The primary objective is to investigate if the use of the Online Exercise Coach enhances compliance with the follow-up exercise program. Therefore the primary objective is: 1. Are patients who used the OEC during their follow-up exercise treatment…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronic pain (low back pain, RSI, whiplash)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of this study is compliance with the exercise
follow-up program. Patients are asked to fill out a weekly diary to log the
frequency and duration of their exercise sessions and the type of exercises
they performed. In addition compliance is logged by means entries of the Online
Exercise Coach by the patient.
Secondary outcome
Secondary parameters:
b) Patients* preferences towards exercise follow-up treatment - A preference
elicitation questionnaire is used to investigate preferences for follow-up
care. These are explicit measures of benefit valuation for assessing
alternative health care interventions (Gerard et al, 2007). In this research we
investigate so called *stated preferences*; individuals* stated preferences in
hypothetical (or virtual) markets.
c) Patients* satisfaction with follow-up treatment - User satisfaction will be
measured by means of a self-constructed questionnaire since no standardized and
validated questionnaires are available to assess user satisfaction of
teletreatment services like the Online Exercise Coach. The Theory of Planned
Behaviour (TPB) (Ajzen, 1991) and the Technology Acceptance Model (TAM) (Davis,
1989; Davis, Bagozzi, & Warshaw, 1989), two models widely used and
well-supported in the uptake of ICT based services, are used as underlying
theoretical framework. The models suggest that behavioural intention is
preceded by a patient*s perceived usefulness, perceived ease of use, attitude,
social norm and self-efficacy. The items of the questionnaire will assess these
determinants and their intention to use the OEC.
d) Effectiveness of follow-up treatment
Pain intensity (assessed by means of VAS scales)/ the level of subjectively
experienced disability due to pain (assessed with the PDI, a self-rating scale
that contains 7 items for the domains: 1) family and home responsibilities, 2)
recreation - sports and leisure time activities, 3) social activity -
participation with friends and other acquaintances, 4) occupation - activities
partly or directly related to working, 5) sexual behaviour - frequency and
quality of sex life, 6) self-care - basic life-supporting behaviours and 7)
daily activities)/ the level of pain-related anxiety (assessed with the PASS20,
a scale that assesses self-reported levels of pain related anxiety) and hysical
and mental health (assessed by the SF36 that measures eight domains of health)
e) Technical feasibility will be measured by means of automatic data logging of
the Online Exercise Coach website. In addition, technical complaints of both
patients and health care professionals will be registered and analysed.
Therefore the professionals and patients are asked to log technical problems
and failures they encounter and report this to the researcher by email or
telephone.
f) Demographic characteristics.
Background summary
At present, physical exercises are a principal part of every multidisciplinary
programme for the treatment of chronic low back pain (Guzman et al, 2002). A
recent systematic review of Henchoz & Kai-Lik So (2008) found exercise to be
effective in the primary and secondary prevention of low back pain. Reviews and
randomised controlled studies inspected by the Cochrane Group also underscore
the importance of exercise training in the treatment of subjects with
persistent pain (Van Tulder et al.,1997, 2000; Ostelo et al., 2005). Results
from Rainville, Hartigan & Martinez (2004) underline these results. In
addition, Rossy et al (1999) found that those with chronic pain benefit greatly
from increased aerobic conditioning. Results from literature reviews are in
line with these results.
However, adherence to exercise programs remains problematic. Dropout rates have
ranged from 10% to 36% and many patients* exercise adherence levels decline
even further once they complete their program (Blanchard et al, 2003). Moore et
al (1998) showed that only 30% of their sample was engaging in regular
exercise.
As ICT makes it possible to deliver alternative models of service delivery,
home-based treatment becomes possible. Home-based exercise programs have to
potential to better meet preferences of patients and in this way enhance
exercise treatment compliance. For example, travel times is reduced, an
important barrier to compliance of regular outpatient exercise programs. In
addition, home based exercise programs offer the benefit of flexible exercise
hours and the advantage that a patient can fit the program within his/her daily
routine. Both benefits were greatly valued by the patient sample in the
research of Ruland et al (2000). Other research investigating perceived
barriers by patients to adhere to exercise programs confirm these results (Van
Baar et al, 2006; Jones et al, 2007) and underscore the benefits home exercise
could offer tot the patient. In addition, home-based programs foster
patient-empowerment and self-management, especially important in chronic
diseases. The patient learns to take own responsibility for his or her own
health and in this way there is a bridge between the *gap* of treatment and no
treatment at all, which may prevent a sudden relapse of the patient when
treatment stops. This so called *empowerment* of the patient fits in with the
current trend in healthcare. In summary, ICT based exercise programs have the
potential to overcome patients* perceived exercise barriers.
Online Exercise Coach (OEC)
In the present study, the Online Exercise Coach, an online tailored exercise
program, developed by Roessingh Research & Development and Roessingh en
Roessingh Revalidatie Centrum (in Dutch: Online Bewegings Coach) will be
subject of research. The OEC is deployed as six weeks follow-up care. After
patients completed their clinic-based treatment, each policlinic therapist
selects exercises suitable for the follow-up treatment for his patient, by
logging onto the website www.r-motion.nl. Following, the patient logs onto the
website and is able to compose his own weekly exercise schedule by selecting
exercises from the list of exercises his therapist selected. In addition
patients have the opportunity to view the exercises on their computer by
playing the video-files on the website. Also they are offered an email function
on the website where they can contact their therapist in case they have
questions about their exercises.
