The Feasibility of Recruiting People with Advanced Dementia into Research

Aim: It can be challenging recruiting frail older people with advanced disease to research studies. We aimed to test a method of recruiting seriously ill patients with advanced dementia during acute medical hospital admission. Design: Longitudinal cohort study of pain and behavioural symptoms in people with dementia. Method: The research took place in 2 large hospitals in the United Kingdom (UK). All patients aged ≥70 years with unplanned acute medical admission and a diagnosis of dementia DSMIV with sufficient English language to complete study ratings were eligible. Dementia severity was assessed using the Functional Assessment Staging Scale (FAST); 1-5=mild, 6=moderate, 7 and above=advanced. Researchers assessed patients’ capacity to give informed consent within 72hrs of admission. For patients without capacity their main carer was approached to give assent. In accordance with the Mental Capacity Act (MCA) 2005, a professional consultee was asked to give their opinion when carers were not available. Findings: 1162 potential participants were identified, 1382 not eligible. 230 patients recruited, 66% female, mean age 87 (range 75-101). Twenty nine patients (22%) had capacity to consent, of these 90 % had mild and 10% moderate dementia. No patient with advanced dementia had capacity to consent. Carers gave assent for 189 patients, of these 29% had mild, 55% moderate and 16% advanced dementia. Professional consultee’s opinion was required for 12 patients, 50% mild, 42% moderate and 8% advanced dementia. Conclusions: Previous and current research has reported that studying disease trajectory and symptoms in people with advanced dementia is a complex and difficult process. We used the Mental Capacity Act to recruit acutely ill older people with advanced dementia, in an acute setting with a limited timescale. This method reduces the risk of bias in this population and may be transferable to other advanced diseases where capacity to consent is impaired