This SWAT has identified and highlighted important factors from the perspectives of carers that influence decision-making on trial participation. As the focus of healthcare internationally is to increase community-based care and avoid admission to secondary healthcare facilities for as long as possible [15], compounded by a rapidly increasing older person population [16], many individuals may find themselves in a caring role for which they are ill-prepared [17, 18]. Evaluating interventions to support informal carers psychologically, socially, physically, or otherwise, is important. As a discrete group within the general population informal carers can be a hard to reach population, not least of all because of regional dispersity [19] and the cost, time and inconvenience that might be associated with taking part in a trial [19, 20]. Furthermore, where trials do recruit, attrition rates in studies on carers can be high, for example, from 25% to > 40% across studies [21, 22].
Understanding informal carers’ views of research will assist trial developers, and other researchers, accommodate their unique needs. Carer identity, specifically, research that will help raise awareness about carers was the number one collectively identified motivator for trial participation. This supports the earlier quote describing informal carers as a ‘hidden patient group’ [2] and raises consideration of a possible sense of isolation or loneliness that carers may experience in their caregiving roles. Trial developers and researchers, in efforts to enhance participation in trials involving informal carers, need to consider the explicit demands that the caring role places on carers. These, in particular, identified in this study, were difficulties with planning ahead (number 1 priority challenge) and being unable to leave the care recipient alone, or for any length of time, all of which have implications for the design of any future, similar, host trial.
Implications of SWAT-55 for a future host trial
The non-feasibility of the host trial at recruitment level implies that any plan for a future, similar trial needs to take cognisant of carers’ motivators and challenges, and would require a major rethink as to how the trial might be designed and implemented. For example, how informal carers come to know of a study (e.g. through a family member or friend, or through a leaflet), or their awareness of those conducting the study, were ranked overall, as being neutral or unimportant when deciding to take part in a trial. Thus advertising/invitational methods will not necessarily optimise recruitment to a future trial, rather other aspects of trial design, such as the value the trial has for carers’ identity, and how the intervention is delivered will play a greater role. Carers in this study have clearly identified that their caring role leaves it difficult for them to plan ahead, to have time away from their care recipient, or to travel to study locations. This implies that a trialist needs to consider either offering the intervention online or, if offering it face-to-face, either i) cover the costs for alternative care for the care recipient, and time and travel costs or ii) have the interventionist travel to the participants homes or other location convenient to them. Given that the online format only marginally increased recruitment to the host trial, the latter options would appear preferable. These will have resource implications, however, in terms of personnel required and expense, which should be factored in to the future trial’s processes and budget. Flexibility in delivering the intervention is also required, and may involve late cancellations and rearranging interventionist visits. This will have implications on the time taken to deliver the intervention, and thus trial duration, an important issue to consider in future trial plans.
Challenges to conducting SWAT-55
A number of challenges in conducting the SWAT were encountered which may limit the results. These included limited recruitment to the host trial resulting in a reduced purposive sampling frame for phase 1 of the SWAT. Although rich data were provided by the two interviewees, a wider pool of participants might have better ensured, or at least increased our confidence in data saturation or sufficiency. This was overcome somewhat, however, by the extraction of data from related systematic reviews, and a triangulation of these data in developing the survey.
Despite extensive efforts, 36 participants only responded to the national survey, which is likely to represent a very small proportion of the population of informal carers across Ireland. Although we cannot be sure, the inability of Family Carers Ireland to distribute the survey via their email list, and the move towards distribution via Facebook, may have impacted on the survey response rate. We need to consider that had a larger number responded, providing greater caregiver representation, the ranked priority list of motivators and challenges might ultimately be different. The difficulties encountered with recruitment, however, could relate to how individuals identify with the concept of caring as evidence suggests that many individuals do not formally identify themselves as a carer or in a caregiving role [23]. For example, in a qualitative study of 40 relatives or friends, the researchers concluded that “…self-identification with the role and label of carer is nuanced, shifting and variable” [24] and refers to other studies that have shown variation in how relatives identify with the term carer [25, 26]. In one study, for example, exploring recruitment with carers of people with multiple sclerosis, participants suggested using the term ‘support’ or ‘assistance’ in place of the term ‘caregiver’ and highlighted that many people would not consider themselves to be carers [23]. This is an important consideration for researchers when advertising trials to an already hard to reach population, and how carers, including their associated roles, are described may need to be considered within trial participant information.