Treatment preferences
As ICT home-based exercise programs are hypothesized to be cheaper, more easily
performed and efficient compared to regular exercise programs, they may be
preferable for the treatment of chronic pain. But is it something patients
want? Patient preferences are of great importance as they offer the possibility
to select treatment that best matches the needs and expectations of the
patients. Gan et (2004) al state this improves compliance, treatment outcomes,
and ultimately satisfaction. Patients who receive their preferred treatment
might be better motivated and comply better with the treatment programmes and
report better outcomes (King et al, 2005). McPherson et al (1997) also suggest
a moderating effect of preferences on treatment effect.
However, the effect of patients* preferences on treatment outcomes remains
uncertain. A systematic review of King et al (2005) concludes that participant
or physician preferences influenced outcome results. But, evidence for moderate
or large preference effect on outcome was much weaker when only large trials
were taken into analyses and when baseline differences were taken into account.
When preference effects where evident, they were inconsistent in direction. On
the contrary, a recent meta-analysis of eight musculoskeletal trials proved
that patients* preferences were associated with treatment effects. Patients who
were randomised to their preferred treatment had showed a greater effect size
those who were indifferent to the treatment assignment.
In the field of telemedicine, preferences are not yet studied. In order to
develop new interventions that better suit the needs of patients and in this
way enhance compliance rates, treatment outcomes and patients satisfaction, it
is important to investigate patients* preferences regarding telemedicine
interventions.
Study objective
The primary objective is to investigate if the use of the Online Exercise Coach
enhances compliance with the follow-up exercise program. Therefore the primary
objective is:
1. Are patients who used the OEC during their follow-up exercise treatment more
compliant than patients who did not use the OEC?
Secondary objectives:
Preferences
2. What are the preferences of chronic pain patients regarding exercise
follow-up treatment?
a) Do chronic pain patients prefer the OEC or the traditional advice as
exercise follow-up treatment?
b) Which attributes of OEC and traditional advice exercise follow-up treatment
are considered as most important by chronic pain patients?
3. Do exercise follow-up treatment preferences change after patients completed
their follow-up treatment?
Satisfaction
4. How satisfied are patients on the factors of the intention-based models
(such as the TPB and TAM model: attitude, self-efficacy and/or social support,
perceived ease of use and perceived usefulness)?
5. Is the technical performance of the OEC sufficient for clinical use from the
end user perspective?
Clinical Effectiveness
6. Do patients* interference of pain, actual pain levels, pain related fear of
movement and general health change after six weeks of exercise follow-up
treatment?
7. Do patients who used the OEC during their follow-up score better on
interference of pain, actual pain levels, pain related fear of movement and
general health than patients who did not use the OEC?
Study design
The study design is a 'randomized controlled trial' (RCT) in which the
intervention group receives the Online Exercise Coach. The control group
receives the traditional follow-up treatment.
Intervention
Subjects in the experimental group will receive six weeks of OEC follow-up
treatment. Patients have access to their online tailored exercise programs by
logging onto the website www.r-motion.nl. Patients* former policlinic therapist
will select a broad range of exercises from which the patient can choose from
to create his own exercise programme. The exercises consist of mobilizing,
muscle strengthening and conditional exercises. In addition patients have the
opportunity to view the exercises on their computer by playing the video-files
on the website. Also they are offered an email function on the website where
they can contact their therapist in case they have questions about their
exercises.
The control group comprises of a six week exercise follow-up program by means
of once-only instruction by word of mouth at the end of the policlinic
treatment at *Het Roessingh*. If patients experience problems during their six
weeks of follow-up treatment they are instructed to call their therapist.
Patients in both the intervention and control group are asked to exercise for
30 minutes 3 times a week.
Study burden and risks
The OEC is estimated to have minimal risk as patients are trained in the
exercises presented during the follow-up treatment and learned to recognize
their own boundaries. In addition, the exercises patients will perform during
follow-up treatment are approved by the clinical physicians. The burden to the
patients exists of filling in questionnaires and investing time to learn to
operate the OEC. Potential risks and burden outweigh the potential benefit
patients receive, as they have the opportunity to receive detailed information
on what and how to execute exercises during their follow-up treatment. In
addition, patients contribute to the development of better follow-up treatment
for future patients. The ultimate goal is to develop a follow-up treatment that
serves the needs and preferences of chronic pain patients.
Roessinghsbleekweg 33b
7522 AH Enschede
Nederland
Roessinghsbleekweg 33b
7522 AH Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Chronic low back pain, RSI, whiplash
Age of 18 years or older
Succesful completion of policlinic treatment at 'Het Roessingh'
Exclusion criteria
Insufficient control of the Dutch language
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 |
---|---|
Other | in behandeling bij NTR |
CCMO | NL25915.044.08 |