The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Frailty among older people is related to an increased risk of adverse health outcomes such as acute and chronic diseases, disability and mortality. Although many intervention studies for frail older people have been reported, only a...

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Main Authors: Metzelthin Silke F, van Rossum Erik, de Witte Luc P, Hendriks Marike RC, Kempen Gertrudis IJM
Format: Article
Language:English
Published: BMC 2010-08-01
Series:BMC Public Health
Online Access:http://www.biomedcentral.com/1471-2458/10/511
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spelling doaj-316f72ed60c646f99eb1b8e2a13be9162020-11-25T02:16:56ZengBMCBMC Public Health1471-24582010-08-0110151110.1186/1471-2458-10-511The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trialMetzelthin Silke Fvan Rossum Erikde Witte Luc PHendriks Marike RCKempen Gertrudis IJM<p>Abstract</p> <p>Background</p> <p>Frailty among older people is related to an increased risk of adverse health outcomes such as acute and chronic diseases, disability and mortality. Although many intervention studies for frail older people have been reported, only a few have shown positive effects regarding disability prevention. This article presents the design of a two-arm cluster randomized controlled trial on the effectiveness, cost-effectiveness and feasibility of a primary care intervention that combines the most promising elements of disability prevention in community-dwelling frail older people.</p> <p>Methods/design</p> <p>In this study twelve general practitioner practices were randomly allocated to the intervention group (6 practices) or to the control group (6 practices). Three thousand four hundred ninety-eight screening questionnaires including the Groningen Frailty Indicator (GFI) were sent out to identify frail older people. Based on their GFI score (≥5), 360 participants will be included in the study. The intervention will receive an interdisciplinary primary care intervention. After a comprehensive assessment by a practice nurse and additional assessments by other professionals, if needed, an individual action plan will be defined. The action plan is related to a flexible toolbox of interventions, which will be conducted by an interdisciplinary team. Effects of the intervention, both for the frail older people and their informal caregivers, will be measured after 6, 12 and 24 months using postal questionnaires and telephone interviews. Data for the process evaluation and economic evaluation will be gathered continuously over a 24-month period.</p> <p>Discussion</p> <p>The proposed study will provide information about the usefulness of an interdisciplinary primary care intervention. The postal screening procedure was conducted in two cycles between December 2009 and April 2010 and turned out to be a feasible method. The response rate was 79.7%. According to GFI scores 29.3% of the respondents can be considered as frail (GFI ≥ 5). Nearly half of them (48.1%) were willing to participate. The baseline measurements started in January 2010. In February 2010 the first older people were approached by the practice nurse for a comprehensive assessment. Data on the effect, process, and economic evaluation will be available in 2012.</p> <p>Trial Registration</p> <p>ISRCTN31954692</p> http://www.biomedcentral.com/1471-2458/10/511
collection DOAJ
language English
format Article
sources DOAJ
author Metzelthin Silke F
van Rossum Erik
de Witte Luc P
Hendriks Marike RC
Kempen Gertrudis IJM
spellingShingle Metzelthin Silke F
van Rossum Erik
de Witte Luc P
Hendriks Marike RC
Kempen Gertrudis IJM
The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial
BMC Public Health
author_facet Metzelthin Silke F
van Rossum Erik
de Witte Luc P
Hendriks Marike RC
Kempen Gertrudis IJM
author_sort Metzelthin Silke F
title The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial
title_short The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial
title_full The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial
title_fullStr The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial
title_full_unstemmed The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial
title_sort reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial
publisher BMC
series BMC Public Health
issn 1471-2458
publishDate 2010-08-01
description <p>Abstract</p> <p>Background</p> <p>Frailty among older people is related to an increased risk of adverse health outcomes such as acute and chronic diseases, disability and mortality. Although many intervention studies for frail older people have been reported, only a few have shown positive effects regarding disability prevention. This article presents the design of a two-arm cluster randomized controlled trial on the effectiveness, cost-effectiveness and feasibility of a primary care intervention that combines the most promising elements of disability prevention in community-dwelling frail older people.</p> <p>Methods/design</p> <p>In this study twelve general practitioner practices were randomly allocated to the intervention group (6 practices) or to the control group (6 practices). Three thousand four hundred ninety-eight screening questionnaires including the Groningen Frailty Indicator (GFI) were sent out to identify frail older people. Based on their GFI score (≥5), 360 participants will be included in the study. The intervention will receive an interdisciplinary primary care intervention. After a comprehensive assessment by a practice nurse and additional assessments by other professionals, if needed, an individual action plan will be defined. The action plan is related to a flexible toolbox of interventions, which will be conducted by an interdisciplinary team. Effects of the intervention, both for the frail older people and their informal caregivers, will be measured after 6, 12 and 24 months using postal questionnaires and telephone interviews. Data for the process evaluation and economic evaluation will be gathered continuously over a 24-month period.</p> <p>Discussion</p> <p>The proposed study will provide information about the usefulness of an interdisciplinary primary care intervention. The postal screening procedure was conducted in two cycles between December 2009 and April 2010 and turned out to be a feasible method. The response rate was 79.7%. According to GFI scores 29.3% of the respondents can be considered as frail (GFI ≥ 5). Nearly half of them (48.1%) were willing to participate. The baseline measurements started in January 2010. In February 2010 the first older people were approached by the practice nurse for a comprehensive assessment. Data on the effect, process, and economic evaluation will be available in 2012.</p> <p>Trial Registration</p> <p>ISRCTN31954692</p>
url http://www.biomedcentral.com/1471-2458/10/511
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