Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes (MID-Frail)
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|ClinicalTrials.gov Identifier: NCT01654341|
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : March 26, 2019
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|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|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 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 ]
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|Ages Eligible for Study:||70 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Responsible Party:||Hospital Universitario Getafe|
|Other Study ID Numbers:||
278803-2 ( Other Identifier: European Commission: CORDIS: Seventh Framework Programme (FP7) )
|First Posted:||July 31, 2012 Key Record Dates|
|Last Update Posted:||March 26, 2019|
|Last Verified:||March 2019|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases