Contact information
Type
Scientific
Primary contact
Prof G.I.J.M. Kempen
ORCID ID
Contact details
Universiteit Maastricht
Faculty of Health Sciences
Department of Health Care Studies
Section Medical Sociolgy
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882204
g.kempen@zw.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
014-91-052
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Fear of falling in older adults in the community
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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).
Secondary outcome measures
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.
Overall trial start date
01/03/2002
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Age 70 or older, living independently in the community, reporting fear of falling and associated activity restriction.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
540
Participant exclusion criteria
Confined to bed, restricted by permanent use of wheelchair, on waiting list for nursing home admission.
Recruitment start date
01/03/2002
Recruitment end date
31/03/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universiteit Maastricht
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
Maastricht University, The Netherlands
Sponsor details
Faculty of Health Sciences and Care and Public Health Research Institute
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881738
voorlichting@facburfdgw.unimaas.nl
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15780139
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16139984
Publication citations
-
Protocol
Zijlstra G, van Haastregt JC, van Eijk JT, Kempen GI, Evaluating an intervention to reduce fear of falling and associated activity restriction in elderly persons: design of a randomised controlled trial [ISRCTN43792817]., BMC Public Health, 2005, 5, 26, doi: 10.1186/1471-2458-5-26.
-
Results
Zijlstra GA, Tennstedt SL, van Haastregt JC, van Eijk JT, Kempen GI, Reducing fear of falling and avoidance of activity in elderly persons: the development of a Dutch version of an American intervention., Patient Educ Couns, 2006, 62, 2, 220-227, doi: 10.1016/j.pec.2005.07.005.