AbstractBackgroundIndividuals with Alzheimer’s dementia (AD) often go through a period of significant behavioral and psychological symptoms including agitation. This can lead to impaired daily functioning, prolongation of hospitalization, early institutionalization, and higher mortality. The integration of biomedical data acquisition systems and information technology enables continuous real‐time monitoring of physiological data in daily life.MethodThis feasibility study is part of a clinical trial that examines the effects of THC‐free CBD oil on agitation in patients with AD (NCT04436081), involves caregiver/care‐recipient dyads and the use of technology to capture agitation during a 14‐week period. Participants are given 2 Fitbit versa 2 (each includes a 3‐axis accelerometer and an optical heart rate monitor), a smartphone, a tablet, and a digital timer. Participants’ Fitbit are paired with their smartphone, while the caregivers’ FitBit is paired with their tablet. Participants include males/females over 50 years old, with the diagnosis of AD, a MMSE score ≤28 & ≥4, and agitation measured with an NPI agitation/aggression subscore >3. Each dyad completes 24 forms/questionnaires throughout the study electronically via provided apps. Caregivers are instructed to send a real time electronic alert when agitation episodes happen.ResultSo far, we have enrolled 26 dyads. For this report we have collected data on 22 participants with 140 million data points for limb movement and heart rate, and 969 nights of sleep data records. Overall compliance with wearable use was 77% of the time, with 82% in 11 participants, 65% in 8 participants and 32% in 3 participants. Compliance with electronic form/questionnaire completion was 87%. Electronic alert for agitation episodes were recorded by the caregivers only 50% of time.ConclusionThis study explores the feasibility and acceptability of using technology (wearables, electronic form data completion and submission, sleep, and real time agitation episode collection) for a 16‐week period in AD patients with agitation and their caregivers. We found high acceptability of wearing the Fitbit by AD patients with agitation. The primary issues interfering with data collection and device compliance were device battery life and memory, remembering to wear the device after charging, and technical fault in capturing the data.
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