Effectiveness and cost-effectiveness of a self-management group program to improve social participation in patients with neuromuscular disease and chronic fatigue: protocol of the Energetic study

Abstract

BackgroundChronic fatigue is present in more than 60% of the patients with a neuromuscular disease and can be their most disabling symptom. In combination with other impairments, fatigue often results in low levels of physical activity and decreased social participation, leading to high societal costs. ‘Energetic’ is a self-management group program aimed at improving social participation, physical endurance and alleviating fatigue in these patients. The primary aim of this study is to evaluate the effectiveness and cost-effectiveness of the Energetic program.Methods/DesignA multicentered, assessor-blinded, two-armed randomized controlled trial is conducted with evaluations at inclusion and four, seven and fifteen months later. The study includes patients with a neuromuscular disease and chronic fatigue and, when present, their caregivers. The participants are randomized (ratio 1:1) to either an intervention group, receiving the Energetic program, or a control group, receiving usual care (i.e., no specific intervention). The Energetic program covers four months and includes four modules: 1) individually tailored aerobic exercise training; 2) education about aerobic exercise; 3) self-management training in applying energy conservation strategies; and 4) implementation and relapse prevention in daily life. Two months after cessation of the program a booster session is provided. The primary outcome is the perceived performance score of the Canadian Occupational Performance Measure (COPM). Secondary outcomes include the COPM-satisfaction score, and measures of fatigue, physical endurance, activity engagement, mood, and self-efficacy. Caregiver burden is also evaluated as a secondary outcome. Health-related quality of life and medical and societal costs are assessed to estimate cost-effectiveness of the program.DiscussionThe Energetic study is the first randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical and self-management group training program for improving social participation, physical endurance and alleviating fatigue in patients with neuromuscular diseases. It will generate new insights in (cost-)effective rehabilitation strategies for these incurable conditions.Trial registrationClinicaltrials.gov NCT02208687.

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations

“…102,192,196 Emotional support tends to have a more beneficial impact in people living with pain than does Assessment of Function16 instrumental support (doing things for people) as the latter can lead to learned helplessness. 12 Studies have shown that both network size and quality of social support at diagnosis of rheumatoid arthritis patients, for example, predicts pain and functional status 3-5 years later.…”

“…12 Studies have shown that both network size and quality of social support at diagnosis of rheumatoid arthritis patients, for example, predicts pain and functional status 3-5 years later. 55 Given the emerging relevance of social participation, we recommend that assessment of social participation be considered in chronic pain clinical trials when the investigator believes that this construct may be perceived as a moderator or mediator in shaping the outcomes for a particular population under study 101,196 (See http://www.immpact.org/static/meetings/Immpact17/Williams.pptx). We identified 37 potential measures in the literature of which 17 were particularly relevant to the discussion.…”

Validity and reliability of the Chinese version of the Daily Living Self-Efficacy Scale among stroke patients

“…There is some qualitative evidence supporting that participation in home and social activities is important for promoting self-management in stroke patients (Berges et al, 2012;Horne et al, 2014). Evidence also indicates that higher self-efficacy is associated with increased social interaction behaviors (Craig et al, 2015;Veenhuizen et al, 2015). The level of selfefficacy involved in psychosocial functioning plays an important role in well-being in stroke survivors (Maujean and Davis, 2013).…”

The “Managing Fatigue” programme for people with multiple sclerosis – acceptance and feasibility with Swedish occupational therapists

“…To date the programme's effectiveness has primarily been tested in North America [16,22,28] and Australia [20]; its merits are only beginning to be examined in European countries [23,29]. As such, despite its presence in the Swedish guidelines, the programme was essentially non-available in Sweden and there is a lack of research describing its use and feasibility in a Swedish context, with Swedish MS participants, and Swedish occupational therapists.…”