A randomised controlled trial of a self-management programme for fatigue in multiple sclerosis

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.

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 et al., 1998) is a 14-item self-administered multi-dimensional questionnaire that measures the severity, frequency and diurnal variation of fatigue and its perceived interference on quality of life. Severity is measured using four separate items that assess most, least and average fatigue in the past week, as well as current fatigue. Frequency is measured using two separate items that assess the number of days in the past week that respondents felt fatigued as well as the portion of the day on average they felt fatigued. Diurnal variation is measured using a single item that provides descriptive information about daily patterns of fatigue. Perceived interference is measured using seven separate items.
6. Self-reported sleep quality
These questions have been modified from the MS Clinical Practice Guidelines sleep questionnaire. Questions include duration and quality of night-time sleep, factors that may prevent or interrupt sleep, and daytime sleeping and sleepiness.
7. Self-reported resource utilisation
A resource utilisation questionnaire will be administered at 4- and 12-month follow-ups (i.e. 7 and 15 months post randomisation). It is adapted from one utilised in a large RCT in Parkinson’s disease and includes questions about health and social service contacts in the preceding 3 months.
8. Self-reported fatigue management strategies
At the 4-month follow-up (i.e., 7 months post randomisation) we will administer a semi-structured questionnaire to participants randomised to the FMP arm. In the questionnaire participants will be asked to describe whether they have tried to make any changes to their lifestyle, behaviour or thinking as a result of the intervention; whether these changes have been made successfully or unsuccessfully, and the reasons why.
9. Objective measure of physical activity
The activPAL™ accelerometer classifies an individual's free-living activity into periods spent sitting, standing and walking (www.paltechnologies.com). This information can be used to estimate daily energy expenditure, and time spent resting. Data will be collected at baseline and 1- and 4-month follow-ups (i.e., 5 weeks, 4 months and 7 months post randomisation). A postal method of administration was tested during an earlier research phase.
10. Self-reported satisfaction
Participants in the intervention arm will be asked to complete a brief semi-structured evaluation questionnaire at the end of each session of the fatigue management programme. This questionnaire was used in the pilot phases of the research (Thomas et al., 2010).