Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes (MID-Frail)
|ClinicalTrials.gov Identifier: NCT01654341|
Recruitment Status : Unknown
Verified February 2016 by Hospital Universitario Getafe.
Recruitment status was: Active, not recruiting
First Posted : July 31, 2012
Last Update Posted : March 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Exercise, dietary and educational program||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||986 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
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|
- Changes in summary ordinal score on the Short Physical Performance Battery test [ Time Frame: 2 years ]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 ]
- 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, [ Time Frame: 2 years ]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 ]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 ]Episodes of hospital admission (i.e., any admission involving an overnight stay)
- Episodes of permanent institutionalization [ Time Frame: 2 years ]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 ]Burden of the carer, as assessed by the modified Caregiver Strain Index
- Mortality [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654341
|Hospital Universitario de Getafe|
|Madrid, Getafe, Spain, 28905|
|Principal Investigator:||Leocadio Rodríguez Mañas, MD||Hospital Universitario de Getafe|