Clinical trial NCT06110468: Physical Function, Health and Employment for People With Multiple Sclerosis
Official title: Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Physiotherapy
Employment
Physical activity
Health related quality of life
Cost-benefit
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
name: University Hospital of North Norway
name: Nord University
name: UiT The Arctic University of Norway
name: Helgeland Hospital Trust
name: University of Tasmania
name: Norwegian Labour and Welfare Administration
First posted: 2023-10-31
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.

Detailed description: Physiotherapy and physical activity interventions can reduce fatigue, improve balance, walking, HRQoL, and may improve neuromuscular and physical functioning in people with MS. However, these interventions lack coordination between health care levels and sectors and rarely address vital employment adaptations. Optimizing function and physical activity, when disability is low and neuroplasticity is optimal, can be valuable for maintaining work as levels of fatigue, mobility related symptoms and cognitive disturbances are associated with current employment.

People with an MS-diagnosis who reside in the North of Norway will be identified from patient lists from the neurological out-patient clinics in the participating hospitals. Upon the provision of written informed consent, all participants will undergo baseline testing prior to randomization into either the intervention or the control group. The intervention group will receive a physiotherapy assessment at the hospitals focusing on opportunities for change. Following this assessment they will participate in group training with a municipality physiotherapist twice weekly for six weeks followed by independent training for six weeks. In addition, both participants and their employers will get access to information films on opportunities for work adaptations and the importance of physical activity. Structured meetings with a specially trained employment consultant, the participant and their employer will be held to discuss possible work adaptations. Goals will be set and formally evaluated. Retests will be carried out at week 9, 16 and 52. Registry data on employment will be obtained from the Norwegian labour and welfare administration as a part of a cost-benefit analysis of the intervention.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Multiple Sclerosis according to the McDonald's criteria
* Extended Disability Status Scale (EDSS) 0-4
* Being employed, part time or full time, may include various degrees of sick leave, disability pension or AAP.
* Living in the participating 18 municipalities (Hammerfest, Alta, Senja, Målselv, Tromsø, Harstad, Narvik, Fauske, Bodø, Meløy, Vågan, Vestvågøy, Sortland, Hadsel, Rana, Vefsn, Alstadhaug, Brønnøy).

Exclusion Criteria:

* Pregnancy at enrolment.
* Exacerbation of symptoms (i.e. relapse) within two weeks prior to enrolment.
* Other serious conditions.

Primary outcomes:
measure: Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Levels of physical activity measured using ActiGraph wGT3x-BT monitors
timeFrame: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
Secondary outcomes:
measure: 6 meter walk test
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Step count using ActiGraph wGT3x-BT monitors
timeFrame: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
measure: Fatigue Severity Scale -Norwegian version
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Multiple Sclerosis Walking Scale-12
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Mini Balance Evaluation Systems Test (MiniBESTest)
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Trunk Impairment Scale-modified Norwegian version (TISmodNV)
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Postural control measured by AccuGait Optimized force platforms
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Multiple Sclerosis Impact Scale 29-Norwegian version
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
measure: Patient Global Impression of Change - physical activity and balance
timeFrame: Baseline, 9, 16 and 52 weeks post baseline
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordlandssykehuset HF
state: Nordland
Study officials:
References: