Methods: Stage 1B trials emphasize feasibility testing, refinement of intervention components, and identification of preliminary signals of efficacy in real-world settings. In this single-arm, non-randomized study, 40 caregiver–PLWD dyads residing in rural Appalachian communities were enrolled in a 6-week intervention designed to enhance caregiver capacity to manage BPSD through environmental modification and cueing strategies. The intervention integrates principles of person–environment fit, environmental press theory, and behavioral approaches. It was delivered via weekly telehealth sessions that emphasized individualized assessment, guided discovery, and skill-building within the home environment.
Results: The primary aim of this Stage 1B trial was to assess feasibility, operationalized through retention, engagement, and changes in caregiver mastery. Secondary outcomes included caregiver burden, perceived stress, caregiver appraisal, and BPSD, with exploratory outcomes assessing functional performance and caregiver satisfaction using the Canadian Occupational Performance Measure. Of the 40 dyads enrolled, 34 initiated the intervention, and 26 completed the full protocol (76% retention among initiators), supporting the feasibility of telehealth delivery in rural settings. While caregiver mastery demonstrated non-significant improvements, all caregiver-related outcomes trended in favorable directions. Importantly, statistically significant improvements were observed in PLWD functional performance (p < .005) and caregiver satisfaction with functional performance (p < .001), indicating meaningful gains in daily functioning and caregiving experience.
Conclusions and Implications: From an implementation science perspective, this Stage 1B trial advances a scalable, non-pharmacological approach that centers caregivers as active agents in shaping the care environment. By focusing on modifiable environmental factors and dyadic processes, Harmony at HOME aligns with social work values of person-in-environment practice and equity in access to care. Results suggest that caregiver mastery may be insufficiently sensitive to capture change in progressive conditions such as dementia, particularly in structurally constrained environments like rural Appalachia. Importantly, the telehealth delivery model demonstrates promise for reducing geographic barriers and extending evidence-based dementia care into underserved regions. The presentation will conclude with a discussion of how the findings have informed the current Stage 1B trial, @HOME+, which is refining the intervention.
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