(1) To compare the efficacy of two innovative preventative interventions with a control intervention in improving quality of life, cognition, work participation and productivity, brain plasticity and resilience, (2) to gain insight into the…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is change in quality of life as measured with the 36-item
Short Form.
Secondary outcome
Changes in cognitive performance (as measured with the neuropsychological
examination) will serve as secundary parameter. Additionally, changes on
questionnaires (concerning neuropsychological symptoms, work challenges and
participation, fatigue, anxiety and depression, resilience, stress and worry,
ability to participate in social roles and activity) will be included. Brain
changes will also be observed using MRI.
Background summary
Up to 70% of the patients with multiple sclerosis (MS) develop cognitive
deficits that severely affect daily life functioning and patients* quality of
life. Moreover, approximately 65% of all patients end up unemployed within five
years after diagnosis. Current treatments mostly focus on symptom management
and return to work, which may be too late. We hypothesize that timely
interventions will help prevent or delay cognitive decline and work-related
problems in patients with MS, thereby improving quality of life.
Study objective
(1) To compare the efficacy of two innovative preventative interventions with a
control intervention in improving quality of life, cognition, work
participation and productivity, brain plasticity and resilience, (2) to gain
insight into the experiences of patients and professionals regarding the
process and outcomes of the interventions using qualitative research methods,
and (3) to compare the cost-effectiveness of the interventions.
Study design
A randomized controlled trial with three arms and three follow-up visits for 16
months. Semi-structured interviews followed by focus groups will be used to
reflect on the process and outcome of the interventions.
Intervention
*Strengthening the brain* (4 month-program) consists of weekly 30 minutes
1-on-1 exercise and lifestyle coaching in combination with two moments per week
unsupervised exercises at home and a home-based online computerized cognitive
training. *Strengthening the mind* (4 month-program) consists of biweekly
contact with work coaches who are all diagnosed with MS themselves.
Study burden and risks
Cognitive and neurological assessments will be performed at the Amsterdam UMC
at four times (at baseline, post-intervention (month 0), short-term follow-up
(month 6), and long-term follow-up (month 16)). Additionally, online
questionnaires will be filled out at home at each timepoint after baseline.
Structural and functional brain MRI and blood sampling will be performed at
baseline, post-intervention and long-term follow-up. Additionally, an economic
evaluation will take place at all time points using an online questionnaire.
Risks are limited due to the often used and well-tolerable measurements and
interventions.
Van der Boechorstraat 7
Amsterdam 1081BT
NL
Van der Boechorstraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
- Confirmed MS diagnosis according to McDonald 2017 criteria
- Age between 18 and 67
- No changes in disease modifying therapy prior to inclusion (i.e. no changes
in last 3 months)
- No current relapse or steroid treatment in the six weeks prior to the study
visits
- Sublinical cognitive impairment
Exclusion criteria
- Patients with neurological (other than MS) and psychiatric disorders
- A current or history of drug or alcohol abuse
- Being unable to speak or read in Dutch
- Currently on sick leave and working for less than 12 hours for a period of 3
months or longer
Design
Recruitment
Medical products/devices used
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL82007.018.23 |