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A RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF A MULTI-MODAL INTERVENTION IN OLDER PEOPLE WITH TYPE 2 DIABETES ON FRAILTY AND QUALITY OF LIFE: THE MID-FRAIL STUDY (MidFrail)

This study is not yet open for participant recruitment.
Verified February 2012 by Spanish Clinical Research Network - CAIBER
Sponsor:
Collaborators:
Hospital Universitario Getafe
European Commission
Information provided by (Responsible Party):
Spanish Clinical Research Network - CAIBER
ClinicalTrials.gov Identifier:
NCT01541787
First received: February 24, 2012
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

The study will be an open randomized clinical trial, carried out by investigators in several countries of the European Union with random allocation by clusters (Trial sites-TS) to Usual Care Group (UCG) or Intervention Group (IG). The randomization unit will be the cluster (needed as the education and the exercise programs will be done in groups and to avoid or control contamination bias). Every trial site (TS) will have a mean average size of 14-15 patients each. Every national Research centre (RC) will be in charge of 11-12 TS. Patients will be followed for 24 months, and reviewed at least twice a year.


Condition Intervention
OLDER PEOPLE WITH TYPE 2 DIABETES
 Behavioral: education and the exercise programs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OPEN CLUSTER RANDOMIZED CLINICAL TRIAL, PHASE IIB TO EVALUATE THE EFFECTIVENESS OF A MULTI-MODAL INTERVENTION IN OLDER PEOPLE WITH TYPE 2 DIABETES ON FRAILTY AND QUALITY OF LIFE

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spanish Clinical Research Network - CAIBER:

Primary Outcome Measures:
  • effectiveness of a multi-modal intervention [ Time Frame: Follow up of the resuts in the 12 months patients follow up ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of a multi-modal intervention in frail and pre-frail subjects aged ≥ 70 years with T2D in terms of function and quality of life in comparison with usual clinical practice


Secondary Outcome Measures:
  • Economic costs/healthcare expenditure due to diabetes [ Time Frame: Follow up during the 12 months patient follow up the out come will be analyzed in M42 from the initiation of the study ] [ Designated as safety issue: No ]
    To evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention in terms of Economic costs/healthcare expenditure due to diabetes


Estimated Enrollment: 1704
Study Start Date: June 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care Group (UCG)
Centers with standar treatment (with no modification from the usual Care)
Intervention Group (IG)
Education and the exercise programs implementation in the interventional sites
 Behavioral: education and the exercise programs
education exercise programs

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 70 years or older, with a diagnosis of T2D for at least 2 years,
  • Require to fulfill Fried criteria for frail or pre-frail individuals (Fried L, et al., 2001). See table 2.

Exclusion Criteria:

  • Barthel score lower than 60 points
  • Inability to carry out SPPB test (Guralnik J et al., 1995)
  • Mini mental State Examination score less than 20 points
  • Subjects unwilling or unable to consent or unable to participate in intervention program
  • Previous history of myocardial infarction within 6 months, unstable angina or congestive heart failure in III-IV NYHA stage
  • Terminal illness (life expectancy < 6 months)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541787

Contacts
Contact: Maria Sanchiz 0034918222488 msanchiz@caiber.net
Contact: Rocio Arce 0034918222422 rarce@caiber.net

Locations
Spain
Hospital Universitario de Getafe Not yet recruiting
Madrid, Spain, 28002
Contact: Leocaldio Rodriguez, PhD         lrodriguez.hugf@salud.madrid.org    
Principal Investigator: Leocadio Rodriguez, PhD            
Sponsors and Collaborators
Spanish Clinical Research Network - CAIBER
Hospital Universitario Getafe
European Commission
  More Information

No publications provided

Responsible Party: Spanish Clinical Research Network - CAIBER
ClinicalTrials.gov Identifier: NCT01541787     History of Changes
Other Study ID Numbers: MID-FRAIL
Study First Received: February 24, 2012
Last Updated: February 29, 2012
Health Authority: Belgium: Ethics Committee
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Committee for the Protection of Personnes
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Spanish Clinical Research Network - CAIBER:
Frai Prefrail older diabetes

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

ClinicalTrials.gov processed this record on May 21, 2013