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Effectiveness of a Multifactorial Intervention on Frailty

Primary Purpose

Frail Elderly, Cognitive Impairment, Dependence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multifactorial intervention
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frail Elderly focused on measuring Frail elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Català de la Salut

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifactorial Intervention

No intervention

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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).
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.
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

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2013
Last Updated
November 8, 2017
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Carlos III Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01969526
Brief Title
Effectiveness of a Multifactorial Intervention on Frailty
Official Title
Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Carlos III Health Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly, Cognitive Impairment, Dependence
Keywords
Frail elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifactorial Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Multifactorial intervention
Other Intervention Name(s)
Multifactorial intervention on frailty dimensions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Short Physical performance battery at 3 and 18 months
Description
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).
Time Frame
0,3,18 months
Title
Change from Baseline in Muscle strength at 3 and 18 months
Description
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.
Time Frame
0,3,18 months
Title
Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 18 months
Description
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
Time Frame
0,3,18 months
Secondary Outcome Measure Information:
Title
Number of Participants with Falls during follow-up, at 18 months
Time Frame
18 months
Title
Change from Baseline in Functional Capacity at 18 months
Description
Barthel Index Lawton&Brody Index
Time Frame
18 months
Title
Number of Participants Hospitalized during follow-up, at 18 months
Time Frame
18 months
Title
Number of Participants Institutionalized during follow-up, at 18 months
Time Frame
18 months
Title
Number of Participants included in Home Health care during follow-up, at 18 months
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Maria segura, MD, Phd
Organizational Affiliation
Jordi Gol Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Català de la Salut
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25427568
Citation
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.
Results Reference
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Effectiveness of a Multifactorial Intervention on Frailty

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