A randomised controlled trial of an online fatigue self-management group intervention for adults with chronic neurological conditions

Abstract

Background: Fatigue is one of the most common symptoms of neurological conditions. Although the literature suggests different approaches to treatment of this pervasive symptom, there is not a single, agreed comprehensive and well-supported approach to manage fatigue. There is strong evidence (Mathiowetz, Finlayson, Matuska, Chen, & Luo, 2005; Mathiowetz, Matuska, Finlayson, Luo, & Chen, 2007) that the face-to-face fatigue self-management program designed by Packer et al (1995) is effective in improving fatigue in people with MS. However, in Australia and many other developed and developing countries this program is not available for those people who have difficulty accessing services due to geographical location, transportation problems, work commitments or who lack confidence to participate in face-to-face programs. Equity of access is an important issue not only for this particular program but also for any self-management program in Australia (and internationally) which has a large rural and remote population. Evidence highlights the need for self-management programs to be delivered in different formats to ensure equity of access. One of the suggested ways is delivering the programs online. There is sufficient evidence that people with a disability have access to the internet. Thus, this project was designed to refine and further develop a pre-designed online fatigue self-management (online FSM) program and to evaluate it in a sample of adults with chronic neurological condition through a randomised controlled trial (RCT). Further, the study intended to explore who and how people with fatigue improve in their health outcomes.Methodology and Results: The aims of the project were fulfilled through four studies: 1) a pilot study; 2) a randomised controlled trial of the online FSM program; 3) a comparison with the face-to-face FSM program; and 4) exploration of predictors of improvement.During the pilot study, three pilot tests were conducted for the purposes of formative evaluation and to make necessary changes to improve the program. During the third pilot test, the effectiveness of the online FSM was also tested using a pre-test post-test design on a sample of individuals with multiple sclerosis, Parkinson’s disease or post-polio syndrome. The pilot study resulted in a standardised 7-week online FSM program mimicking its face-to-face version. Participants were offered fatigue self-management skills through structured activities, sharing information and experiences, expressing their ideas or feelings and offering advice and support to one another. The participants in the third pilot study improved significantly on the Fatigue Impact Scale (p<.05) and showed a trend toward significance shown on the Personal Wellbeing Index (p=.08).The RCT, the second study, included 95 participants who were randomised into one of three groups: an online FSM, an information-only FSM (info FSM) and a control group. The groups were compared at three time points (pre-test, post-test and at 3-months follow-up) on Fatigue Impact Scale, Activity Card Sort and Personal Wellbeing Index (FIS, ACS and PWI). Sores on Generalized Self-efficacy (GSE), Duke Social Support Index (SSI) and Depression, Anxiety and Stress Scale (DASS) were also used as covariates. The results showed that although both the online and information-only FSM groups improved over time on the FIS and ACS (p < .05), they were not significantly different from the control group or from each other at any time point. The low power in all analyses when comparing the groups revealed that a larger sample size is required to detect possible differences between the online FSM and control groups. Results of the secondary analysis on a combined group (online FSM group plus info FSM groups) showed that the online FSM and info FSM group complemented each other. The combined group showed significant differences when compared to the control group. This further suggests that the need for a larger sample size.The literature suggests incorporating face-to-face interventions as one of the experimental conditions when testing the effectiveness of an online program. Therefore, in the third study, a face-to-face group was used as a non-randomized comparison group. As the online FSM program was designed to provide service for people who do not have access to the face-to-face program, randomisation of the participants to four groups (face-to-face FSM, online FSM, info FSM and control groups) was not feasible; restricting the inclusion criteria to participants who had access to both the face-to-face and online programs would have excluded the very people for whom the program was designed. Thus, this study compared a sample of 20 participants in a face-to-face FSM program with each of the three other groups (online FSM, info FSM and control groups) using a nonequivalent pre-test post-test study. The findings showed that after controlling for the baseline data these participants had better scores on the FIS than the control group at post-test while these results were not seen in comparison to the online and info FSM groups. The results of this study on the face-to-face FSM program in comparison with online FSM program suggest that the online and info FSM program were successfully mimicking its face-to-face version. Further, the differences in some outcome measures and some clinical and demographic characteristics clearly demonstrated that the participants with access to the face-to-face program were significantly different than those in the RCT study. The participants who volunteered for participation in the online FSM program had lower activity levels and higher fatigue levels than the participants who had access to the face-to-face program. It appears that the two versions of the program provide access to significantly different participants.The fourth study aimed to indicate predictors of improvement on the FIS, ACS and PWI. Regression analyses were performed to find whether baseline demographic, clinical characteristics and/or changes in clinical characteristics from pre-test to follow-up were predictors for positive health outcomes. In this study, 92 participants with complete data set (pre-test, post-test and follow-up) were included. In parallel to the results emerging in systematic reviews (Nolte, Elsworth, Sinclair, & Osborne, 2007; S. Taylor, 2005; Warsi, Wang, LaValley, Avorn, & Solomon, 2004), younger people with more severe baseline scores appear to be more likely to make clinically significant improvements in their health outcomes. Improvement in mood and selfefficacy of people with fatigue were found to be predictors of better results for fatigue. Another interesting finding of this study was that improvement in selfefficacy and stress helps people with neurological conditions to improve in their fatigue regardless of their activity level at baseline.Conclusion: While fatigue is a common problem for people with fatigue secondary to neurological conditions, this online FSM program is the first of its kind to be implemented. The primary purpose of the fatigue self-management program is to help the participants improve their everyday performance and quality of life by incorporating ‘energy conservation techniques’ and self-management principles into their own life. Through the application of the fatigue self-management program, occupational therapists and other health professionals expect that the participants will learn the self-management skills, make corresponding behaviour changes and experience a reduction in the effect of fatigue on their lives. New knowledge gained from this study can further support the idea of providing other self-management programs online. The results of this study also add to the growing body of evidence emerging regarding how information technology may assist with improving health outcomes related to chronic conditions. Further, some predictors of improvement in health outcomes in this group of people were determined. The findings provide some evidence of the potential benefits of online fatigue self-management program for people with chronic neurological conditions. Online interventions like the online FSM program represent an important strategy for bridging the gap in service for those who can not participate in face-to-face programs.