Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Nordlandssykehuset HF
- Enrollment
- 114
- Locations
- 2
- Primary Endpoint
- Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version
Time Frame: Baseline, 9, 16 and 52 weeks post baseline
How frequently individuals with MS perceive psychological/cognitive (11 items), physical (8 items), external, (4 items) barriers related to work, scored by a 5-point scale (0=best).
Levels of physical activity measured using ActiGraph wGT3x-BT monitors
Time Frame: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
% of time in mild, moderate, intensive physical activity and sedate time
Secondary Outcomes
- Trunk Impairment Scale-modified Norwegian version (TISmodNV)(Baseline, 9, 16 and 52 weeks post baseline)
- Step count using ActiGraph wGT3x-BT monitors(Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline)
- Fatigue Severity Scale -Norwegian version(Baseline, 9, 16 and 52 weeks post baseline)
- Mini Balance Evaluation Systems Test (MiniBESTest)(Baseline, 9, 16 and 52 weeks post baseline)
- Postural control measured by AccuGait Optimized force platforms(Baseline, 9, 16 and 52 weeks post baseline)
- European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions(Baseline, 9, 16 and 52 weeks post baseline)
- 6 meter walk test(Baseline, 9, 16 and 52 weeks post baseline)
- Multiple Sclerosis Walking Scale-12(Baseline, 9, 16 and 52 weeks post baseline)
- Multiple Sclerosis Impact Scale 29-Norwegian version(Baseline, 9, 16 and 52 weeks post baseline)
- Patient Global Impression of Change - physical activity and balance(Baseline, 9, 16 and 52 weeks post baseline)