Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes (MID-Frail)
Type 2 Diabetes Mellitus
Behavioral: Exercise, dietary and educational program
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Changes in summary ordinal score on the Short Physical Performance Battery test [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Lawton Instrumental Activity of Daily Living (IADL) scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Barthel index of activities of daily living [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Euro-Quality of Life (QoL) index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life, [ Time Frame: 2 years ] [ Designated as safety issue: No ]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).
- Symptomatic hypoglycaemia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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)
- Hospital admissions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Episodes of hospital admission (i.e., any admission involving an overnight stay)
- Episodes of permanent institutionalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]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).
- Caregiver Strain Index [ Time Frame: 2 years ] [ Designated as safety issue: No ]Burden of the carer, as assessed by the modified Caregiver Strain Index
- Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care Group
Subjects undergo usual standard of care
Experimental: Intervention Group
Intervention with exercise, dietary and educational programs
|Behavioral: Exercise, dietary and educational program|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654341
|Hospital Universitario de Getafe|
|Madrid, Getafe, Spain, 28905|
|Principal Investigator:||Leocadio Rodríguez Mañas, MD||Hospital Universitario de Getafe|