A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol.

BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The majority of approaches for managing MS fatigue typically require participation in a structured, time-limited program with a fixed sequence of topics and activities. MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) is a self-directed MS fatigue management resource incorporating principles of self-management and adult learning. Positive results from a feasibility pilot study of a USB-delivered version of MS INFoRm led to the current trial and adaptation of MS INFoRm to a website format. The specific aims of the proposed study are to (a) to determine the effectiveness and efficacy of 3-month use of MS INFoRm on fatigue impact (primary outcome) among persons with MS, (b) to determine whether 3-month use of MS INFoRm results in improvement in secondary outcomes of self- efficacy for managing MS fatigue, self-reported cognitive function, participation and autonomy, and depression, and (c) to determine whether any improvements in primary and secondary outcomes are maintained among the MS INFoRm users after 6-months. METHODS/DESIGN: Parallel group, two arm, double-blinded superiority trial with a 1:1 allocation. Two hundred persons with MS will be randomly assigned to either an intervention (MS INFoRm) or usual care control group in which they will be given 3-month access to either the MS INFoRm website (intervention group) or a control webpage containing widely available resources on MS fatigue (control group). Baseline, immediate post-intervention (3-months), and follow-up (6-months post intervention) evaluations will take place on primary (Modified Fatigue Impact Scale) and secondary (Multiple Sclerosis Self-Efficacy Scale, Perceived Deficits Questionnaire, Center for Epidemiologic Studies Depression Scale, and Impact on Participation and Autonomy Questionnaire) measures. Hypothesis testing will involve independent samples t-tests and mixed effects ANOVAs. DISCUSSION: People with MS may benefit from easily accessible and self-directed fatigue management resources based on self-management and adult learning principles. The proposed study will provide crucial evidence about the potential of MS INFoRm as a self-management tool that can be made widely available to persons with MS as a means to effectively reduce the daily impact of MS fatigue. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03362541 . Posting date December 5, 2017.

The Experience of Persons With Multiple Sclerosis Using MS INFoRm: An Interactive Fatigue Management Resource.

We aimed to understand participants' experiences with a self-guided fatigue management resource, Multiple Sclerosis: An Interactive Fatigue Management Resource ( MS INFoRm), and the extent to which they found its contents relevant and useful to their daily lives. We recruited 35 persons with MS experiencing mild to moderate fatigue, provided them with MS INFoRm, and then conducted semistructured interviews 3 weeks and 3 months after they received the resource. Interpretive description guided the analysis process. Findings indicate that participants' experience of using MS INFoRm could be understood as a process of change, influenced by their initial reactions to the resource. They reported experiencing a shift in knowledge, expectations, and behaviors with respect to fatigue self-management. These shifts led to multiple positive outcomes, including increased levels of self-confidence and improved quality of life. These findings suggest that MS INFoRm may have a place in the continuum of fatigue management interventions for people with MS.

Traumatic injury and multiple sclerosis: a systematic review and meta-analysis.

A systematic review/meta-analysis of literature addressing a possible association between traumatic injury and onset of multiple sclerosis was conducted. Medline, Embase, Cochrane DSR, Ovid HealthStar, CINAHL, ISI Web of Science and Scopus were searched for analytical studies from 1950 to 2011. Two investigators independently reviewed articles for inclusion, assessing their quality using the Newcastle-Ottawa Scale. Of the 13 case-control studies included, 8 were moderate quality and 5 low; of the 3 cohort studies 2 were high and 1 moderate. Meta-analysis including moderate and low quality case-control studies produced a modest but significant odds ratio: 1.41 (95% confidence interval: 1.03, 1.93). However, when low quality studies were excluded, the resulting odds ratio was non-significant. Cohort studies produced a non-significant standardized incidence ratio of 1.00 (95% confidence interval: 0.86, 1.16). These findings support the conclusion that there is no association between traumatic injury and multiple sclerosis onset; more high quality cohort studies would help to confirm this observation.

The burden of multiple sclerosis: a community health survey.

BACKGROUND: Health-related quality of life (HRQL) in persons with multiple sclerosis (MS) who reside within the community relative to the general population is largely unknown. Data from the Canadian Community Health Survey Cycle 1.1 (CCHS 1.1) were used to compare HRQL of persons with MS and the general population. METHODS: A representative sample of adults (18 years or older) from the cross sectional population health survey, CCHS 1.1, was examined to compare scores on the Health Utilities Index Mark 3 (HUI3), a generic preference-based HRQL measure, of respondents with (n = 302) and without (n = 109,741) MS. Selected sociodemographic covariates were adjusted for in ANCOVA models. Normalized sampling weights and bootstrap variance estimates were used in the analysis. RESULTS: The mean difference in overall HUI3 scores between respondents with and without MS was 0.25 (95% CI: 0.20, 0.31); eight times greater than the clinically important difference. The largest differences in scores were seen with the ambulation (0.26; 95% CI: 0.20, 0.32) and pain attributes (0.14; 95% CI: 0.09, 0.19). Clinically important differences with dexterity and cognition were also observed. CONCLUSION: While the proportion of the Canadian population with MS is relatively small in comparison to other diseases, the magnitude of the burden is severe relative to the general population.

