| Protocol ID | NCT06888986 |
| Registration Date | 2025-03-21 |
| Status | completed |
| Sponsor | National Taiwan Normal University |
| Country | Taiwan |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2024-09-30 |
| Last Patient Out | 2025-08-10 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 65 Years - |
NCT06888986
Integration of VR, AR, AI and Wearable Technology to Develop Innovative Health Education and Monitoring Systems on Symptom Management, Situational Reaction, Learinging Process and Physical and Psychological Health of Early Dementia
| Field |
GLM
glm-5.1 8188ms / 9335 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5046ms / 10691 tok |
OPENAI
gpt-4o Thinking: o3 3351ms / 9193 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | cognitive impaired | cognitive impaired | cognitive impaired | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial utilizes physical wearable hardware, specifically VR headsets and hand controllers, to deliver the virtual reality intervention.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study involves VR headsets as physical hardware devices that participants wear and interact with during the intervention sessions.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study involves participants using VR headsets, which are physical devices, for the VR-based cognitive health education program.
|
OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study assesses dementia knowledge, health literacy, self-efficacy, and attitudes, but does not use any validated Quality of Life instruments such as the EQ-5D, SF-36, or WHOQOL.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study focuses on dementia-related knowledge, health literacy, self-efficacy, and attitudes toward dementia using specific scales (DKAS, DHLS, DSES, DAS), but does not employ validated quality of life instruments like EORTC QLQ-C30, FACT-G, EQ-5D, or SF-36.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial focuses on dementia-related knowledge, health literacy, self-efficacy, and attitudes but does not use validated Quality of Life instruments like EORTC QLQ-C30 or SF-36.
|
OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial measures knowledge/skills outcomes (dementia-related knowledge, health literacy, self-efficacy, and attitudes) which fall under the 'knowledge/skills' category rather than symptom/QoL/dignity/cost.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes measure knowledge, health literacy, self-efficacy, and attitudes which are educational/psychological measures that fall under quality of life and psychological well-being categories.
Thinking: yes — The trial measures dementia-related knowledge and health literacy, which are knowledge/skills outcomes not covered by symptom/QoL/dignity/cost categories.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial includes outcomes such as cognitive health knowledge and health literacy, which relate to knowledge/skills improvement outside symptom/QoL/dignity/cost categories.
Thinking: yes — Primary outcomes focus on knowledge, health literacy and self-efficacy, which are knowledge/skill outcomes outside symptom, quality-of-life, dignity or cost domains.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |