MODEM: A Comprehensive Approach to Modelling Outcome and Costs Impacts of Interventions for Dementia, 2014-2018

In the MODEM cohort study, three-hundred and seven people with clinically diagnosed dementia and their carers were recruited on a quota basis to provide equal numbers of people with mild (standardised Mini-Mental State Examination (sMMSE), n = 110), moderate (sMMSE 10–19, n = 100), and severe (sMMSE 0–9, n = 97) cognitive impairment. Participants had a medical diagnosis of dementia made by a specialist mental health service. To be eligible the person with dementia needed to have an identifiable family (or friend) carer or other informant (e.g. a formal/professional carer). There were no exclusion criteria based on comorbidities, age, or type of dementia. The carer was required to self-identify themselves as a carer for the person with dementia. There were no other inclusion or exclusion criteria. Participants were recruited from memory services in Sussex, UK, or self-referral from a national electronic database (Join Dementia Research; https://www.joindementiaresearch.nihr.ac.uk/), community groups, and care homes in the South East of England. People with dementia and their carers were provided with information about the research and invited to participate in the study. A pair of researchers then visited the participants in their home (or another location convenient for the participant). The capacity of the person with dementia was formally assessed by a trained researcher. If the person with dementia did not have capacity to consent, a personal consultee (family member/friend) was identified to advise on whether the person with dementia should take part. For those with capacity, informed consent was obtained. The two researchers then completed a series of measures with the person with dementia and the carer in parallel. For the person with dementia, the following measures were collected: self-reported quality of life (DEMQOL, EQ-5D-3L, CASP-19); proxy-reported quality of life (DEMQOL-Proxy, EQ-5D-3L); severity of cognitive impairment (sMMSE, ADAS-COG); neuropsychiatric symptoms (NPI), depression (Cornell scale); activity limitation (BADLS, OARS); and comorbidities (CCI). Measures collected for the carer were: self-reported measures of quality of life (EQ-5D-3L, SF-12); social isolation (SIS); carer burden (ZCBI); and mental well-being (GHQ). Data were also collected on the use of services and level of help received by formal and unpaid carers and provided by the carer (CSRI) and demographic characteristics of the person with dementia and carer.