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Effectiveness of a Multifactorial Intervention on Frailty

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ClinicalTrials.gov Identifier: NCT01969526
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Tracking Information
First Submitted Date  ICMJE August 1, 2013
First Posted Date  ICMJE October 25, 2013
Last Update Posted Date November 13, 2017
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Change from Baseline in Short Physical performance battery at 3 and 18 months [ Time Frame: 0,3,18 months ]
    The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
  • Change from Baseline in Muscle strength at 3 and 18 months [ Time Frame: 0,3,18 months ]
    Evaluation of upper extremities strength was assessed through the measurement of force with a handgrip dynamometer. Grip strength was evaluated using a portable hand dynamometer (JAMAR®0-90 kg, coding 506320). The participants were seated with their shoulder in a neutral position and their elbow flexed at 90°. Three attempts were performed alternately in each hand; the mean of the three measures was recorded.
  • Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 18 months [ Time Frame: 0,3,18 months ]
    The first neuro-psychometric instrument developed in Spain to measure semi-quantitatively cognitive status in clinical neurology was the Barcelona Test (BT). Shortened version of the BT, named Barcelona Test Review (BTR) had been used for neuropsychological area evaluation in our participants and it takes only 20-30 minutes to administer
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Change from Baseline in Short Physical performance battery at 3,12 and 18 months [ Time Frame: 0,3,12,18 months ]
  • Change from Baseline in Timed Get Up and Go at 3,12 and 18 months [ Time Frame: 0,3,12,18 months ]
  • Change from Baseline in Muscle strength at 3,12 and 18 months [ Time Frame: 0,3,12,18 months ]
    Dynamometer
  • Change from Baseline in Cognitive Lobo test at 3,12 and 18 months [ Time Frame: 0,3,12,18 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Number of Participants with Falls during follow-up, at 18 months [ Time Frame: 18 months ]
  • Change from Baseline in Functional Capacity at 18 months [ Time Frame: 18 months ]
    Barthel Index Lawton&Brody Index
  • Number of Participants Hospitalized during follow-up, at 18 months [ Time Frame: 18 months ]
  • Number of Participants Institutionalized during follow-up, at 18 months [ Time Frame: 18 months ]
  • Number of Participants included in Home Health care during follow-up, at 18 months [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Number of Participants with Falls during follow-up, at 12 and 18 months [ Time Frame: 12,18 months ]
  • Change from Baseline in Functional Capacity at 12 and 18 months [ Time Frame: 12,18 months ]
    Barthel Index Lawton&Brody Index
  • Number of Participants Hospitalized during follow-up, at 12 and 18 months [ Time Frame: 12,18 months ]
  • Number of Participants Institutionalized during follow-up, at 12 and 18 months [ Time Frame: 12,18 months ]
  • Number of Participants included in Home Health care during follow-up, at 12 and 18 months [ Time Frame: 12,18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Multifactorial Intervention on Frailty
Official Title  ICMJE Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population
Brief Summary

Objective: To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Secondly, to assess changes in falls, hospitalizations, nutritional risk, disability and institutionalization or home-care.

Methods: randomized clinical trial with a control group, of one year and a half of follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group (difference to be detected on physical performance (Short physical performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).

Intervention: consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.

Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for repeated measures to adjust for differences attributable to intervention effect and for potential confounders such as comorbidity, sensory limitations, social risk, other medical or social interventions, among others.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Frail Elderly
  • Cognitive Impairment
  • Dependence
Intervention  ICMJE Other: Multifactorial intervention
Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy and physical exercise plus intake of hyperproteic shakes, memory workshop and review of the medication.
Other Name: Multifactorial intervention on frailty dimensions
Study Arms  ICMJE
  • Experimental: Multifactorial Intervention
    Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.
    Intervention: Other: Multifactorial intervention
  • No Intervention: No intervention
    Usual care
Publications * Romera L, Orfila F, Segura JM, Ramirez A, Möller M, Fabra ML, Lancho S, Bastida N, Foz G, Fabregat MA, Martí N, Cullell M, Martinez D, Giné M, Bistuer A, Cendrós P, Pérez E. Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design. BMC Geriatr. 2014 Nov 27;14:125. doi: 10.1186/1471-2318-14-125.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)
352
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
320
Actual Study Completion Date  ICMJE September 30, 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Positive Barber screen
  • Timed get-up-and-go 10 to 20 seconds
  • cognitive Lobo test greater than or equal to 18

Exclusion Criteria:

  • Home Care
  • Institutionalization
  • Conditions not allowing physical exercise
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01969526
Other Study ID Numbers  ICMJE PI12/01503
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jordi Gol i Gurina Foundation
Study Sponsor  ICMJE Jordi Gol i Gurina Foundation
Collaborators  ICMJE Carlos III Health Institute
Investigators  ICMJE
Principal Investigator: Josep Maria segura, MD, Phd Jordi Gol Foundation
PRS Account Jordi Gol i Gurina Foundation
Verification Date March 2017

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