Dementia Nervous System Diseases
Conditions
Interventions
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
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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 the study as inclusive as possible. Professionals and members of the public sample for PPIE activities: 1. Adults (>= 18 years) 2. Willing to provide informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome as of 30/07/2026: The study has two primary outcome-measure domains: 1. Digital biomarker algorithm performance in the prospective MinderCare cohort will be measured against clinical ground-truth data using alert-level and event-level metrics, including sensitivity, specificity, positive predictive value, negative predictive value, false-alert rate, area under the ROC curve, timeliness of detection, and time from alert to clinical action 2. Days Alive and Out of Hospital (DAOH) in the comparative-effectiveness target trial emulation will be measured over 12 months from the activation-index date and compared between activated MinderCare plus usual care and electronically matched usual-care controls Previous primary outcome: Performance of algorithms measured based on the accuracy of alerts throughout the participation in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 30/07/2026: 1. Healthcare utilisation, clinical events, care transitions, institutionalisation, and mortality measured during study participation and, where applicable, over 12 months from the activation-index date using linked electronic health records, population health datasets, and information obtained through planned and unplanned clinical contacts. Healthcare utilisation outcomes include GP consultations, emergency department attendances, hospital admissions, inpatient bed-days, outpatient appointments, ambulance calls where available, and cause-specific hospitalisations. 2. Participant clinical status and health-related characteristics measured using the Dementia Proforma and Client Service Receipt Inventory (CSRI) at baseline and every 6 months, as well as at withdrawal or study exit. 3. Cognitive function measured using Addenbrooke’s Cognitive Examination III (ACE-III) at baseline and every 6 months, as well as at withdrawal or study exit. 4. Activities of daily living measured using the Bristol Activities of Daily Living Scale (BADL) at baseline and every 6 months, as well as at withdrawal or study exit. 5. Neuropsychiatric symptoms measured using the Neuropsychiatric Inventory Questionnaire (NPI-Q) at baseline and every 6 months, as well as at withdrawal or study exit. 6. Participant and carer quality of life measured using the EuroQol-5D (EQ-5D) and Adult Carer Quality of Life Questionnaire (ACQoL) at baseline and every 6 months, as well as at withdrawal or study exit. 7. Depression and anxiety measured using the Patient Health Questionnaire-9 (PHQ-9) and Generalised Anxiety Disorder-7 (GAD-7) at baseline and every 6 months, as well as at withdrawal or study exit. 8. System usability, user satisfaction, perceived ease of use, and intention to use measured using the System Usability Scale (SUS), surveys, interviews, and focus groups with participants, study partners, and health and social care professionals. The SUS | — |
Countries
England, United Kingdom
Outcome results
None listed