MinderCare: protocol for a mixed-methods evaluation of a digitally enabled dementia care service
Dementia
Current interventions as of 30/07/2026: Interventions MinderCare is a digitally enabled dementia care model that combines passive in-home monitoring with monitoring team review and nurse-led clinical triage to support proactive care for people living with confirmed or suspected dementia at home. The study will evaluate the performance of MinderCare digital biomarkers, the feasibility and acceptability of delivering the service within routine NHS and social care pathways, participant and carer outcomes, healthcare utilisation, and health-economic impact. The main prospective cohort will include 100 people living with confirmed or suspected dementia. This sample size is expected to provide sufficient alert-level and participant-level observations to estimate key digital biomarker performance metrics with accompanying 95% confidence intervals across a range of clinical and behavioural outcomes, informed by previous experience from related Minder studies. Where available, study partners will also be invited to participate in assessments and follow-up. A comparative-effectiveness component will use linked electronic health record data to construct an electronically matched external usual care control cohort, using a target trial emulation framework. Following expression of interest, eligibility and capacity to participate will be assessed before enrolment. Capacity will be assessed on an ongoing basis throughout the study. Written informed consent will be obtained from participants who have capacity. For participants who lack capacity, advice will be sought from a personal or nominated consultee in accordance with applicable UK guidance. Where a study partner is involved, written informed consent will also be obtained from the study partner. After enrolment, passive sensors will be installed in the participant’s home by the MinderCare monitoring team. The sensor configuration will be tailored to the participant’s home environment and preferences and may include a slee
Current inclusion criteria as of 30/07/2026: Participants are eligible if they: 1. Have a confirmed or suspected diagnosis of dementia of any subtype 2. Are aged 50 years or older at baseline 3. Live at home in the community 4. Are able to provide informed consent or, if they lack capacity, have a personal or nominated consultee available Where a study partner is involved, the study partner must be aged 18 years or older and willing and able to provide informed consent. The absence of a study partner is not an exclusion criterion. The study is intended to include people who live alone or are socially isolated. Potential participants who do not fully understand spoken or written English may be included with translation or interpreter support, provided that consent or consultee procedures can be completed appropriately and study procedures can be delivered safely. Previous inclusion criteria: Participants must meet the following criteria for study entry: 1. Confirmed or suspected diagnosis of dementia (any type), male or female, 50 years of age and older at baseline. Suspected dementia will be verified as follows: 1.1. Within a hospital clinic letter or discharge report written by the medical team referring to ‘suspected dementia’ or cognitive decline with/without a recent episode of delirium (ICD 10 F05 Delirium) and recommendation for referral to Memory Services diagnostic clinic 1.2. Patients prescribed with the following: cholinesterase inhibitors without a corresponding diagnosis of Alzheimer’s disease or dementia; donepezil; rivastigmine; galantamine; memantine. 2. Participants who lack the capacity to provide informed consent must have a personal or nominated consultee representative. Where a potential study partner is available, they must meet the following criteria: 1. Willing and able to provide informed consent to be in the study. 2. Aged 18 years or over The absence of a study partner will not constitute an exclusion criterion as we are keen to make
Current exclusion criteria as of 30/07/2026: Participants are excluded if they: 1. Have unstable comorbid mental illness requiring secondary mental health care at screening or baseline, including active psychosis or substance misuse 2. Have active suicidal ideation 3. Are receiving treatment for a terminal illness or are under palliative care at screening or baseline 4. Lack capacity and do not have a personal or nominated consultee Where a study partner is involved, they are excluded only if they are unable to participate in study procedures, including communication required for consent and follow-up, or are unable to provide written informed consent. Health and social care professionals will be excluded if they are unwilling or unable to provide written informed consent or unable to participate in relevant study procedures, including surveys, interviews, or focus groups. Previous exclusion criteria: The following are the exclusion criteria for the participant: 1. People with co-morbid unstable mental illness, for example, active psychosis/substance misuse under the care of CMHT at screening and baseline. 2. People who currently have active suicidal ideas. 3. People who are receiving treatment for terminal illness at screening and baseline or under the care of a palliative care team. Where a potential study partner is available, the following are the exclusion criteria for the study partner: 1. People who are unable to communicate verbally. 2. People who are unable to provide written informed consent to be part of the study. Professionals and members of the public sample for PPIE activities: 1. Unwilling to provide written informed consent