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
| ISRCTN | ISRCTN43792817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43792817 |
| Protocol serial number | 014-91-052 |
| Sponsor | Maastricht University, The Netherlands |
| Funder | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 07/10/2004
- Registration date
- 09/11/2004
- Last edited
- 01/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Universiteit Maastricht
Faculty of Health Sciences
Department of Health Care Studies
Section Medical Sociolgy
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882204 |
|---|---|
| g.kempen@zw.unimaas.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 540 |
| Key inclusion criteria | Age 70 or older, living independently in the community, reporting fear of falling and associated activity restriction. |
| Key exclusion criteria | Confined to bed, restricted by permanent use of wheelchair, on waiting list for nursing home admission. |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6200 MD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2006 | Yes | No | |
| Protocol article | protocol | 21/03/2005 | Yes | No |
