for the Czech Republic and other CRO for Belgium, France, Germany, Italy and the United Kingdom. The contracts with both of them are already signed. The translation of essential documents into local languages is complete and the documents were sent to the study partners who took on the responsibility of reviewing them.

The insurance for the project and for the substudies has been signed for all the countries involved.

Potential Impact:

MID-FRAIL-STUDY is a clinical trial that 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 1,718 elderly frail and prefrail patients with type II diabetes.

The 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.

Among the innovations and contributions include:

(1) This is the first clinical trial of diabetes in the elderly. One of the main problems when make clinical recommendations for the treatment of elderly patients with diabetes, is the total lack of evidence to support these recommendations. From the results of this project will derive recommendations that may change the clinical practice in this population, which represents 50% of all subjects with diabetes.
(2) Interventions are adapted to characteristics of patients. The exercise program will focus on resistance training that can be practiced by all the elders, unlike aerobic exercise that could only be done by those who maintain good physical shape. Diabetes education and nutrition are focused in the prevention and identification of hypoglycaemia situations and prevent malnutrition.
(3) Outcomes are associated with the maintenance of functional autonomy and preventing the development of incident disability and impaired quality of life.

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, eg. 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.

List of Websites:

www.midfrail-study.org


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