The primary objectives of the pilot study are to provide insight into the technical functioning, usability, acceptability, comprehensiveness, and feasibility of the monitoring and feedback & advisory system. Improvements will be made to theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Frailty, disability
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of the pilot study will be technical functioning,
usability, acceptability, comprehensiveness, and feasibility of the monitoring
and feedback & advisory system. Technical functioning will be measured by
recording the number of errors, technical failures, defects and their causes in
a logbook. Information regarding the usability, acceptability,
comprehensiveness, and feasibility of the system will be collected during
semi-structured interviews with the researcher and in logbooks that the
physiotherapist will keep.
Secondary outcome
The pilot study will provide insight into the development of parameters of
physical functioning over time. Measurements of weight, balance, grip strength,
and physical activity are collected for 3 months. These data will be compared
to information that was collected by the physiotherapist regarding health
events, periods of illness, and physical functioning. This will provide better
insight into how relevant changes in the physical functioning of participants
can be detected with the three devices.
Background summary
As society ages the prevalence of frailty and its adverse outcomes increases.
Disability is an adverse outcome of frailty that places a strain on frail
individuals and their caregivers. As a consequence, the demand for care and the
use of community services increases. Combined with a decreasing number of
caregivers this causes frailty to be a burden on health care systems.
Technological innovations can contribute to bridging the gap between demand and
supply of care in frail elderly people. During our research project, an
innovative system for monitoring physical frailty indicators (weight, balance,
gait, muscle strength, and physical activity) in community-dwelling older
people was be developed. The system gives feedback to the user about his/her
functional status and warns the user and/or care providers if a change in the
indicators occurs. Before the system can be evaluated it will be tested in a
small scale pilot study.
Study objective
The primary objectives of the pilot study are to provide insight into the
technical functioning, usability, acceptability, comprehensiveness, and
feasibility of the monitoring and feedback & advisory system. Improvements will
be made to the system based on the information that was obtained during the
pilot study. The secondary objective is to gain more insight into how relevant
changes in the physical functioning of participants can be detected with the
three devices.
Study design
For the pilot study, 5 participants will be recruited from the falls clinic of
the Orbis Medical Center in Sittard. The duration of the pilot study will be 3
months. At baseline, the researcher will visit the participants in their home
to install the system and to explain how the devices should be used. At the end
of every month, the researcher will have a face-to-face semi-structured
interview with the participants.
Intervention
The system consists of three devices that will be used daily by the
participants; a bathroom scale monitoring weight and balance, a Grip-ball
monitoring grip strength and a mobile phone with a built-in accelerometer
monitoring physical activity and gait. The information about these physical
indicators is sent to the mobile phone via blue-tooth. The users will receive
feedback and advice regarding their own physical functioning on the screen of
the mobile phone using text and/or spoken messages. The tailored advices relate
to individually relevant and realistic goals that aim to maintain or improve
physical functioning. The mobile phone also sends the information to an online
database that is accessible for the physiotherapist that is involved in the
pilot study. The physiotherapist will visit the participants after they have
used the three devices for 2, 6, and 10 weeks. During the visits the
physiotherapist will examine the physical functioning of the participants.
Besides that, the physiotherapist will discuss the measurements that were
performed with the three devices in the previous weeks with the participant.
Based on that, the physiotherapist and participant will collaborate to set
realistic and personally relevant goals that relate to the improvement or
maintenance of physical functioning. The physiotherapist will support the
participant in achieving these goals by providing tailored advice. This advice
in combination with the feedback and advice that is provided via the mobile
phone will support the participants in the self management of their own
physical functioning.
Study burden and risks
The risk that is associated with participation is minimal because the current
level of physical functioning will be the starting point of the therapy that
participants receive from the physiotherapist. There is a small possibility
that participants will focus too much on the measures of their physical
functioning because they are asked to measure this daily during the pilot study
whereas they do not do this in their normally.
The benefit that opposes the burden mentioned above is that participants get a
detailed insight into their own physical functioning. Because of this insight,
they receive care and advice that is tailored to their own needs which might
result in an improved physical functioning.
Universiteitssingel 40
6229 ER Maastricht
NL
Universiteitssingel 40
6229 ER Maastricht
NL
Listed location countries
Age
Inclusion criteria
- Community-dwelling
- Age: 70 years and older
- Frailty symptoms: moderate to severely frail as mearured by a score of 6 or higher on the Groningen Frailty Index (GFI), participants should score on the physical element of the GFI.
Exclusion criteria
- On a waiting list for intramural care
- Serious cognitive impairments: Mini Mental State Examination (MMSE) < 20
- Insufficient mastery of Dutch language
- Suffering from a fast progressive disease
- Being confined to bed
- Suffering from severe visual or hearing impairments.
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 | NL35961.096.11 |