Research AppraisalRandomised Controlled Trial

A Mobile App-Based Individualized Nonpharmacological Intervention for Behavioral and Psychological Symptoms in Dementia: Pilot Randomized Controlled Trial

JMIR mHealth and uHealthCho, Eunhee, Yang, Minhee, Hwang, Sinwoo et al.7 Apr 2026DOI

Clinical Snapshot

60CEBM
Evidence: WeakRandomised Controlled Trial

PICO Framework

P — PopulationCommunity-dwelling persons with dementia aged ≥60 years and their primary family caregivers (n=36 dyads)
I — InterventionCaregiver-initiated, multimodal mobile app delivering individualized nonpharmacological interventions (music therapy, exercise, reminiscence therapy) for 4 weeks
C — ComparatorUsual care
O — OutcomesPrimary: overall BPSD, agitated behavior, depression. Secondary: nighttime sleep efficiency, caregiver competency in managing BPSD

Bottom Line

This pilot RCT of a mobile app delivering individualised nonpharmacological interventions for dementia-related behavioural symptoms showed no significant benefits in the overall sample of 33 community-dwelling dyads. However, exploratory subgroup analysis suggested potential benefits for those with clinically significant baseline symptoms. While the digital approach addresses important access barriers to nonpharmacological interventions, the limited efficacy, small sample size, and methodological limitations (single-blind design, short duration) restrict clinical confidence. The intervention may warrant further investigation in larger, adequately powered trials focusing on patients with more severe baseline symptoms. Clinicians should continue recommending established nonpharmacological approaches while awaiting stronger evidence for digital interventions. The study highlights the challenges of translating promising digital health concepts into clinically meaningful outcomes for complex conditions like dementia.

Evidence: Weak

Key Findings

  • P Value: P=0.03 for subgroup analysis

  • Effect Size: Subgroup with clinically significant baseline BPSD: β=-12.885 for overall BPSD improvement

  • Primary Outcome: No significant group-by-time interaction effects for overall BPSD, agitated behavior, or depression in total sample

  • Nnt Or Sensitivity: Not calculable from available data due to non-significant primary outcomes

  • Confidence Interval: 95% CI -24.530 to -1.240

Clinical Application

Requires smartphone/tablet access and caregiver digital literacy; may face implementation barriers in older caregiver populations Relevant to Australian aged care policy emphasising home-based care; could complement existing RACGP dementia guidelines and support PBS-funded community services Community-dwelling persons with dementia and family caregivers, particularly those with clinically significant BPSD

Abstract

BACKGROUND: Behavioral and psychological symptoms of dementia (BPSD) are common and negatively impact both individuals with dementia and their families. Although nonpharmacological interventions are recommended as the first-line treatments, their use in community settings is limited by access and caregiver resources. Existing approaches are often not individualized and rely on institutional or clinician-led delivery. OBJECTIVE: We developed a caregiver-initiated and individualized multimodal mobile app. The app delivers tailored nonpharmacological interventions-such as music therapy, exercise, and reminiscence therapy-based on each user's preferences and functional abilities. This study aimed to evaluate the effectiveness of this mobile app-based intervention in reducing BPSD in community-dwelling persons living with dementia. METHODS: This study used a single-blinded randomized controlled trial design. Participants were recruited from an outpatient clinic of a tertiary hospital, a dementia care center, and 5 home care service centers. A total of 36 dyads participated, each comprising a community-dwelling person living with dementia aged 60 years or older and their primary family caregiver. The dyads were randomly allocated to either the intervention or control group. The intervention group received a caregiver-initiated, multimodal, mobile app-based individualized intervention for 4 weeks, whereas the control group continued with usual care. The primary outcomes were overall BPSD, agitated behavior, and depression. The secondary outcomes were nighttime sleep efficiency and caregiver competency in managing BPSD. Assessments were conducted at baseline, immediately after the intervention, and at a 2-week follow-up. RESULTS: Of the 36 randomized dyads, 33 were included in the final analysis. Although the intervention group showed greater reductions in overall BPSD, agitated behavior, and depression after the intervention, no significant group-by-time interaction effects were observed in the total sample. In the subgroup analysis of participants with clinically significant baseline BPSD, a statistically significant improvement in overall BPSD was found in favor of the intervention group (β=-12.885, 95% CI -24.530 to -1.240; P=.03). No significant effects were observed for either nighttime sleep efficiency or competence in the management of BPSD. CONCLUSIONS: A mobile app-based individualized intervention may offer a flexible, caregiver-initiated approach to managing BPSD in home-care settings. While overall effects were limited, exploratory subgroup findings provided meaningful insights, indicating potential benefits for those with higher baseline symptom severity. The results highlight the need for further research on adaptive personalization and optimized intervention delivery to enhance the clinical effectiveness of digital dementia care.

References

  1. 1.Cho, E., Yang, M., Hwang, S., Kim, E., Cho, J., & Kim, M. J. (2026). A Mobile App-Based Individualized Nonpharmacological Intervention for Behavioral and Psychological Symptoms in Dementia: Pilot Randomized Controlled Trial. JMIR mHealth and uHealth. https://doi.org/10.2196/79469
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