InterventionA randomised controlled trial of lay-led self-management for people with multiple sclerosis
Introduction
Multiple sclerosis (MS) is a chronic and often disabling condition of the Central Nervous System (CNS), affecting approximately 85,000 people in the UK [1] and 2.5 million people worldwide [2]. It is the most common neurological condition among young adults with onset typically occurring between 20 and 40 years of age and is characterised by inflammation and demyelination of the central nervous system. Symptoms may include debilitating fatigue, loss of function or feeling in the legs, loss of balance, loss of bowel and bladder control, sexual dysfunction, pain, loss of cognitive functioning and emotional changes [3]. Fatigue is a major symptom that persists over time and is independent of disability and mobility [4]. The course of MS can be an uncertain one, often characterised by progressive disability [5].
Multiple sclerosis can have a pervasive impact on all aspects of an individual's life and can disrupt family, social and working life [6], [7], [8]. Social impact can encompass lack of social support, social isolation and social withdrawal [6]. Clinical lifetime risk of depression is reported to be as high as 50% [9] with an annual prevalence of 20% [10]. Depression is often accompanied by anxiety, with lifetime prevalence reported to be 35.7% [11]. Other psychosocial aspects include increasing thoughts of self-harm, somatic complaints and social dysfunction [12]. Mood disturbance in MS has been correlated with decreased use of active coping strategies [13], which has adverse implications for ability to self-manage. Thus, the uncertain nature of MS combined with progressive disability, pervasive psychosocial impact and wide variability in the experience of MS [14] have to be considered in attempts to promote successful self-management. This suggests that people with MS require a wide range of self-management skills that may need to be adjusted and revised over time.
One non-specific (i.e. generic), lay-led self-management intervention that provides participants with a range of skills and strategies is the Chronic Disease Self-Management Course (CDSMC) [15] that is being delivered in a number of countries (e.g. UK, US, Australia, Canada). This intervention is not disease-specific; rather participants with any chronic disease can attend together. The focus of the CDSMC is the promotion of the individual's ability to select the self-management tool that will meet her individual needs at that time. In the UK, delivery of the CDSMC was pioneered by voluntary organisations including the Multiple Sclerosis Society and was later adopted as the foundation of the Department of Health's Expert Patient Programme (EPP) that was rolled out across primary care in England. In 2006, the EPP Community Interest Company (EPP-CIC) was established with the remit of organising course delivery and increasing availability. Thus, there will be more opportunities for people with MS to attend generic, lay-led self-management training in the community.
The CDSMC comprises six, weekly sessions, each lasting approximately 2 h, and is delivered in community settings (e.g. church halls) by pairs of lay tutors trained in course delivery. Each session is guided by a Leaders’ manual to ensure consistency of content. The CDSMC utilises the tenets of self-efficacy theory [16], providing mastery experience, role modelling, persuasion and reinterpretation of physiological and affective states to assist participants in making changes. The CDSMC covers generic topics including: an overview of self-management principles, exercise, pain and fatigue management, relaxation techniques (e.g. guided imagery and breathing exercises), dealing with depression, nutrition, communicating with family and health professionals, problem solving and goal setting. Goals should be achieved during the following week, be personally relevant, achievable, challenging, have proximal outcomes and depend largely upon a person's own efforts. Participants report back to the group on their achievements at the next weekly session. The format of the course is largely interactive, with short ‘lecturettes’ to introduce topics, group discussion, problem solving, role plays and mastery experience (i.e. trying out the skills introduced on the course). Participants are encouraged to apply these generic skills to their own situation. Tutors are trained and accredited to a rigorous set of quality standards (i.e. Stepping Stones to Quality), with training and course delivery focusing on adherence to protocol to ensure content and delivery fidelity. (See www.expertpatients.co.uk for full descriptions of course content, tutors training programme and quality assurance framework.) The emphasis on enhancing self-efficacy and inclusion of topics such as managing fatigue, problem solving and dealing with depression, suggest that the CDSMC may be relevant for people living with MS. Moreover, there is evidence that certain coping styles including problem solving, challenging appraisals, personal health control and emotional release are important predictors of well-being in MS [17], [18]. Finally, people with MS can enrol on the course without the need for referral from a health professional. Hence, information about likely benefits of course attendance for people with MS specifically is needed.
In the US, randomised controlled trials (RCT) have found the CDSMC to be effective in improving self-efficacy, use of self-management techniques, improving physical and psychological health status, and reducing health care utilisation among participants with arthritis, lung disease, heart disease and stroke [15]. A review [19] of four UK randomised controlled trials examining the effectiveness of the CDSMC [20], [23] and the lay-led Arthritis Self-Management Programme (ASMP) [21], [22] reported that self-efficacy improved in all studies, psychological distress improved in three studies [20], [21], [22] and generic quality of life improved in one study [20] based on intent-to-treat analysis. However, effect sizes were small to moderate and healthcare utilisation remained unchanged. The review focused on a limited range of outcomes and thus did not report effectiveness for outcomes such as positive affect [22], energy [20], exercise and relaxation [20], [22], cognitive symptom management [22], [23] and communication skills [22].
