Condition category
Not Applicable
Date applied
07/10/2004
Date assigned
09/11/2004
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15780139
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16139984

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes