To systematically develop a mobile lifestyle application + counseling program for wheelchair users with a spinal cord injury or lower limb amputation. The intended application is aimed at promoting physical activity, healthy eating habits and…
ID
Source
Brief title
Condition
- Injuries NEC
- Spinal cord and nerve root disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Process factors: usability, ease of use and satisfaction with the app. These
factors are measured using semi-structured interviews.
The app to be developed will consist of 3 modules that focus on: 1) healthy
physical behaviour (physical activity); 2) healthy eating habits; and 3)
healthy relaxation and sleep habits. For evaluation of these 3 modules the
primary study parameters are as follows:
Module 1
- Physical activity will be measured using an activity monitor (acceleromete).
The participants will wear this monitor as a watch around the wrist for five
consecutive days (24 hours a day). The accelerometer data will be collected
before, halfway and after the intervention. In addition, physical activity will
be measured with an exercise diary that the participants can complete in the
app.
Module 2
- Total daily energy intake is measured with a 3-day food diary that will be
completed before and after the intervention.
- Body composition (bio-impedance analysis), body-mass index and waist
circumference are measured before and after the intervention.
Module 3
- The sleep-wake rhythm will be measured with the same accelerometer with which
physical activity is measured. From the accelerometer data the following
parameters will be distilled: total sleep time (time in bed), sleep period
(actual minutes of sleep), nocturnal awakening and sleep efficiency (ratio
between the total sleep time and the sleep period).
Secondary outcome
Secondary study parameters:
- Physical activity will be measured with the Physical Activity Scale for
Individuals with Physical Disabilities (PASIPD).
- Multidimensional fatigue will be measured with the 20 items of the Individual
Strength Checklist (CIS20R)
- Self-efficacy will be measured with the Dutch version of the General Self
Efficacy Scale (10 items) and the Spinal Cord Injury Exercise Self Efficacy
Scale (10 items).
- Health-related quality of life will be measured with the SF-36E. In this
enabled version of the SF-36 the items of the physical functioning scale are
adapted for use in wheelchair users.
Background summary
Physical inactivity, excessive weight and low vitality are highly prevalent in
wheelchair users with a spinal cord injury or lower limb amputation. During
clinical rehabilitation, they receive support in developing a healthy
lifestyle, however in the transfer from rehabilitation to the home setting they
face many challenges that hamper its maintenance. Therefore, professionals are
looking for a flexible approach with which they can respond to the individual
wishes and needs of their clients. They see a great deal of potential in the
use of a mobile lifestyle application. This enables them to set up a
stimulating program together with the client and to monitor the progress or
lack thereof. At the moment, however, there is no lifestyle application
available that can be used to promote an active lifestyle, a healthy diet and
healthy sleep and relaxation habits in wheelchair users.
Study objective
To systematically develop a mobile lifestyle application + counseling program
for wheelchair users with a spinal cord injury or lower limb amputation. The
intended application is aimed at promoting physical activity, healthy eating
habits and healthy sleep and relaxation habits, and can be used blended or
stand-alone. After development of the application and counseling program, these
will be evaluated through a pilot study.
Study design
Intervention stuidy (small pilot study). Thirty wheelchair users will use the
mobile lifestyle application for 12 weeks. They will use the app to set
individual lifestyle goals (aimed at healthy physical activity, eating and
relaxation/sleep behaviour) that they then try to achieve. Half of participants
will use the app 'stand-alone'. The other half will use the app 'blended' with
distant lifestyle counselling from a professional. The participants will be
randomly assigned to one of the two groups. Because the two groups are
relatively small we will not study differences between the groups. However, we
will use semitructured interviews to examine whether the two groups experience
differences in ease of use and satisfaction. This provides information whether
the app is suitable for both 'stand-alone' and 'blended' use.
Intervention
The participants will use the app to set individual lifestyle goals (aimed at
healthy physical activity, eating and relaxation/sleep behaviour) that they
then try to achieve. Half of participants will use the app 'stand-alone'. The
other half will use the app 'blended' with distant lifestyle counselling from a
professional. At the start of the intervention, all participants receive
instruction about, and demonstration of, the use of the app.
The participants in the 'blended' lifestyle counselling group are assigned a
lifestyle coach. The intervention starts with a face-to-face consultation (30
minutes) in which the coach and participant set individual lifestyle goals.
The coach then contacts the participant after 3, 6 and 9 weeks to discuss the
progress and, if necessary, to adjust the program. These counselling moments
last 10-15 minutes and take place via the app, telephone, skype or e-mail.
After 12 weeks, the program ends with a face-to-face interview (10-15 minutes).
The participants in the 'stand-alone' group will use the app independently. The
app provides them with a personalized lifestyle advice based on personal
characteristics and individual lifestyle goals. These participants will also
use the app to work on their lifestyle for 12 weeks.
Study burden and risks
- 1 x visit to the rehabilitation centre for the sports medical examination
(only applies to participants for which the researcher deems this necessary
based on their medical background [1 hour]), instruction on the use of the
activity monitor, bio-impedance analysis (BIA) and height and weight
measurement (30 minutes).
- 1 x visit to the rehabilitation centre for instruction on use of the app (1
hour). Participants for whom this is a problem receive this instruction at
home.
- 1 x visit to the rehabilitation centre for an interview to measure usability,
ease of use and satisfaction (45 minutes), BIA and weight measurement, and to
hand in the activity monitor (15 minutes).
- Completing 2 questionnaires (before and after the intervention, 30-45 minutes
each)
- Completing a 3-day food diary before and after the intervention.
- Wearing the activity monitor around the wrist 3 times for 5 days and nights:
before, halfway and after the intervention .
There are no significant health risks associated with participation.
Dokter Meurerlaan 6
Amsterdam 1067 SM
NL
Dokter Meurerlaan 6
Amsterdam 1067 SM
NL
Listed location countries
Age
Inclusion criteria
- Spinal cord injury or lower limb amputation
- At least partly wheelchair dependent
- Time since clinical rehabilitation * 1 year (chronic phase)
- Age * 18 years
- Access to a smartphone or tablet with internet connection and able to control it.
- Inactivity as defined by a reference score of <30 metabolic equivalent (MET) h/week on the Dutch Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Exclusion criteria
- Cognitive impairments that impede use of the mobile lifestyle app.
- Physical impairments that impede use of the mobile lifestyle app.
- Progressive disease
- Psychiatric disorders that impede participation.
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 | NL64035.048.17 |