Effectiveness of a Multifactorial Intervention on Frailty

Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Frail Elderly; Dependence
• Intervention / Treatment: Other: Multifactorial intervention

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Institut Català de la Salut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Multifactorial intervention on frailty dimensions
No Intervention: No intervention; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Short Physical performance battery at 3 and 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).	0,3,18 months
Change from Baseline in Muscle strength at 3 and 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.	0,3,18 months
Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 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	0,3,18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Falls during follow-up, at 18 months		18 months
Change from Baseline in Functional Capacity at 18 months	Barthel Index Lawton&Brody Index	18 months
Number of Participants Hospitalized during follow-up, at 18 months		18 months
Number of Participants Institutionalized during follow-up, at 18 months		18 months
Number of Participants included in Home Health care during follow-up, at 18 months		18 months

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation
• Collaborators: Carlos III Health Institute
• Investigators: Principal Investigator: Josep Maria segura, MD, Phd, Jordi Gol Foundation

Publications and helpful links

General Publications

• Romera L, Orfila F, Segura JM, Ramirez A, Moller M, Fabra ML, Lancho S, Bastida N, Foz G, Fabregat MA, Marti N, Cullell M, Martinez D, Gine M, Bistuer A, Cendros P, Perez 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Frail elderly
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: PI12/01503