Mild cognitive impairment (MCI) Mental and Behavioural Disorders
Conditions
Interventions
Participants will use a virtual reality (VR) tool designed for cognitive assessment and wellbeing. Assessments will include questionnaires and cognitive tests.
Sub-study 1 (interventional
pre–post, three groups
quasi-controls):
Participants will use rehabilitation technologies with and without nudge strategies to determine their effectiveness in technology acceptance and intervention enhancement. Data will b
participants are assigned to groups pragmatically by centre scheduling and feasibility. No blinding is planned.
Sub-study 2 (prospective cohort
instrumental/diagnostic):
This is an instrumental study since it is aimed at examining the psychometric properties of a test for detecting the conversion of healthy individuals to mild cognitive impai
Sponsors
Fundación INTRAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Sub-study 1: 1. =60 years old 2. MMSE score between 20 and 30 3. Ability to understand and provide informed consent to participate in the study 4. Signed consent for participation and processing of study data (the transfer of collected data to a database is optional and does not imply exclusion from the study) 5. Expressed desire to receive support in relation to the use of technologies and/or willingness to participate in co-creation groups Sub-study 2: 1. =55 years old 2. MMSE score between 20 and 30 3. Ability to understand and provide informed consent to participate in the study 4. Signed consent for participation and processing of study data (the transfer of collected data to a database is optional and does not imply exclusion from the study) 5. Expressed desire to receive support in relation to: 5.1. Use of technologies 5.2. Mood 5.3. Cognitive stimulation
Exclusion criteria
Exclusion criteria: 1. Sensory difficulties that hinder the use of the device 2. Psychiatric conditions or neurological problems that prevent participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub-study 1: 1. Quality of life measured with EuroQol-5D (EQ-5D) at pre and post intervention 2. Health status measured with Short Form Health Survey (SF-12) at pre and post intervention 3. Perceived loneliness measured with UCLA Loneliness Scale (UCLA-LS) at pre and post intervention 4. Social connectedness measured with Lubben Social Network Scale (LSNS) pre and post intervention 5. Post-use satisfaction/usability measured with Post-Study Usability Questionnaire (PSSUQ) at post intervention 6. Perceived usability measured with System Usability Scale (SUS) at post intervention 7. Technology acceptance/intention to use measured with Unified Theory of Acceptance and Use of Technology (UTAUT/UTAUT2) at post intervention 8. Depressive symptoms measured with Geriatric Depression Scale (GDS; Yesavage) or Beck Depression Inventory-II (BDI-II) at pre and post intervention Sub-study 2: 1. Clinical severity / conversion status measured with CDR–Sum of Boxes (CDR-SB) at baseline, 12 months, 24 months 2. Cognitive reserve measured with Cognitive Reserve Index Questionnaire (CRIq) at baseline 3. Subjective memory complaints measured with Subjective Memory Complaints Questionnaire (SMCQ/CMS) at baseline, 12 months, 24 months 4. Mood measured with Geriatric Depression Scale (GDS, short form) or Beck Depression Inventory (BDI-II) at baseline, 12 months, 24 months 5. Episodic memory measured with TAVEC Verbal Learning Test at baseline, 12 months, 24 months 6. Attention and executive control measured with Stroop Test at baseline, 12 months, 24 months 7. Visuoconstruction measured with Rey–Osterrieth Complex Figure at baseline, 12 months, 24 months 8. Visuospatial working memory measured with Corsi Block-Tapping at baseline, 12 months, 24 months 9. GRADIOR DLA PREVENTION VR subtests (memory, executive functions, spatial navigation) at baseline, 12 months, 24 months 10. Usability assessed with System Usability Scale (SUS) at baseline, 12 months, 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Sub-study 1: 1. Multimorbidity burden measured with Cumulative Illness Rating Scale (CIRS) at pre and post intervention 2. Dementia risk profile measured with Cardiovascular Risk Factors, Ageing, and Dementia Scale (CAIDE) at pre and post Intervention 3. Alcohol use risk measured with Alcohol Use Disorders Identification Test (AUDIT) at pre and post Intervention 4. Physical activity measured with International Physical Activity Questionnaire (IPAQ) at pre and post Intervention 5. Global cognition measured with Mini-Mental State Examination (MMSE) at pre and post intervention 6. Clinical staging measured with Clinical Dementia Rating (CDR) (global) at pre and post intervention 7. Basic ADLs measured with Katz Index of Activities of Daily Living (ADL) at pre and post intervention 8. Instrumental ADLs measured with Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at pre and post intervention 9. Cognitive reserve measured with Cognitive Reserve Index Questionnaire (CRIq) pre intervention 10.Subjective cognitive complaints measured with Subjective Memory Complaints Questionnaire (SMCQ/CMS) at pre and post intervention Sub-study 2: 1. Multimorbidity burden measured with Cumulative Illness Rating Scale (CIRS) at baseline, 12 months, 24 months 2. Dementia risk profile measured with Cardiovascular Risk Factors, Ageing, and Dementia Scale (CAIDE) at baseline, 12 months, 24 months 3. Alcohol use risk measured with Alcohol Use Disorders Identification Test (self-administered version) (AUDIT) at baseline, 12 months, 24 months 4. Physical activity measured with International Physical Activity Questionnaire (IPAQ) at baseline, 12 months, 24 months 5. Global cognition measured with Mini Mental State Examination (MMSE) at baseline, 12 months, 24 months 6.Quality of life measured with EuroQol-5D (EQ-5D) at pre and post intervention at baseline, 12 months, 24 months | — |
Countries
Spain
Contacts
Public ContactRaquel Losada Duran
Outcome results
None listed