Developing a group intervention to manage fatigue in rheumatoid arthritis through modifying physical activity

Fatigue is an important symptom of rheumatoid arthritis (RA) [1]. Patients report fatigue as difficult to manage with little professional support [2, 3]. The multi-dimensional nature of RA fatigue has been largely ignored, with little treatment targeted specifically at this symptom [4]. Despite inclusion of fatigue measurement in clinical trials [5], few studies have explicitly addressed RA fatigue management.

RA fatigue has been associated with reduced participation in physical activity (PA) [6, 7]. However, meta-analyses suggest that PA may have a small beneficial effect on RA fatigue [8, 9]. To date, few studies have investigated interventions designed specifically to reduce fatigue, or examined fatigue as a primary outcome. The need to develop a specific PA fatigue management intervention that meets the needs of RA patients is evident.

Designing complex interventions to improve health outcomes requires systematic development to ensure they are likely to be worth implementing in clinical practice [10]. Complex interventions have several dimensions, including the number and difficulty of behaviours required by recipients and those delivering the intervention and the permissible degree of flexibility or tailoring of the intervention [10]. Involving stakeholders in a co-design process enables their experiences to be incorporated into the intervention, increasing the likelihood of it being acceptable to users and providers [11]. Using a co-design approach provides an opportunity to explore challenges, concerns and ideas for future implementation at an early stage, improving potential effectiveness and enhancing uptake, adoption and maintenance of the intervention.

UK Medical Research Council (MRC) guidance for developing complex interventions recommends three processes in early development:

Whilst MRC guidelines strongly advocate a theoretical basis, they do not provide detailed guidance on how to choose or apply theory. In recognition of this, the Behaviour Change Wheel (BCW) has been proposed as a comprehensive, systematic approach to intervention development based on established behaviour change theory [12]. The central behaviour system in the BCW is the theoretically-based Capability, Opportunity, Motivation – Behaviour (COM-B) model, that suggests a change in behaviour will require a modification in at least one of the following components: the ‘capability’ of a person to carry out that behaviour; the ‘opportunity’ for the behaviour to occur; and ‘motivation’ to perform the behaviour at that moment in time [12].

The BCW framework assists intervention developers in identifying potential concepts required for behaviour change, as well as aiding designers in analysing target behaviours and characterising interventions and their active components. It is supported by links to other theory-based resources, such as the Theoretical Domains Framework (TDF) [13] and a taxonomy of recognised behaviour change techniques (BCTs) [14]. It is recommended in UK National Institute for Health and Care Excellence (NICE) guidance for developing individual-level behaviour change interventions [15].

Few studies describe a collaborative co-design process for the development of PA interventions in RA [16, 17]. Despite recommendations for the use of theory in self-management interventions in rheumatology [18], few studies report how theory was used during development of PA interventions for RA [19, 20]. The aim of this research was to co-design an intervention with RA patients and healthcare professionals (HCPs) to support self-management of RA fatigue through modifying PA. Intervention development was guided by the MRC framework and based on existing evidence, RA patient and HCP preferences and priorities, underpinned by the BCW theoretical framework. The objectives were to 1) develop programme content; 2) design programme sessions and develop resources required for delivery; and 3) develop educational support materials.

Full methods are available elsewhere [21]. Intervention development (Fig. 1) was supported by a research team and patient research partners (PRPs) with experience of developing theory-based self-management interventions for rheumatic diseases. The multi-disciplinary research team had professional backgrounds in physiotherapy (VS, FC, NW), rheumatology nursing (SH) and rheumatology medicine (JK). Both PRPs (MM, MU) had a diagnosis of RA and had experienced fatigue, providing a perspective of the lived experience. PRP involvement in research improves research quality [22], with benefits including a fresh perspective, changes to study designs and novel outcomes [23].

This paper provides a detailed description of the development and co-design of a group-based RA fatigue self-management intervention based on modification of PA. Intervention development was based on MRC guidance for complex intervention development, and informed by contemporary behaviour change methodologies, including the BCW, TDF and BCT taxonomy. The resulting intervention aims to enable RA patients to develop their capability to self-manage fatigue through modifying PA, identify physical and social opportunities to support PA modification, and enhance motivation to modify PA within the context of their fatigue. The benefits of PA for managing fatigue in RA and other long-term conditions were identified from existing literature (phase 1a), and evidence of its use in clinical practice was provided by HCPs (phase 1b) and supported by participants (phase 2).

To our knowledge, this is the first study to provide evidence of RA patient and rheumatology HCP involvement, including extensive input from PRPs, in the co-design of a PA fatigue management intervention [34]. Consideration of implementation and participation issues and preferences of potential intervention users and those who might deliver it during development means that the intervention is likely to be acceptable to future users, and to translate into clinical settings [39].

Participant preferences influenced intervention design in several ways. For example, RA patients and HCPs indicated a desire for a face-to-face group programme, to provide an opportunity for shared experiences and vicarious learning. This finding suggests that other recent PA interventions for RA fatigue delivered on an individual basis [40, 41] may not adequately meet the needs of some RA patients. Whilst it is acknowledged that individual interventions may suit patients who do not like groups, results from the current study suggest that people with RA value social support that may be important for facilitating behaviour change. Group structures may facilitate formation of social networks which have been shown to influence health status and health-promoting behaviours, such as PA [42]. In addition, phase 2b HCPs reported that group delivery was consistent with current rheumatology practice, and potentially cost-effective, although this needs to be determined in future research.

Participant preferences determined the style of intervention delivery. The importance of choice and patient-led decision-making to facilitate motivation and engagement in behaviour change was emphasised by all participants, and use of MI techniques was recommended by HCPs. Placing patients at the centre of decision-making and enhancing autonomy regarding modification of PA to manage fatigue is a fundamental principle of this intervention. Interactive delivery processes were enhanced by selection of self-determination theory as an underpinning motivational theory. Person-centred approaches have been advocated for behaviour change interventions in musculoskeletal conditions [43] and have been successfully applied to promote PA in RA [44].

Recent PA interventions for RA fatigue have focused on individual home-based PA [40, 41, 45]. In the current intervention, inclusion of an education session and practical PA were important components. Patients wanted the opportunity to develop knowledge and practice using skills to enhance their capability to perform PA within a supportive environment. The group setting allows modelling of the behaviour by the group facilitator and other participants, and provides an opportunity for immediate feedback to facilitate behaviour change.

Challenges identified for implementation and service provision included location, timing and duration of sessions. Participants emphasised these must be suitable for patients, whilst taking into account local staffing and resource constraints. Key challenges included accessibility for people who work or who have other roles and responsibilities that prohibit attendance during the week. Rheumatology HCPs believed that flexible staffing arrangements may be possible within current services, but some patients may still not be able to attend face-to-face sessions. Future intervention development should explore alternative modes of delivery for these patients. For example, research has suggested that RA patients would be prepared to take part in internet-based interventions [46], suggesting this format may offer a viable alternative, whilst recognising that this removes the important supportive group environment.

The MRC guidance and BCW provided a systematic process for developing a comprehensive, evidence-informed group self-management intervention for managing RA fatigue through modifying PA. This preliminary stage of development was important to ensure explicit links between the underpinning theory, mediating pathways and intervention outcomes thus facilitating future implementation and evaluation. Consultation and collaboration with potential recipients and professionals who might deliver the intervention enhances the likelihood of acceptability and implementation in future clinical practice. The feasibility of further evaluation now needs to be determined by further investigation of acceptability, implementation and practicality of the intervention.