The aim of this study is to investigate the (cost-)effectiveness of the 'In Balans' fall prevention program. We will research the effect of 'In Balans' on the number of falls, fall injuries, physical performance (including…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ouderdom en valrisico
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the number of falls (with and without injuries)
and will be assessed using fall calendars and monthly telephone calls during
the 12-month follow-up.
Secondary outcome
Secondary outcomes (assessed at baseline, at 4 months, and at 12 months) are
divided into physical tests and questionnaires.
Physical tests:
- Balance measured with the 'Performance - Oriented Mobility Assessment -
Balance', the 'Four Stage Balance Test' and the 'Timed Up and Go Test'
- Mobility measured with the 'Performance - Oriented Mobility Assessment -
Mobility'
- Muscle strength measured with the 'Hand Grip Strength Test', the 'Timed Chair
Stands Test' and the *Short Physical Performance Battery*
- Walking speed measured with the '10 Meter Walk Test '
- Aerobic endurance measured with the' 2-minute Step Test '
- Fall risk measured with the' LASA Fall Risk Questionnaire '
- Daily physical activity and gait based on data from movement monitors worn on
the lower back for 1 week
Questionnaires:
- Overall health status assessed by means of the 'Short Form Health Survey -
SF-36' and the 'Positive Health Inventory Tool'
- Self-determination assessed using the 'Pearlin Mastery Scale' and the
'General Self-Efficacy Scale'
- Fall anxiety assessed using the 'Falls Efficacy Scale International - FES-I'
- Confidence while walking assessed using the 'Modified Gait Efficacy Scale -
mGES'
- Frailty assessed using the 'Groningen Frailty Indicator'
Demographic characteristics (assessed at baseline and at 12 months):
Age, sex, weight, marital status, level of education, use of medication
(number), and presence of chronic disease.
The frailty status is determined based on the '5 Frailty Indicators': weight
(loss), weakness, fatigue, slowness and low physical activity.
Moreover, we will ask for the number, of falls, the cause (behavioral,
biological, environment), circumstances and consequences of falls (none, small,
medium, large) during the 12 month follow-up using the fall calendar and
monthly telephone calls
In order to determine cost-effectiveness (after 4, 8 and 12 months), we measure:
- Quality of life assessed using the 'EuroQol 5D' and the 'and the Adult social
care outcomes toolkit (ASCOT)'
- Healthcare, patient and family costs assessed using the 'iMTA Medical Cost
Questionnaire (iMCQ)
- Productivity costs assessed using the' iMTA Productivity Cost Questionnaire
(iPCQ)
Background summary
Falls are the leading cause of injury in the elderly. Training in the form of a
fall prevention program can reduce the risk of falls and injury. Moreover, a
fall prevention program could increase self-confidence during walking. 'In
Balans' is such a fall prevention program that is already being used.
One previous study, conducted in 2006, investigated the effectiveness of an 'In
Balans' program of 20-weeks in elderly people living in a care home. This study
found that participating in the 'In Balans' program resulted in a 61% reduction
in the risk of falling in prefrail older people, but had no effect in frail
older people. Currently, the duration of the 'In Balans' training is14 weeks
and mainly particpated by non- and prefrail community-dwelling older adults.
The effect of 'In Balans' in its current form has not yet been evaluated.
Therefore, we want to investigate the (cost-)effectiveness of the 'In Balans'
training in older adults living at home with an increased risk of falling.
Health insurance companies ask for proof of effectiveness in order to be able
to decide whether the 'In Balans' program will be reimbursed or continue to be
reimbursed. If the effectiveness of the 'In Balans' program is clear, paying
parties will be more motivated to invest in 'In Balans'. This could enable more
older adults to participate in and benefit from the 'In Balans' program in the
future. Therefore, results of this study will help health care professionals,
policymakers and paying parties to prevent falls in older adults in a timely
and effective manner.
