Dementia, mild cognitive impairment, palliative care needs Mental and Behavioural Disorders
Conditions
Interventions
AI-powered digital educational module.
The study is conducted in two phases. In both phases, participation is fully voluntary, and all participants provide informed consent before starting.
In Phase
Sponsors
University Clinical Centre Maribor
Dom Nine Pokorn Grmovje
Centre for Gerontology and Rehabilitation, School of Medicine, UCC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase 1: Expert Participants 1. Clinical or academic expertise in dementia, palliative care, geriatrics, neurology, psychiatry, or related fields 2. Familiarity with digital health tools or willingness to use digital platforms for study participation 3. Ability to provide informed consent Phase 2: Patient Participants 1. Clinical diagnosis of dementia (early to mid-stage) or mild cognitive impairment, confirmed by a healthcare professional 2. Able to participate in supervised digital interactions with or without caregiver support 3. Capacity to provide informed consent 4. Stable medical condition allowing participation in non-invasive, educational interventions
Exclusion criteria
Exclusion criteria: Phase 1: Expert Participants: 1. Lack of direct experience with dementia or palliative care populations 2. Inability to use digital platforms required for the study 3. Current involvement in another conflicting research study Phase 2: Patient Participants: 1. Diagnosis of severe psychiatric or neurological disorders unrelated to dementia (e.g., schizophrenia, bipolar disorder, recent stroke) 2. Current participation in another clinical trial that may interfere with the study 3. Unstable or severe medical illness that would preclude safe participation 4. Non-study language speakers Phase 2: Family Caregiver Participants: 1. Active treatment for serious illness (e.g., cancer) that would limit participation 2. Participation in another caregiver intervention study that may confound results 3. Non-study language speakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Phase 1 Primary Outcome: AI Model Performance, assessed through expert ratings on a 1-5 Likert scale across four dimensions at a single timepoint: relevance, clarity, empathy, and actionability, with a target of achieving ratings =4 for clinical appropriateness Phase 2 Primary Outcome: User-Rated Relevance, assessed through patient and caregiver ratings on a 1-5 Likert scale at a single timepoint, with a target of achieving 80% relevance | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at a single timepoint: Phase 1 Secondary Outcomes: 1. Trustworthy Knowledge Base Creation - Development of an open, expert-validated, curated set of evidence-based, dementia-relevant educational sources published under a Creative Commons license. Sources are rated on trustworthiness using a 1-5 scale, with only resources achieving an average rating of =3.5 included in the knowledge base. 2. Expert System Usability - System Usability Scale (SUS) score of 70-100 from expert reviewers. This standardized questionnaire provides a single score from 0 to 100 reflecting the overall ease of use, learnability, and user satisfaction with the system. Phase 2 Secondary Outcomes: 1. Caregiver Usability Satisfaction - Caregiver satisfaction with system usability and usefulness as measured by a simplified System Usability Scale (SUS), with a target score of 70-100. 2. Patient Usability Satisfaction - Patient satisfaction with simplified system usability and usefulness as measured by a simplified System Usability Scale (SUS), with a target score of 70-100. 3. Query Cluster Identification - Identification of 3-5 dominant query clusters reflecting common information needs and search behaviors 4. Open Curated Dataset - Patient and caregiver relevant search patterns and responses published as an open curated dataset under Creative Commons license. | — |
Countries
Germany, Ireland, Portugal, Slovenia, Spain
Contacts
Public ContactIzidor;Suzanne Mlakar;Timmons
;
Outcome results
None listed