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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Hospital Universitario Getafe
Sponsor:
Collaborators:
Institute of Diabetes for Older People
Cardiff University
Igen Biotech SL
Chu Hopitaux de Bordeaux
Hexabio Sarl
Second University of Naples
University Hospital, Toulouse
Universitaet Ulm
University Ghent
University of Castilla-La Mancha
Univerzita Karlova v Praze
Niche Science & Technology Ltd
Catholic University of the Sacred Heart
Vrije Universiteit Brussel
Information provided by (Responsible Party):
Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01654341
First received: July 27, 2012
Last updated: May 19, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Exercise, dietary and educational program

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1718
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)
Arms Assigned Interventions
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: this sub-study aims to assess changes in one of the muscles of the thigh according to time and MID-Frail randomisation MID-POW: this sub-study aims to investigate changes in muscle power

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654341

Contacts
Contact: Leocadio Rodríguez Mañas, MD 00 34 916839360 ext 6412 lrodriguez.hugf@salud.madrid.org
Contact: Belén Riquelme briquelme.hugf@salud.madrid.org

Locations
Spain
Hospital Universitario de Getafe Recruiting
Madrid, Getafe, Spain, 28905
Contact: Leocadio Rodríguez Mañas, MD    00 34 916839360 ext 6512    lrodriguez.hugf@salud.madrid.org   
Principal Investigator: Leocadio Rodríguez Mañas, MD         
Sponsors and Collaborators
Hospital Universitario Getafe
Institute of Diabetes for Older People
Cardiff University
Igen Biotech SL
Chu Hopitaux de Bordeaux
Hexabio Sarl
Second University of Naples
University Hospital, Toulouse
Universitaet Ulm
University Ghent
University of Castilla-La Mancha
Univerzita Karlova v Praze
Niche Science & Technology Ltd
Catholic University of the Sacred Heart
Vrije Universiteit Brussel
Investigators
Principal Investigator: Leocadio Rodríguez Mañas, MD Hospital Universitario de Getafe
  More Information

No publications provided by Hospital Universitario Getafe

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01654341     History of Changes
Obsolete Identifiers: NCT01541787
Other Study ID Numbers: MID-Frail, 278803-2
Study First Received: July 27, 2012
Last Updated: May 19, 2015
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 30, 2015