Controlled Study on the Effectiveness of a Dutch Can Do Training (CDT) in People with Relapsing Remitting Multiple Sclerosis

In people with MS (PwMS) symptoms and disabilities often negatively affect
self-reliance. As a result many PwMS loose their self-efficacy and autonomy.
Importantly, loss of self-efficacy and autonomy has been shown to result in a
decrease in health-related quality of life. One of the consequences of these
developments is that PwMS do more appeal to their partners or care givers.
In the U.S.A. a program (Can Do Training, CDT) has been developed that offers
PwMS a way to regain their capabilities and self-efficacy. It consists of an
intensive training given by a multidisciplinary team of health care
professionals.

In a 12-month pilot study we investigated the feasibility and potential
effectiveness of modified Dutch version of CDT. This CDT variant consists of a
3-day training (in contrast to the 5-day program in the U.S.A.) and also
includes the partners of the PwMS.The available data indicate that this CDT
program is fasible, as of the 97 participants only 7 (7%) discontinued the
training prematurely. However, for PwMS who had recently been diagnosed the CDT
turned out to be (too) confronting due to the presence in the groups of people
with advanced disease and disability. We also noticed an evident need of CDT in
PwMS with no partner.

Moreover, an analysis (N=44) of the 6-month data showed statistically
significant differences between participants with relatively few symptoms and
limitations (Expanded Disability Status Scale [EDSS] score <4,0) vs. those with
more symptoms and limitations (EDSS score >4,0), and also between participants
with Relapsing Remitting MS (RRMS) vs. those with progressive MS. In the
EDSS<4,0-group and the RRMS group significant improvements were seen in various
outcomes, whereas in the EDSS>4,0-group and the progressive group no
improvements were seen. The Multiple Sclerosis Self-Efficacy-Control (MSSE-C)
score in the EDSS<4,0-group had increased by 17,3% (mean) and in the RRMS group
with 24,8% (mean). In addition, in the RRMS group the mental Multiple Sclerosis
Quality of Life-54 Items (MSQoL-54) score had increased by 22,3% (mean) and the
physical MSQoL-54 score by 12,7% (mean).

To investigate the effect of a Dutch Can Do Training (CDT) on self-efficacy in
people with Relapsing Remitting Multiple Sclerosis.

In the periode from April to December 2013 5 CDTs will be given in weekends,
one CDT per weekend. Per CDT a control group will be formed that receives no
CDT. Both groups complete questionnaires at the same time points. The time
points are: one week before CDT, 1 month after CDT and 3 and 6 momths after
CDT.
Participants will be randomized.
Primary endpoint is the Multiple Sclerosis Self-Efficacy-18 control score.

CDT consists of training programs tailored to the personalized goals of the
individual participants. The training is given by a team of experienced healh
care professionals (neurologisct, MS-specialized nurse, psychiater, psychiatric
nurse, physiotherapist, yga teacher). The aim of the training exercises is to
explore the personal limits and thus to increase one's capabilities related to
the individual goal, which can be physical or mental.

Burden and risk.
For PwMS in the CDT group: During CDT the participants explore their limits by
goal-oriented, individualized, tailored and intensive mental or physical
exercices. It has been known that PwMS may experience a temporary worsening of
symptoms (e.g. fatigue) after intensive physical of mental strains. These
changes do not result from an increase in inflammation, completely disappear
after rest, and constitute a so-called pseudo-relapse. A true relapse is only
related to stress in as far it is mental, negative and chronic.
Confrontation with one's limitations and handicaps might illicit new or intense
emotions. These situations are immediately recognized by the CDT team and
adequately handled.
For PwMS in both groups: The strain related to the completion of the
questionnaires is considered moderate as there are 4 time points in a 6-month
period, the completion per time point is 70 minutes at maximum, and the
questionnaires are MS-relevant.
For partners in the CDT group: During CDT the participants explore their limits
by goal-oriented, individualized, tailored and intensive mental or physical
exercices. To prevent this group from setting unrealistic goals, that might
potentially affect their health, the partners are counseled by the team CDT
members.
For partners in both groups: The burden related to the completion of
thequestionnaires is minimal: 4 times in a 6-month period, with less than 20
minutes per time.
Risk for all participants: as the activities may be strenuous accidents might
happen, e.g. when walking through a forets.

Benefit
PwMS may regain lost capabilities and reconquer their autonomy and improve
health-related quality of life, whereas they may rebalance the relation with
their partners regarding autonomy (PwMS) and care-related stress (partners).