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Open Access Study protocol

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

Silke F Metzelthin1*, Erik van Rossum123, Luc P de Witte134, Marike RC Hendriks5 and Gertrudis IJM Kempen1

Author Affiliations

1 Department of Health Care and Nursing Science, School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands

2 Centre of Research on Autonomy and Participation, Zuyd University of Applied Sciences, Heerlen, The Netherlands

3 Centre of Research on Technology in Care, Zuyd University of Applied Sciences, Heerlen, The Netherlands

4 Department of Social Medicine, School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands

5 Department of Human Movement Science, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands

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BMC Public Health 2010, 10:511  doi:10.1186/1471-2458-10-511

Published: 23 August 2010

Abstract

Background

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.

Methods/design

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.

Discussion

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.

Trial Registration

ISRCTN31954692