A pilot mixed-methods evaluation of MS INFoRm: a self-directed fatigue management resource for individuals with multiple sclerosis.

Fatigue management interventions for individuals with multiple sclerosis (MS) often feature structured programmes requiring repeated, in-person attendance that is not possible for all individuals. We sought to determine whether MS INFoRm, a self-directed fatigue management resource for individuals with MS, was worth further, more rigorous evaluation. Our indicators of worthiness were actual use of the resource by participants over 3 months, reductions in fatigue impact and increases in self-efficacy, and participant reports of changes in fatigue management knowledge and behaviours. This was a single-group, mixed-methods, before-after pilot study in individuals with MS reporting mild to moderate fatigue. Thirty-five participants were provided with MS INFoRm by a USB flash drive to use at home for 3 months, on their own volition. Twenty-three participants completed all standardized questionnaires, semi-structured interviews and study process measures. Participants reported actively using MS INFoRm over the 3-month study period (median total time spent using MS INFoRm=315 min) as well as significantly lower overall fatigue impact (Modified Fatigue Impact Scale: t=2.6, P=0.01), increased knowledge of MS fatigue (z=-2.8, P=0.01) and greater confidence in managing MS fatigue (z=-3.3, P=0.001). Individuals with significant reductions in fatigue impact also reported behavioural changes including tracking fatigue, better communication with others, greater awareness, improved quality of life and being more proactive. This study provides evidence that further rigorous evaluation of MS INFoRm, a self-directed resource for managing fatigue, is worth pursuing.

Health status and health care utilization of multiple sclerosis in Canada.

BACKGROUND: Persons with multiple sclerosis (MS) represent a small segment of the population, but given the progression of the disease, they experience substantial physical, psychosocial and economic burdens. OBJECTIVE: The primary aim was to compare demographic characteristics, health status, health behaviours, health care resource utilization and access to health care of the community dwelling populations with and without MS. METHODS: Cross-sectional survey using data from the Canadian Community Health Survey (CCHS 1.1). Adjusted analyses were performed to assess differences between persons with MS and the general population, after controlling for age and sex. Normalized sampling weights and bootstrap variance estimates were used. RESULTS: Respondents with MS were 7.6 times (95% CI: 5.4, 10.7) more likely to have health-related quality of life scores that reflected severe impairment than respondents without MS. Respondents with MS were 12.2 times (95% CI: 8.6, 17.2) to rate their health as 'poor' or 'fair' than the general population. Urinary incontinence and chronic fatigue syndrome were 18.7 times (95% CI: 12.5, 28.2) and 21.9 times (95% CI: 11.9, 40.3), more likely to be reported by respondents with MS than those without. Differences between the two populations also existed in terms of health care resource utilization and access and health behaviours. CONCLUSION: Large discrepancies in health status and health care utilization existed between persons with MS who reside in the community and the general population according to all indicators used. Health care needs of persons with MS were also not met.

Change in the Health-Related Quality of Life of Multiple Sclerosis Patients over 5 Years.

This study examined whether multiple sclerosis (MS) patients (N = 3779) experience change in their perceived health-related quality of life (HRQOL) over a 5-year period, and investigated baseline factors that may be related to change in HRQOL. Data from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry were used to address the study's research questions. Results for the physical and mental component scores of the 12-item Short Form Health Status Survey, version 2 (SF-12v2), indicated that most of the MS sample experienced no significant changes over a 5-year period. However, 40% and 36% of the sample experienced clinically significant declines in their physical and mental HRQOL, respectively, over the 5-year period. After controlling for baseline scores, having a lower education, having greater duration since disease diagnosis, not being employed, having a lower income, not receiving a disease-modifying therapy, and taking a greater number of prescription medications were significantly associated with a clinically significant decline in physical HRQOL. After controlling for baseline scores, not being married/partnered, experiencing a greater number of relapses, not being employed, having a lower income, and taking a greater number of prescription medications were significantly associated with a clinically significant decline in mental HRQOL. Overall, most of the MS sample remained stable in their HRQOL over time. However, approximately four out of every ten patients experienced a clinically important decline in their HRQOL. While the association was statistically significant, the sociodemographic and disease-related factors linked with decline did not strongly predict decline over a 5-year period.