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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cardiff University
Igen Biotech SL
University Hospital, Bordeaux
Hexabio Sarl
Second University of Naples
University Hospital, Toulouse
University of 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
Diabetes Frail Ltd
Information provided by (Responsible Party):
Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01654341
First received: July 27, 2012
Last updated: March 22, 2016
Last verified: February 2016

July 27, 2012
March 22, 2016
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.

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.

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.
 
Active, not recruiting
986
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   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01654341
MID-Frail, 278803-2
No
Not Provided
Not Provided
Hospital Universitario Getafe
Hospital Universitario Getafe
  • Cardiff University
  • Igen Biotech SL
  • University Hospital, Bordeaux
  • Hexabio Sarl
  • Second University of Naples
  • University Hospital, Toulouse
  • University of 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
  • Diabetes Frail Ltd
Principal Investigator: Leocadio Rodríguez Mañas, MD Hospital Universitario de Getafe
Hospital Universitario Getafe
February 2016

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