🧫 Experiment Protocol
Clinicaldementia with behavioral and psychological symptomshuman patientsproposed
This single-blinded randomized controlled trial evaluated the effectiveness of a caregiver-initiated, multimodal mobile app delivering individualized nonpharmacological interventions (music therapy, exercise, reminiscence therapy) for reducing behavioral and psychological symptoms of dementia (BPSD). The intervention was tailored based on each user's preferences and functional abilities. Participants were 36 dyads comprising community-dwelling persons with dementia aged 60+ years and their primary family caregivers, recruited from outpatient clinics, dementia care centers, and home care service centers. The intervention group used the mobile app for 4 weeks while the control group received usual care. Primary outcomes included overall BPSD, agitated behavior, and depression, with secondary outcomes of nighttime sleep efficiency and caregiver competency. Assessments were conducted at baseline, immediately post-intervention, and at 2-week follow-up.
PRIMARY OUTCOME
overall BPSD, agitated behavior, and depression scores
EXPECTED OUTCOMES
1. The intervention targeting the nominated disease mechanism shifts overall BPSD, agitated behavior, and depression scores in the predicted direction relative to the matched control arm.
2. Secondary disease-relevant readouts in dementia with behavioral and psychological symptoms remain directionally concordant with the primary endpoint rather than showing isolated single-assay effects.
3. The effect persists after adjustment for baseline covariates, batch effects, or repeated-measures structure used in the study design.
SUCCESS CRITERIA
- Prespecified primary endpoint (overall BPSD, agitated behavior, and depression scores) improves versus control with p < 0.05 or an equivalent corrected threshold used by the study.
- The effect size is biologically meaningful and reproduced across technical/biological replicates or the validation subset.
- Safety, data quality, and missingness remain within protocol-defined bounds so the result is interpretable rather than driven by attrition or assay failure.
PROTOCOL
Single-blinded randomized controlled trial with 36 dyads randomized to intervention (mobile app for 4 weeks) or control (usual care). Multimodal app delivered individualized nonpharmacological interventions including music therapy, exercise, and reminiscence therapy based on user preferences and functional abilities. Assessments at baseline, post-intervention, and 2-week follow-up using validated BPSD measures.