Effectiveness of a Multifactorial Intervention on Frailty

NCT01969526 | Completed

• 1 other identifier: PI12/01503
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly; Cognitive Impairment; Dependence

Keywords

Frail elderly

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of Participants with Falls during follow-up, at 18 months

  18 months

• Change from Baseline in Functional Capacity at 18 months

  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

Study Arms (2)

Multifactorial Intervention

EXPERIMENTAL

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

No intervention

NO INTERVENTION

Usual care

Interventions

Multifactorial intervention OTHER

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.

Also known as: Multifactorial intervention on frailty dimensions

Multifactorial Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Home Care
• Institutionalization
• Conditions not allowing physical exercise

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Institut Català de la Salut

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 25427568 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Josep Maria segura, MD, Phd

  Jordi Gol Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: October 25, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: September 30, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-03

Locations

ES (1)