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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Exercise, dietary and educational program

Detailed Description

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
• Enrollment (Actual): 986
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Getafe
    • Madrid, Getafe, Spain, 28905
      • Hospital Universitario de Getafe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in summary ordinal score on the Short Physical Performance Battery test	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		2 years
Lawton Instrumental Activity of Daily Living (IADL) scale		2 years
Barthel index of activities of daily living		2 years
Euro-Quality of Life (QoL) index		2 years
Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life,	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).	2 years
Symptomatic hypoglycaemia	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)	2 years
Hospital admissions	Episodes of hospital admission (i.e., any admission involving an overnight stay)	2 years
Episodes of permanent institutionalization	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).	2 years
Caregiver Strain Index	Burden of the carer, as assessed by the modified Caregiver Strain Index	2 years

Collaborators and Investigators

• Sponsor: Hospital Universitario Getafe
• Collaborators: Cardiff University; Catholic University of the Sacred Heart; University Hospital, Bordeaux; University of Campania "Luigi Vanvitelli"; University Hospital, Toulouse; University Ghent; University of Ulm; Vrije Universiteit Brussel; University of Castilla-La Mancha; Diabetes Frail Ltd; Univerzita Karlova v Praze; Igen Biotech SL; Hexabio Sarl; Niche Science & Technology Ltd
• Investigators: Principal Investigator: Leocadio Rodríguez Mañas, MD, Hospital Universitario de Getafe

Publications and helpful links

General Publications

• Regueme SC, Cowtan C, Sedgelmaci MY, Kelson M, Poustis J, Rodriguez-Manas L, Sinclair AJ, Dallaudiere B, Bourdel-Marchasson I. A Therapeutic Insole Device for Postural Stability in Older People With Type 2 Diabetes. A Feasibility Study (SENSOLE Part I). Front Med (Lausanne). 2019 Jun 27;6:127. doi: 10.3389/fmed.2019.00127. eCollection 2019.
• Rodriguez-Manas 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): July 31, 2012

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: MID-Frail; 278803-2 (Other Identifier: European Commission: CORDIS: Seventh Framework Programme (FP7))