Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 October 2014 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
Universiteit Gent
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: October 30, 2014
Last verified: October 2014

July 27, 2012
October 30, 2014
December 2013
March 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01654341 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Lawton IADL scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Barthel ADL index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Euro-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 ]
Not Provided
Not Provided
 
Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Type 2 Diabetes Mellitus
Behavioral: Exercise, dietary and educational program
  • No Intervention: Usual Care Group
    Subjects undergo usual standard of care
  • Experimental: Intervention Group
    Intervention with exercise, dietary and educational programs
    Intervention: Behavioral: Exercise, dietary and educational program
Rodríguez-Mañas L, Bayer AJ, Kelly M, Zeyfang A, Izquierdo M, Laosa O, Hardman TC, Sinclair AJ, Moreira S, Cook J; MID-Frail Consortium. An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial. Trials. 2014 Jan 24;15:34. doi: 10.1186/1745-6215-15-34.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1718
March 2017
March 2017   (final data collection date for primary outcome measure)

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.
Both
70 Years and older
No
Contact: Leocadio Rodríguez Mañas, MD 00 34 916839360 ext 6412 lrodriguez.hugf@salud.madrid.org
Contact: Belén Riquelme briquelme.hugf@salud.madrid.org
Spain
 
NCT01654341
MID-Frail, 278803-2
No
Hospital Universitario Getafe
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
  • Universiteit Gent
  • University of Castilla-La Mancha
  • Univerzita Karlova v Praze
  • Niche Science & Technology Ltd
  • Catholic University of the Sacred Heart
  • Vrije Universiteit Brussel
Principal Investigator: Leocadio Rodríguez Mañas, MD Hospital Universitario de Getafe
Hospital Universitario Getafe
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP