Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Participants will be randomised to either the group-based fatigue management intervention or current local practice.
1. Group-based Fatigue Management Intervention arm:
The manualised intervention con
Sponsors
Poole Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Providing written informed consent 2. Over the age of 18 3. Clinical diagnosis of relapsing-remitting or progressive multiple sclerosis 4. Score on the Fatigue Severity Scale > 4 5. Ambulatory (score on the Adapted Patient Determined Disease Steps Scale <8) 6. Able to attend the intervention sessions 7. English speaking
Exclusion criteria
Exclusion criteria: 1. Attended a specific fatigue management programme within the last year 2. Received a substantive, specific, fatigue intervention from an Occupational Therapist (OT) or other health professional, consisting of more than general advice, within the previous 3 months 3. Already involved in another research study 4. Cognitive deficits that would preclude engagement in the group format or benefit from the programme. This will be based on the judgement of health professionals/local investigators 5. A relapse within the previous 3 months 6. Individuals who have been on a disease-modifying drug or an anti-depressant for fewer than 3 months 7. Severe psychological disorders (individuals known to be currently under the care of a psychiatrist or addiction services)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Self-reported fatigue severity The Fatigue Assessment Instrument (FAI) (Schwartz,. Jandorf, & Krupp, 1993) is an expanded version of the unidimensional Fatigue Severity Scale (FSS). The FSS is one of the best known and most used fatigue scales. It principally measures the impact of fatigue on specific types of functioning. The FAI has four subscales: fatigue severity, situation specificity, consequences of fatigue and responsiveness to rest/sleep. Responses are made on a 7-point Likert-type scale. The fatigue severity subscale of the FAI corresponds almost exactly to the FSS, sharing eight of the original nine items along with three additional items. Scores on this subscale are a primary outcome. 2. Self-reported MS-specific quality of life The MS Impact Scale (MSIS-29) (Hobart, Lamping, Riazi, 2001) measures the physical (20 items) and psychological impact (9 items) of MS on day-to-day life. It uses 5-point Likert-type scales ranging from ?not at all? to ?extremely? and is based on quality of life in the last 2 weeks. The total score for the MSIS-29 is a primary outcome measure. 3. Self-reported self-efficacy for managing fatigue The Multiple Sclerosis-Fatigue Self-Efficacy scale (MS-FSE) is adapted from the Control subscale of the MS Self-Efficacy Scale developed by Schwartz et al., 1996. This adapted scale has undergone a preliminary validation in our pilot research. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-reported fatigue Three of the subscales from the FAI (namely, situation specificity, consequences of fatigue and responsiveness to rest/sleep) along with the total score of the FAI. 2. Self-reported fatigue impact The subscale scores of the MSIS-29 for the physical and psychological impact of MS. 3. Self-reported general quality of life 3.1. The Medical Outcomes Short-form Survey (SF-36) (Ware & Sherbourne, 1992) measures eight dimensions: physical functioning, role limitations because of physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations because of emotional problems, and mental health. It generates scores for the eight dimensions as well as two summary measures (physical health and mental health). It uses a combination of dichotomous and Likert-type response scales. This measure will also be used to calculate Quality Adjusted Life Years (QALYs) for the health economics analysis. 3.2.The EuroQOL (EQ-5D) is a standardised measure of health status developed by the EuroQoL Group (1990) in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ- VAS). The EQ-5D descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each rated on three levels (no problems, some problems, severe problems). The EQ VAS records the respondent?s self-rated health on a vertical, 20 cm visual analogue scale where the endpoints are labelled ?Best imaginable health state? and ?Worst imaginable health state?. 4. Self-reported mood The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983) is a self-report measure consisting of an anxiety and a depression subscale. Each subscale consists of seven items with a four-point Likert-type response scale. 5. Self-reported fatigue severity The Fatigue Symptom Inventory (FSI) (Hann | — |
Countries
United Kingdom
Outcome results
None listed