There are no published data on the effectiveness of the CDSMC specifically for people with MS. Given the fact that the course is now more readily available in the community and does not require referral form healthcare professionals, it is important that we understand more about the possible benefits for people with MS. The present study addressed this omission in a RCT aiming to determine effectiveness of the CDSMC for people with MS. In addition, we aimed to examine the characteristics of people with MS who expressed an interest in the CDSMC, received information about it, and subsequently consented to be part of the research (i.e. complete assessments over the 12-month period of the study) but did not wish to attend the course. The research design included a nested qualitative study, which has been completed [24]. Results showed that overall, some participants learned new self-management techniques and reported enhanced confidence (self-efficacy), whereas others were already confident in their self-management ability and found the CDSMC acted as a reminder of techniques previously used. Relaxation, pacing, and goal setting were particularly valuable for managing fatigue. Improvements to the CDSMC were suggested, including the addition of specific MS information.
Section snippets
Methods
The study was a 2-group, randomised, wait-list controlled trial with additional data collected from a group of informed non-attenders, who were aware of the research and the CDSMC, yet indicated that they did not want to attend (informed non-attenders). These participants formed a Comparison Group (CG). No incentives were used to encourage responses from any of the participants.
Baseline
A total of 216 questionnaires were returned at baseline: 78, 64 and 74 in the IG, WLCG and CG, respectively. Overall, approximately 80% (170) of the sample responded at 4-month follow-up, with 56 (72%), 49 (77%) and 65 (88%) returning questionnaires from the IG, WLCG and CG, respectively. A total of 123 participants (57%) responded at 12-month follow-up, with 43 (55% of the original group), 32 (50%) and 48 (65%) in each of the IG, WLCG, CG respectively (see Fig. 1).
Overall, 73% of respondents
Discussion
Results of the RCT show that the CDSMC had an impact on participants with MS recruited via the community in terms of the primary outcome of self-efficacy and physical health status (a secondary outcome), with trends towards improvement on depression and MS self-efficacy. These improvements were maintained at 12-month follow-up. Although the general pattern of results was in the expected direction, effect sizes were small and few changes attained statistical significance. In this respect, our
Acknowledgements
The study was funded by a grant from the MS Society. We extend our thanks to staff from the MS Society for their support and cooperation with this research, to all participants who took part in this study and to Christina Hammond and Gareth Williams for assistance with data collection.
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2020, Multiple Sclerosis and Related DisordersCitation Excerpt :Relative to comparators, ten studies reported statistically significant improvements in anxiety scores (Pahlavanzadeh et al., 2017, Cavalera et al., 2019, Rigby et al., 2008, Amiri et al., 2016, Crescentini et al., 2018, Hoogerwerf et al., 2017, Bahrani et al., 2017, Grossman et al., 2010, Kolahkaj and Zargar, 2015, Lincoln et al., 2011) (including one study that reported a beneficial effect in trait anxiety but not state anxiety (Crescentini et al., 2018), and another that reported improved anxiety compared to only one of two comparator groups – the ‘information booklet only’ group, but not the ‘social discussion plus booklet’ group (Rigby et al., 2008)). The most frequently used tool to measure anxiety was the HADS (used in nine studies (Cavalera et al., 2019, das Nair et al., 2016, Forman and Lincoln, 2010, Nordin and Rorsman, 2012, Rigby et al., 2008, Hoogerwerf et al., 2017, Barlow et al., 2009, Bogosian et al., 2015, Lincoln et al., 2011)), followed by the State-Trait Anxiety Inventory (STAI; used in four studies (Amiri et al., 2016, Crescentini et al., 2018, Tesar et al., 2003, Grossman et al., 2010)) The most frequently used BCTs were: behavioural practice/rehearsal (18 studies (Pahlavanzadeh et al., 2017, Simpson et al., 2017, Cavalera et al., 2019, das Nair et al., 2016, Forman and Lincoln, 2010, Nordin and Rorsman, 2012, Khayeri et al., 2016, Schwartz, 1999, Amiri et al., 2016, Crescentini et al., 2018, Hoogerwerf et al., 2017, Tesar et al., 2003, Bahrani et al., 2017, Barlow et al., 2009, Bogosian et al., 2015, Grossman et al., 2010, Lincoln et al., 2011, Senders et al., 2018, Kayes et al., 2011)); social support (unspecified) (12 studies (Cavalera et al., 2019, das Nair et al., 2016, Forman and Lincoln, 2010, Khayeri et al., 2016, Rigby et al., 2008, Schwartz, 1999, Amiri et al., 2016, Alschuler et al., 2018, Bahrani et al., 2017, Barlow et al., 2009, Lincoln et al., 2011, Senders et al., 2018)); and social comparison (11 studies (Pahlavanzadeh et al., 2017, Simpson et al., 2017, Cavalera et al., 2019, Forman and Lincoln, 2010, Rigby et al., 2008, Schwartz, 1999, Tesar et al., 2003, Alschuler et al., 2018, Bahrani et al., 2017, Lincoln et al., 2011, Senders et al., 2018)). Of the ten effective interventions, eight used behaviour practice/rehearsal as a BCT (Pahlavanzadeh et al., 2017, Cavalera et al., 2019, Amiri et al., 2016, Hoogerwerf et al., 2017, Bahrani et al., 2017, Grossman et al., 2010, Kolahkaj and Zargar, 2015, Lincoln et al., 2011).