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ISRCTN
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ISRCTN43792817
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ClinicalTrials.gov identifier
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Public title
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Reduction of fear of falling and associated increase in functional ability, activity level and quality of life in community-living older adults who are at risk for falling: a randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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014-91-052
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Study hypothesis
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Fear of falling and associated activity restriction is common in older persons living in the community. Adverse consequences of fear of falling and associated activity restriction, like functional decline and falls, may have a major impact on physical, mental and social functioning of these persons. This paper presents the design of a trial evaluating a cognitive behavioural group intervention to reduce fear of falling and associated activity restriction in older persons living in the community.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Fear of falling in older adults in the community
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Participants - inclusion criteria
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Age 70 or older, living independently in the community, reporting fear of falling and associated activity restriction.
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Participants - exclusion criteria
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Confined to bed, restricted by permanent use of wheelchair, on waiting list for nursing home admission.
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Anticipated start date
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01/03/2002
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Anticipated end date
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31/03/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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540
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Interventions
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The intervention group receives a cognitive behavioural group intervention developed to reduce fear of falling and to promote physical, social, and functional activity. This intervention is derived from 'A Matter of Balance', which is developed and evaluated by Tennstedt and colleagues in Boston, US. The protocol is translated and adapted to the Dutch context. The intervention program consists of eight weekly group sessions of two hours and a booster session six months after the last session. The intervention aims to increase self-efficacy beliefs with regard to falling as well as the sense of control over falling.
The control group receives usual care, meaning they receive no intervention as a result of this trial.
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Primary outcome measure(s)
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Fear of falling and daily activity. Fear of falling is assessed by a single question "Are you afraid of falling?" (1= never to 5= always). Falls related self-efficacy is assessed by an adapted version of the Falls Efficacy Scale (FES). Daily activity is assessed by the Frenchay Activity Index (FAI). To assess activity restriction due to fear of falling a single question was incorporated in the questionnaire: "Do you avoid certain activities due to fear of falling?" (1= never to 5= always).
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Secondary outcome measure(s)
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Psychological, physical and social functioning. The Hospital Anxiety and Depression Scale (HADS) assessed psychological functioning. Physical functioning is assessed by the ADL subscale of the Groningen Activity Restriction Scale (GARS). Social functioning is assessed by a social support measure (SSL) and by a loneliness question.
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Sources of funding
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Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
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Trial website
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Publications
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2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15780139
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16139984
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Contact name
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Prof
G.I.J.M.
Kempen
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Address
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Universiteit Maastricht
Faculty of Health Sciences
Department of Health Care Studies
Section Medical Sociolgy
P.O. Box 616
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City/town
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Maastricht
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Zip/Postcode
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6200 MD
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Country
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Netherlands
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Tel
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+31 (0)43 3882204
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Fax
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+31 (0)43 3884169
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Email
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g.kempen@zw.unimaas.nl
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Sponsor
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Maastricht University, The Netherlands
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Address
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Faculty of Health Sciences and Care and Public Health Research Institute
P.O. Box 616
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City/town
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Maastricht
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Zip/Postcode
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6200 MD
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Country
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Netherlands
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Tel
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+31 (0)43 3881738
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Fax
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+31 (0)43 3670944
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Email
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voorlichting@facburfdgw.unimaas.nl
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Date applied
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07/10/2004
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Last edited
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01/09/2009
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Date ISRCTN assigned
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09/11/2004
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