Optimising Access to Vocational Rehabilitation Through Multiple Sclerosis Charities: A Feasibility Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Nottingham
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Health-related quality of life
Study Overview
Brief Summary
People with multiple sclerosis (MS) often leave the workforce prematurely due to MS symptoms and difficulties managing workplace relationships and performance. Vocational rehabilitation (VR) can improve job retention outcomes for people with MS, but there is a lack of evidence on the effectiveness of these interventions.
A psychologist and occupational therapist-delivered VR intervention was previously developed to support people with MS to remain in paid employment. This programme was tested in a community setting and within the UK National Health Service (NHS). The preliminary findings demonstrate that the intervention is highly acceptable to people with MS and their employers and helped participants with MS to meet their vocational goals. However, the study also identified various barriers (e.g., lack of staff, service structure, etc.) to delivering this programme more widely within a healthcare setting.
Because of this, patient and public involvement (PPI) representatives suggested testing the VR intervention within the services provided by MS charities. This approach could be beneficial to reach people with MS who might be in the earlier stages of the illness and looking for information or who have not considered discussing "work" with their healthcare providers.
Therefore, the VR intervention MSVR ("multiple sclerosis vocational rehabilitation") was adapted to be delivered by non-specialists working for MS charities. Over recent years, the practice of training non-specialists to deliver evidence-based and complex interventions has increased to reach communities where there is a lack of resources or to help increase the reach of these interventions.
This study aims to:
- Explore the feasibility and acceptability of providing employment support through MS charities.
- Determine the parameters for a future large-scale randomised controlled trial.
- Explore the experiences of those receiving and delivering the MSVR intervention.
Sixty people with MS in paid employment will be recruited to receive support with employment tailored to their needs over six months. Participants with MS will be asked to complete a booklet of questionnaires with variables known to affect employment status.
Approximately 20 participants will be asked to participate in a feedback interview at the end of the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
None (Open Label)
Eligibility Criteria
- Ages
- 18 Years to 66 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Can give informed consent,
- •Can communicate in English,
- •Are in paid employment (including self-employed).
Exclusion Criteria
- •Planning to retire within the next 12 months.
- •Currently receiving vocational rehabilitation support from the NHS or other employer services.
Arms & Interventions
MSVR
Participants in the MSVR group will be asked to complete a questionnaire booklet to explore variables of interest.
Participants will then be invited to an optional semi-structured, feedback interview to provide qualitative information on their experience of the intervention.
Intervention: Multiple Sclerosis Vocational Rehabilitation (MSVR) (Behavioral)
Control Group
Usual care
Outcomes
Primary Outcomes
Health-related quality of life
Time Frame: At baseline, and -6, -9 and 12-months post-randomisation.
The short form 36 health survey questionnaire measures eight health constructs relating to physical and mental health. The scale ranges from 0-100, with 100 representing highest level of health and functioning, and lower scores representing higher levels of disability. This measure has a high internal consistency (Cronbach's alpha \>0.80) and good test-retest reliability (\>0.70).
Work Productivity and Activity Impairment Questionnaire- Multiple Sclerosis
Time Frame: At baseline, and -6, -9 and 12-months post-randomisation.
This questionnaire includes questions about the employment situation of the person with MS, hours missed at work due to MS, and two numerical scales measuring how MS impacts productivity at work and conducting everyday activities. The numeric scales range from 0 (no impact) to 10 (unable to perform an activity), where a higher score represents a larger impact of MS at work and conducting everyday life activities. The recall will be extended from seven days to four weeks.
Secondary Outcomes
- Goal Attaiment Scaling(At baseline, and -6, -9 and 12-months post-randomisation.)
- Patient Health Questionnaire - 9 (PHQ-9)(At baseline, and -6, -9 and 12-months post-randomisation.)
- Generalised Anxiety Disorder - 7 (GAD-7)(At baseline, and -6, -9 and 12-months post-randomisation.)
- Perceived Difficulties Questionnaire(At baseline, and -6, -9 and 12-months post-randomisation.)
- Health-related quality of life(At baseline, and -6, -9 and 12-months post-randomisation.)
- Fatigue levels(At baseline, and -6, -9 and 12-months post-randomisation.)
- Self-efficacy(At baseline, and -6, -9 and 12-months post-randomisation.)
- Reasonable Adjustments(At baseline, and -6, -9 and 12-months post-randomisation.)
Investigators
Blanca de Dios Perez
Principal Investigator
University of Nottingham