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Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design
BACKGROUND: Frailty is a highly prevalent condition in old age leading to vulnerability and greater risk of adverse health outcomes and disability. Detecting and tackling frailty at an early stage can prevent disability. The purpose of this study is to evaluate the effectiveness of a multifactorial...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4258273/ https://www.ncbi.nlm.nih.gov/pubmed/25427568 http://dx.doi.org/10.1186/1471-2318-14-125 |
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author | Romera, Laura Orfila, Francesc Segura, Josep Maria Ramirez, Anna Möller, Mercedes Fabra, Maria Lluïsa Lancho, Santiago Bastida, Núria Foz, Gonçal Fabregat, Maria Assumpta Martí, Núria Cullell, Montserrat Martinez, Dolors Giné, Maria Bistuer, Anna Cendrós, Patricia Pérez, Elena |
author_facet | Romera, Laura Orfila, Francesc Segura, Josep Maria Ramirez, Anna Möller, Mercedes Fabra, Maria Lluïsa Lancho, Santiago Bastida, Núria Foz, Gonçal Fabregat, Maria Assumpta Martí, Núria Cullell, Montserrat Martinez, Dolors Giné, Maria Bistuer, Anna Cendrós, Patricia Pérez, Elena |
author_sort | Romera, Laura |
collection | PubMed |
description | BACKGROUND: Frailty is a highly prevalent condition in old age leading to vulnerability and greater risk of adverse health outcomes and disability. Detecting and tackling frailty at an early stage can prevent disability. The purpose of this study is to evaluate the effectiveness of a multifactorial intervention program to modify frailty parameters, muscle strength, and physical and cognitive performance in people aged 65 years or more. It also assesses changes from baseline in falls, hospitalizations, nutritional risk, disability, institutionalization, and home-care. METHODS/DESIGN: The current study is a randomised single-blind, parallel-group clinical trial, with a one and a half year follow-up, conducted in eight Primary Health Care Centres located in the city of Barcelona. Inclusion criteria are to be aged 65 years or older with positive frailty screening, timed get-up-and-go test between 10 to 30 seconds, and Cognition Mini-Exam (MEC-35) of Lobo greater than or equal to 18. A total of 352 patients have been equally divided into two groups: intervention and control. Sample size calculated to detect a 0.5 unit difference in the Short Physical Performance Battery (Common SD: 1.42, 20% lost to follow-up). In the intervention group three different actions on frailty dimensions: rehabilitative therapy plus intake of hyperproteic nutritional shakes, memory workshop, and medication review are applied to sets of 16 patients. Participants in both intervention and control groups receive recommendations on nutrition, healthy lifestyles, and home risks. Evaluations are blinded and conducted at 0, 3, and 18 months. Intention to treat analyses will be performed. Multivariate analysis will be carried out to assess time changes of dependent variables. DISCUSSION: It is expected that this study will provide evidence of the effectiveness of a multidisciplinary intervention on delaying the progression from frailty to disability in the elderly. It will help improve the individual’s quality of life and also reduce the rates of falls, hospital admissions, and institutionalizations, thus making the health care system more efficient. This preventive intervention can be adapted to diverse settings and be routinely included in Primary Care Centres as a Preventive Health Programme. TRIAL REGISTRATION: ClinicalTrials.gov PRS:NCT01969526. Date of registration: 10/21/2013. |
format | Online Article Text |
id | pubmed-4258273 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42582732014-12-08 Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design Romera, Laura Orfila, Francesc Segura, Josep Maria Ramirez, Anna Möller, Mercedes Fabra, Maria Lluïsa Lancho, Santiago Bastida, Núria Foz, Gonçal Fabregat, Maria Assumpta Martí, Núria Cullell, Montserrat Martinez, Dolors Giné, Maria Bistuer, Anna Cendrós, Patricia Pérez, Elena BMC Geriatr Study Protocol BACKGROUND: Frailty is a highly prevalent condition in old age leading to vulnerability and greater risk of adverse health outcomes and disability. Detecting and tackling frailty at an early stage can prevent disability. The purpose of this study is to evaluate the effectiveness of a multifactorial intervention program to modify frailty parameters, muscle strength, and physical and cognitive performance in people aged 65 years or more. It also assesses changes from baseline in falls, hospitalizations, nutritional risk, disability, institutionalization, and home-care. METHODS/DESIGN: The current study is a randomised single-blind, parallel-group clinical trial, with a one and a half year follow-up, conducted in eight Primary Health Care Centres located in the city of Barcelona. Inclusion criteria are to be aged 65 years or older with positive frailty screening, timed get-up-and-go test between 10 to 30 seconds, and Cognition Mini-Exam (MEC-35) of Lobo greater than or equal to 18. A total of 352 patients have been equally divided into two groups: intervention and control. Sample size calculated to detect a 0.5 unit difference in the Short Physical Performance Battery (Common SD: 1.42, 20% lost to follow-up). In the intervention group three different actions on frailty dimensions: rehabilitative therapy plus intake of hyperproteic nutritional shakes, memory workshop, and medication review are applied to sets of 16 patients. Participants in both intervention and control groups receive recommendations on nutrition, healthy lifestyles, and home risks. Evaluations are blinded and conducted at 0, 3, and 18 months. Intention to treat analyses will be performed. Multivariate analysis will be carried out to assess time changes of dependent variables. DISCUSSION: It is expected that this study will provide evidence of the effectiveness of a multidisciplinary intervention on delaying the progression from frailty to disability in the elderly. It will help improve the individual’s quality of life and also reduce the rates of falls, hospital admissions, and institutionalizations, thus making the health care system more efficient. This preventive intervention can be adapted to diverse settings and be routinely included in Primary Care Centres as a Preventive Health Programme. TRIAL REGISTRATION: ClinicalTrials.gov PRS:NCT01969526. Date of registration: 10/21/2013. BioMed Central 2014-11-27 /pmc/articles/PMC4258273/ /pubmed/25427568 http://dx.doi.org/10.1186/1471-2318-14-125 Text en © Romera et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Romera, Laura Orfila, Francesc Segura, Josep Maria Ramirez, Anna Möller, Mercedes Fabra, Maria Lluïsa Lancho, Santiago Bastida, Núria Foz, Gonçal Fabregat, Maria Assumpta Martí, Núria Cullell, Montserrat Martinez, Dolors Giné, Maria Bistuer, Anna Cendrós, Patricia Pérez, Elena Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design |
title | Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design |
title_full | Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design |
title_fullStr | Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design |
title_full_unstemmed | Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design |
title_short | Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design |
title_sort | effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4258273/ https://www.ncbi.nlm.nih.gov/pubmed/25427568 http://dx.doi.org/10.1186/1471-2318-14-125 |
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