Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Exercise, dietary and educational program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participant is willing and able to give written informed consent for participation in the study. Subjects aged 70 years or older, with a diagnosis of type 2 diabetes mellitus for at least 2 years. Require to fulfill Fried ́s criteria for frail or pre-frail individuals. Exclusion criteria: Barthel score lower than 60 points. Inability to carry out SPPB test (total score=0). Mini Mental State Examination score less than 20 points. Subjects unwilling or unable to consent or unable to participate safely in intervention program. Previous history of myocardial infarction within 6 months, unstable angina or congestive heart failure in III-IV NYHA stage. Clinically instable patients in the clinical judgment of the investigator. Terminal illness (life expectancy < 6 months). Any other condition that, in the clinical judgment of the investigator, means that it would not in the patient's best interests to enter the study. Current participation in clinical trial or any other investigational study.

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>Subjects undergo usual standard of care | |
| Experimental: Intervention Group<br>Intervention with exercise, dietary and educational programs | Behavioral: Exercise, dietary and educational program<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lawton Instrumental Activity of Daily Living (IADL) scale |  | 2 years | 
| Barthel index of activities of daily living |  | 2 years | 
| Euro-Quality of Life (QoL) index |  | 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). | 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) | 2 years | 
| Hospital admissions | Episodes of hospital admission (i.e., any admission involving an overnight stay) | 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). | 2 years | 
| Caregiver Strain Index | Burden of the carer, as assessed by the modified Caregiver Strain Index | 2 years | 
| Mortality |  | 2 years |