Study objective
The aim of this study is to investigate the (cost-)effectiveness of the 'In
Balans' fall prevention program. We will research the effect of 'In Balans' on
the number of falls, fall injuries, physical performance (including balance,
strength and walking speed), physical activity, health and quality of life. We
also want to examine the cost-effectiveness from a social perspective.
Study design
This study is a single-blind, multicenter randomized clinical trial (RCT) with
12 months of follow-up. Participants are stratified and randomized by their
frailty score according to Fried et al.. These criteria are having a low body
weight (BMI <18.5), low grip strength, fatigue (SF-36 vitality score <75), slow
walking speed and low physical activity. If a participant does not meet any of
these criteria, the participant is classified as non-frail. If a participant
meets 1 or 2 criteria, the participant is classified as pre-frail. If a
participant meets 3 or more criteria, the participant is classified as frail
and will be excluded from the study. Participants are randomized according to
their frailty status (1:2 pre-frail versus non-frail older adults in the
intervention and control group).
Intervention
'In Balans' is a fall prevention program of 14 weeks that will be provided by a
certified physiotherapist or remedial therapist who has followed a training
program to become an 'In Balans' trainer. The 'In Balans' program is followed
in a group with a maximum of 12 people. The first 4 weeks consist of 1 meeting
per week in which information is given about the impact a fall can have on the
subjects' life, the purpose of the 'In Balans' program, creating awareness
about the subjects' fall risk and balance disturbances, how to deal with
effective fall prevention methods and become familiar with the coming training
weeks. The remaining 10 weeks consist of 2 meetings per week of 1 hour per
meeting in which exercises aimed at balance, strength and mobility will be
executed. These exercises are derived from the principles of Tai Chi.
The control group will receive written general recommendations on balance,
strength and physical activity according to the Dutch guidelines for physical
activity, drawed up in 2017.
Study burden and risks
As far as the researchers can assess, there are no risks associated with the
study. The training program is harmless, but may cause discomfort. For example,
participants may experience muscle pain when starting with the 'In Balans'
program. This muscle pain normally lasts 1 to 2 days. Furthermore, the
participants could experience discomfort when wearing the movement monitor.
Moreover, the burden for the participants is low. The subjects who are assigned
to the intervention group follow the 14-week 'In Balans' fall prevention
program that is provided by a certified physiotherapist or remedial therapist
who has followed training to become an 'In Balans' trainer. The first 4 weeks
of the 'In Balans' training consist of 1 meeting per week in which information
is given about falls and fall prevention. The remaining 10 weeks consist of 2
meetings per week in which exercises aimed at balance, strength and mobility
will be done. The control group receives written general guidelines on physical
activity, drawed up in 2017. During the 12 months study, there are 3
measurement moments of approximately one hour per measurement moment,
participants wear a movement monitor 3 times for 1 week and have a telephone
conversation of approximately 15 minutes with 1 of the researchers once a
month. It is important that the (cost-)effectiveness of the 'In Balans' program
is investigated, because paying parties will then be more motivated to invest
in the 'In Balans' program. This could enable more older adults to participate
in and benefit from the 'In Balans' program in the future.
van der Boechorststraat 9
Amsterdam 1081 BT
NL
van der Boechorststraat 9
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
65 years of age or older
Increased fall risk according to the fall risk assessment of VeiligheidNL
Able to read and understand Dutch
Being able to independently take care of themselves (e.g. going to the
bathroom, dressing and undressing) and walk 100 meter
Classified as non- or pre-frail, based on the frailty criteria according to
Fried et al.(body weight (BMI >18.5), grip strength, fatigue (SF-36 vitality
score >75), walking speed and physical activity)
Exclusion criteria
Younger than 65 years of age
No increased fall risk according to the fall risk assessment of VeiligheidNL
Indications of serious cognitive problems (MiniMental State Examination <19 /
30)
Classified as frail according to the frailty criteria of Fried et al. having a
low body weight (BMI <18.5), low grip strength, fatigue (SF-36 vitality score
<75), slow walking speed and low physical activity)
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 | NL75305.028.20 |