Harmony at HOME (Help Online Modifying the Environment): Proof-of-concept clinical trial of an innovative telehealth intervention for adults with Alzheimer’s disease with behavioral symptoms

Background: Nearly 90% of adults diagnosed with Alzheimer’s disease and related dementias experience behavioral symptoms (e.g., agitation, depression, anxiety, apathy). Current pharmacological treatment options lack high efficacy and pose dangerous side effects. Innovative approaches are needed to enhance care for these symptoms. This study aimed to assess feasibility of Harmony at HOME (Help Online Modifying the Environment), a telehealth occupational therapy intervention for community-dwelling adults with Alzheimer’s disease exhibiting behavioral symptoms (ClinicalTrials.gov Identifier: NCT04555616). Method: Using a single-blind, three-arm, randomized controlled trial design, participants were enrolled into one of the following arms: 1) individualized intervention (I) with tailored training regarding sensory stimulation to facilitate adaptive behavior and functional performance; 2) standardized intervention (S) curriculum for care partner training; and a 3) control arm (C) receiving standard of care. Both intervention arms received sensory stimulation tool kits to facilitate behavioral regulation. All participants completed 6 telehealth visits, one per week, with an occupational therapist. The primary outcome of feasibility was measured by attendance to weekly visits, and secondary outcomes included change in patient performance in functional activity assessed via the Canadian Occupational Performance Measure and change in neuropsychiatric symptoms assessed via the Neuropsychiatric Inventory Questionnaire. Result: Thirty dyads (person with Alzheimer’s disease and their care partner) agreed to participation and were randomized. Analyses demonstrate the intervention is feasible with high adherence to weekly visits (I = 88%; S = 100%; C = 60%; p = 0.06) and high participant retention within the individualized arm (I = 80%; S = 60%; C = 50%; p-value = 0.14). While the study was not powered to compare secondary outcomes among groups, within group exploratory analyses show promise for the individualized intervention. Improvements were observed in patient performance (baseline x̄ = 4.3; post intervention x̄ = 6.6; p = 0.04; Cohen’s d = 1.0). The individualized intervention also shows promise in reduction of behavioral symptoms (baseline x̄ = 11.55; post intervention x̄ = 8.6; p-value = 0.06) and caregiver distress (baseline x̄ = 15.2; post intervention x̄ = 9.9; p-value = 0.03). Conclusion: This Stage 1 feasibility study identified that the Harmony at HOME intervention was feasible for community-dwelling adults with Alzheimer’s disease and behavioral symptoms. The intervention offers promise for improved patient performance in functional activities and behavioral symptoms with a long-term goal to prolong community residency for this population.