Prioritising key motivators and challenges influencing informal carers’ decisions for participating in randomised trials: a Study Within A Trial (SWAT-55)
Abstract Background: Family members, or others, often assume the role of informal (unpaid) carers of people with chronic illnesses. Care-giving, however, can impact profoundly on the quality of life of caregivers and can cause carer worry, stress and guilt. Implementing interventions that positively affect the lives of carers is important, however, carers as a group are often difficult to reach. We embedded a study within a pilot-feasibility study of a mindfulness based intervention for carers of people with chronic illness to determine the key motivators and challenges influencing informal carers’ decisions for participating in a trial, and to prioritise these to inform future trial design and conduct. Methods: We conducted a Study Within A Trial using a multi-method approach involving interviews with participants from the ‘host trial’ and data from systematic reviews to develop a survey that was distributed to informal carers across Ireland. The survey consisted of 28 motivator and 17 challenge statements. Participants rated how important they thought each statement was when deciding to take part in a trial on a 5-point Likert Scale (1-very unimportant to 5-very important). Mean scores and standard deviations were calculated for each statement and arranged in descending order to provide the final priority lists. Results: Thirty-six carers responded to the survey. Helping to create awareness about carers was the top ranked motivator, followed by four study design statements related to the time at which the study occurs, the study location, format of delivery and venue. The least important motivator related to how carers were invited to take part in a study. Difficulties in planning due to the caring role emerged as the most important challenge for carers, followed by being unable to leave the care recipient on his/her own. Conclusions: Insight into decision-making for research participation will assist trial developers tailor trial processes for informal caregiver populations. We recommend that trialists consider these motivators and challenges when designing future trials involving informal caregivers so as to enhance trial feasibility and success.