MinderCare: translational research and digitally enabled care

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

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 is completed at baseline and every 6 months, as well as at withdrawal or study exit. Optional participant and/or study partner interviews are conducted approximately 2 months after installation and again at 6 months or de-installation/study exit. Health and social care professional surveys, focus groups, and follow-up interviews are conducted during study implementation and follow-up.
9. Feasibility, acceptability, reach, retention, implementation, sustainability, and operational workload of the MinderCare service assessed using recruitment and retention data, screening logs, contact logs, clinical review records, technical support logs, and qualitative interviews or focus groups. Recruitment, screening, retention, contact, clinical review, and technical support data are collected throughout recruitment and study participation. Qualitative interviews with participants and/or study partners are conducted approximately 2 months after installation and again at 6 months or de-installation/study exit; health and social care professional surveys, focus groups, and follow-up interviews are conducted during study implementation and follow-up.
10. System reliability, accessibility, and technical performance assessed throughout study participation using device connectivity data, Wi-Fi availability, need for study-provided routers, device reliability, technical failures, system downtime, data completeness, missingness, and reasons for non-enrolment or withdrawal. These data are collected continuously throughout active monitoring from sensor activation until withdrawal or study exit.
11. Alert and clinical workflow outcomes, including alert burden per participant, alert burden per 100 participants, alert distribution, redundant alert ratio, time from alert to review, clinical response ratio by response pathway, time from alert to action, and serious missed events where identifiable. These data are collected continuously throughout active monitoring from sensor activation until withdrawal or study exit.
12. Health-economic outcomes measured using linked health and care records, including secondary care costs, primary care costs, prescribing and medication costs, total direct healthcare costs, social care costs where data are available and of sufficient quality, and projected budget impact of wider implementation. Routine linked health and care record data will be extracted during or after study follow-up for the relevant follow-up period.

Previous secondary outcomes:
1. Healthcare usage, clinical events, transitions in care, and mortality rate measured via access to healthcare records and information obtained through planned and unplanned well-being calls during study participation
2. Health-related metrics measured using the Dementia Proforma and Client Service Receipt Inventory (CSRI) at baseline, 6 months, and 12 months (if applicable)
3. Activities of daily living measured using the Bristol Activity of Daily Living (BADL) scale at baseline, 6 months, and 12 months (if applicable)
4. Quality of life measured using the EuroQol-5D (EQ-5D) and Adult Carer Quality of Life Questionnaire ACQoL scales at baseline, 6 months, and 12 months (if applicable)
5. Neuropsychiatric symptoms assessed using the Neuropsychiatric Inventory–Questionnaire (NPI-Q) at baseline, 6 months, and 12 months (if applicable)
6. Depression evaluated using the Patient Health Questionnaire (PHQ-9) at baseline, 6 months, and 12 months (if applicable).
7. Cognitive functions assessed using Addenbrooke's Cognitive Examination III (ACE III) at baseline, 6 months, and 12 months (if applicable)
8. Anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) scale at baseline, 6 months, and 12 months (if applicable)
9. System usability evaluated using the System Usability Scale (SUS) at baseline, 6 months, and 12 months (if applicable).
10. System reliability, accessibility, and acceptability assessed throughout study participation:
10.1. System reliability evaluated based on the nature and frequency of technical and human factor issues (e.g., devices being moved or unplugged)
10.2. System accessibility evaluated by tracking the number of participants who lack Wi-Fi at enrollment and require SIM-enabled routers to participate
10.3. System acceptability measured based on reasons for non-enrollment (via the screening log) and SUS scores.
11. System acceptance and usability by healthcare/social care professionals assessed using the Technology Acceptance Model (TAM) at baseline (professional group).
12. Participants' and healthcare professionals' experiences with system alerts, including utility, acceptability, accessibility, and service satisfaction, assessed via interviews/focus groups /PPIE (Patient and Public Involvement and Engagement) activities throughout the study duration.