With a randomized controlled crossover trial the effect of using this tool on mobility, fall risk and well-being, and its effect on self management of fall risk will be assessed. Costeffectiveness of this strategy to improve self management of fall…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
de deelnemers aan de Senior Stap Studie kunnen elke aandoening hebben, hier worden ze niet op geselecteerd.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gait speed, falls, well-being and self management.
Secondary outcome
Mobility, fall-related injuries, mobility range and fear of falling.
Cost-effectiveness of the self management tool. Feasibility, contentment and
motivation of elderly to use the self management tool.
Background summary
Falling is an important problem among community-dwelling elderly. The number of
falls and concomitant health costs will rise within an aging population. Fall
related injuries and fear of falling decrease mobility and have a negative
impact on social functioning, mood, well-being and autonomy. Research from a
medical perspective has concentrated on casefinding and fall prevention.
Currently, insufficient possibilities are available for elderly and caregivers
to assess and improve their own mobility and fall risk. The Senior Step Study
aims to provide a tool for elderly to improve their self management abilities
in monitoring and improving fall risk and thus mobility.
Study objective
With a randomized controlled crossover trial the effect of using this tool on
mobility, fall risk and well-being, and its effect on self management of fall
risk will be assessed. Costeffectiveness of this strategy to improve self
management of fall risk will be compared with regular care after an accidental
fall. Qualitative research will study the feasibility, contentment and
motivation of elderly to use such a self management tool.
Study design
A randomized controlled crossover trial of six months will be executed among
150 frail elderly (70+ years) within three settings: at home, a home for the
elderly and a community center. With this design the elderly serve as their own
control. the elderly in the intervention group will use the tool weekly for
three months to measure their gait speed. Also, they will receive an
instruction book which they can use to train their balance and mobility on the
basis of the results from the tool. The control group will receive only the
instruction book, which they can use at their own discretion. After three
months, both group wil switch between the intervention group and the control
group.
During the study all participants will be followed with the falls telephone to
register and monitor the number of falls.
After the study a small group of participants will be asked to participate in a
qualitative interview using semistructured interviews, to uncover the
feasibility, contentment and motivation of elderly to use such a self
management tool to monitor their own mobility and fall risk.
Intervention
Weekly use of the self management tool to measure and monitor mobility and fall
risk.
Study burden and risks
Subjects will participate for six months. During those months they will receive
weekly calls from the falls telephone. Also, they can train their balance and
mobility using the instruction book, at their own discretion in the control
group and on basis of the self management tool in the intervention group. By
use of a diary they can register if and what exercise they performed that day.
When the participant is in the intervention group, they will use the self
management tool once a week.
During the study the participants will receive seven small assessments which
will be performed by the researcher and the researcher's assistent (T0 - T6).
All assessments take place at home, the home for the elderly or in the
community center.
T0 is at baseline of the study and will consist of the following tests: Minimum
Data Set (of the Dutch National Program for the Care for Elderly), SMAS-30
(questionnaire for self management), MOS-20 (well-being), LAPAQ (mobility
range), (m)-FES (fair of falling), Timed Up and Go test and the Short Physical
Performance Battery (both a measure for balance and mobility). This assessment
will take approximately 1.5 hours and will be repeated after three months when
both groups will switch (T3), and at the end of the study (T6).
During the other assessments (T1, T2, T4, and T5) only the Timed Up and Go test
and the Short Physical Performance Battery will be measured to register changes
in balance and mobility.
At the end of the study qualitative research will take place through
semistructured interviews in a small group of participants coming from all
participating centers. With these interview the feasibility, contentment and
motivation of elderly to use a self management tool for monitoring balance and
mobility will be assessed.
There will be no invasive tests performed in the participants which indicate
that there will be no risks associated with participation.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
1. Subjects of 70 years and over
2. Subjects who experienced at least 1 fall in the previous year
3. Subjects who can walk independently or with a walking aid
4. Informed consent on the basis of Dutch legislation (WMO)
Exclusion criteria
1. Subjects not able to peak Dutch
2. Subjects not able to understand and remember simple Dutch instructions
3. Subjects not capable of using the falls telephone, only when there is no informal caregiver who can answer the falls telephone
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41111.091.12 |