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.
Detailed Description: Subjects enrolled in the main study will also be invited to join the following sub-studies: GENEFRAIL: this sub-study aims to determine the polymorphisms of several genes associated to frailty, in order to establish its predictive value for developing disability and response to treatment as well METABOFRAIL: this sub-study aims to investigate the metabolomic profile of frail and pre-frail patients. SARTRAIN: the combination of the assessment tools used in SARTRAIN (ARFI US, MRI, posturographic measurements) will provide a comprehensive study of the structural and functional characteristics of muscle and adjacent tissues and their change with time and the intervention. MID- POW: this sub-study aims to investigate changes in muscle power. The project also include an randomized controlled ancillary study: SENSOLE for which the aim is to investigate the potential effects of vibrating insoles device on gait and posture.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
986
Hospital Universitario de Getafe
Madrid, Getafe, Spain
Changes in summary ordinal score on the Short Physical Performance Battery test
The Short Physical Performance Battery (SPPB) is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines 3 areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. These areas represent essential tasks important for independent living and are thus an important outcome measure for patients with cardiovascular and pulmonary disease.
Time frame: 2 years
Lawton Instrumental Activity of Daily Living (IADL) scale
Time frame: 2 years
Barthel index of activities of daily living
Time frame: 2 years
Euro-Quality of Life (QoL) index
Time frame: 2 years
Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life,
Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life, using an economic model embracing the direct health-related costs (in-patient, out-patient, pharmaceutical, etc), formal care costs (home care, respite care, day centers, etc) and the informal care costs (carer).
Time frame: 2 years
Symptomatic hypoglycaemia
Episodes of symptomatic hypoglycaemia (i.e., a recorded blood sugar less than 4 mmol/L, or symptoms or signs attributed to low blood sugar and responding to appropriate treatment)
Time frame: 2 years
Hospital admissions
Episodes of hospital admission (i.e., any admission involving an overnight stay)
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Time frame: 2 years
Episodes of permanent institutionalization
Episodes of permanent institutionalization (i.e., permanent move to any care setting other than the patient's own home, where paid staff are available to provide care if needed at any time during the day or night).
Time frame: 2 years
Caregiver Strain Index
Burden of the carer, as assessed by the modified Caregiver Strain Index
Time frame: 2 years
Mortality
Time frame: 2 years