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 (MidFrail)

This study is not yet open for participant recruitment.
Verified February 2012 by Spanish Clinical Research Network - CAIBER
Sponsor:
Collaborators:
Hospital Universitario Getafe
European Commission
Information provided by (Responsible Party):
Spanish Clinical Research Network - CAIBER
ClinicalTrials.gov Identifier:
NCT01541787
First received: February 24, 2012
Last updated: February 29, 2012
Last verified: February 2012

February 24, 2012
February 29, 2012
June 2012
February 2016   (final data collection date for primary outcome measure)
effectiveness of a multi-modal intervention [ Time Frame: Follow up of the resuts in the 12 months patients follow up ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01541787 on ClinicalTrials.gov Archive Site
Economic costs/healthcare expenditure due to diabetes [ Time Frame: Follow up during the 12 months patient follow up the out come will be analyzed in M42 from the initiation of the study ] [ Designated as safety issue: No ]
To evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention in terms of Economic costs/healthcare expenditure due to diabetes
Same as current
Not Provided
Not Provided
 
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
OPEN CLUSTER RANDOMIZED CLINICAL TRIAL, PHASE IIB TO EVALUATE THE EFFECTIVENESS OF A MULTI-MODAL INTERVENTION IN OLDER PEOPLE WITH TYPE 2 DIABETES ON FRAILTY AND QUALITY OF LIFE

The study will be an open randomized clinical trial, carried out by investigators in several countries of the European Union with random allocation by clusters (Trial sites-TS) to Usual Care Group (UCG) or Intervention Group (IG). The randomization unit will be the cluster (needed as the education and the exercise programs will be done in groups and to avoid or control contamination bias). Every trial site (TS) will have a mean average size of 14-15 patients each. Every national Research centre (RC) will be in charge of 11-12 TS. Patients will be followed for 24 months, and reviewed at least twice a year.

Exploring the impact of T2D on functional status and quality of life in frail/pre-frail aging citizens raises challenging issues of how to manage effectively patients with a limited life expectancy. Our initiative creates the opportunity to study different treatment aims than those often tailored for younger patients with diabetes. This approach is highly relevant in subgroups of pre-frail and frail older people, in which the risk of incident disability in a short time is increased (30% annually, Pahor M et al., 2006). Although older people represent the main proportion of people with diabetes (> 50%), most previous intervention studies have put their main (indeed, their unique) emphasis on younger populations (Volpato S et al 2010).These latter studies have usually centered around the prevention of cardiovascular disease usually by drug-treatment interventions designed to achieve stringent glucose targets. This approach can be exceedingly dangerous mainly in older patients with diabetes; for instance, recurrent hypoglycemia is associated with an increased risk of dementia (Whitmer RA et al., 2009) and falls (Mayne D, 2010).

Furthermore, the benefits of such treatments are not realized before at least ten years of continuous treatment, which may be beyond the life span of a patient with frailty. In elderly patients with T2D it is imperative to develop specific care plans (Paolisso G & Sinclair AJ, 2010), aimed to prevent and control for disability as the main target. Previous studies in the area of multidisciplinary working have been mainly observational in nature (AGS, 2003), and often outcomes measures had not been validated in aging subjects.

In addition, we will carry out a comparative analysis of the alternative courses of action in terms of their costs and their health outcomes, a relevant approach in diseases like T2D, a chronic condition, and especially in older populations, where the risk of disability and dependence is so high. A cost of illness study describes the economic burden of a disease from the payer or from the society perspective. So, a cost of illness study can complement epidemiology and clinical data, adding useful information about the economic dimension of a health problem, and providing data that are valuable to society and decision-makers with respect to the relative and absolute importance of the illness in question. However, from the point of view of efficiency, resources should not be allocated on the basis of the burden of a specific disease, but rather according to the greatest health benefits that can be obtained as a result of a given intervention. For this reason, jointly with the analysis of costs we will develop an economic evaluation, a comparative analysis, of the clinical alternative considered. In summary, despite the clinical, social and economic importance of functional change in older people with diabetes, no studies have previously evaluated the benefits of a multi-model (comprehensive) therapeutic approach in patients at high risk for disability (frail and pre-frail elders).

Beside these issues, this project will also try to establish the predictive value of the response to treatment of several polymorphisms that have been associated to frailty and some other disabling conditions (Pro259Arg-TCN2 gene, Matteini A et al., 2010; ACE I/D-ACE gene, Abadir PM 2011; and e2/e3/e4-Apo E gene, Kulminski A et al., 2008), disabled conditions ACE I/D-ACE gene, Seripa D et al., 2010) or muscle strength (ACE I/D-ACE gene, Giaccaglia V et al., 2008) and of some components of the metaboloma, as its association with some components of frailty in old patients with T2D. In this regard, sophisticated metabolomic analytical platforms and informatics tools have already been developed to study the metabolic phenotype of a patient at the global level through the analysis of the complete repertoire of small molecules present in cells, tissues or biofluids; this approach could provide: (1) prognostic, diagnostic, and surrogate markers for a disease state; (2) biomarkers for drug response phenotypes (pharmacometabolomics); (3) the characterization of metabolic changes elicited by various stimuli, including nutritional interventions and exercise and, (4) information about mechanisms of disease (Nicholson JK & Lindon JC, 2008; Holmes E et al., 2008; Lewis GD et al., 2010). Up to now, there has not been a comprehensive evaluation and mapping of global metabolic changes in frail/sarcopenic elderly patients with diabetes when a multimodal therapeutic approach is carried out.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
OLDER PEOPLE WITH TYPE 2 DIABETES
Behavioral: education and the exercise programs
education exercise programs
  • No Intervention: Usual Care Group (UCG)
    Centers with standar treatment (with no modification from the usual Care)
  • Intervention Group (IG)
    Education and the exercise programs implementation in the interventional sites
    Intervention: Behavioral: education and the exercise programs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1704
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged 70 years or older, with a diagnosis of T2D for at least 2 years,
  • Require to fulfill Fried criteria for frail or pre-frail individuals (Fried L, et al., 2001). See table 2.

Exclusion Criteria:

  • Barthel score lower than 60 points
  • Inability to carry out SPPB test (Guralnik J et al., 1995)
  • Mini mental State Examination score less than 20 points
  • Subjects unwilling or unable to consent or unable to participate in intervention program
  • Previous history of myocardial infarction within 6 months, unstable angina or congestive heart failure in III-IV NYHA stage
  • Terminal illness (life expectancy < 6 months)
Both
70 Years and older
No
Contact: Maria Sanchiz 0034918222488 msanchiz@caiber.net
Contact: Rocio Arce 0034918222422 rarce@caiber.net
Spain
 
NCT01541787
MID-FRAIL
Yes
Spanish Clinical Research Network - CAIBER
Spanish Clinical Research Network - CAIBER
  • Hospital Universitario Getafe
  • European Commission
Not Provided
Spanish Clinical Research Network - CAIBER
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP