Effects of the tailored activity program (TAP) on dementia-related symptoms, health events and caregiver wellbeing: a randomized controlled trial

Abstract

Background People living with dementia (PLWD) and caregivers are adversely impacted by lack of meaningful activity leading to worse symptoms and impaired quality-of-life. There is a critical need to develop effective and well-tolerated treatments that mitigate clinical symptoms, engage PLWD and support caregiver wellbeing. We tested whether, compared to attention control, the Tailored Activity Program (TAP) reduced clinical symptoms and health-related events, and improved caregiver wellbeing, and if TAP activities were well-tolerated. Methods We conducted a single-blind randomized controlled trial among 250 dyads recruited from Baltimore-Washington DC (2012–2016) with a dementia diagnosis and clinically significant agitation/aggression. Dyads were randomized to TAP ( n \u2009=\u2009124) or attention control ( n \u2009=\u2009126), and interviewed at baseline, 3 (endpoint) and 6-months (follow-up) by interviewers masked to group allocation. TAP assessed PLWD abilities/interests, instructed caregivers in using prescribed activities, and provided dementia education and stress reduction techniques. Attention controls received disease education and home safety tips. Both groups had up to 8 home visits over 3-months. The primary outcome was frequency by severity scores for agitation/aggression subscales of Neuropsychiatric Inventory-Clinician using caregiver ratings. Secondary outcomes included number of instrumental (IADL) and activities of daily living (ADL) needing assistance, caregiver wellbeing, and confidence using activities. Health-related events (PLWD death, hospitalizations, caregiver hospitalization, depression) and perceived study benefits were captured over 6 months. PLWD tolerability of prescribed activities was examined. Results Of 250 dyads, most caregivers were female (81.2\u2009%, n \u2009=\u2009203), non-spouses (54.4\u2009%, n \u2009=\u2009136), white (59.2\u2009%, n \u2009=\u2009145) or African American (36.7\u2009%, n \u2009=\u200990) with mean age\u2009=\u200965.4 (SD\u2009=\u200912.6). PLWD were mostly female (63.2\u2009%, n \u2009=\u2009158) with mean age\u2009=\u200981.4 (SD\u2009=\u20097.9), and mean MMSE\u2009=\u200914.3 (SD\u2009=\u20097.8). At 3-months, compared to controls, TAP conferred no benefit to agitation/aggression ( p \u2009=\u20090.43, d \u2009=\u20090.11), but resulted in less IADL ( p \u2009=\u20090.02, d =-0.33), and ADL ( p \u2009=\u20090.04, d =-0.30) assistance, improved caregiver wellbeing ( p \u2009=\u20090.01, d \u2009=\u20090.39), and confidence using activities ( p \u2009=\u20090.02, d \u2009=\u20090.32). By 6-months, 15 PLWD in TAP had\u2009 ≥ \u20091 health-related event versus 28 PLWD in control, demonstrating 48.8\u2009% improvement in TAP ( p \u2009=\u20090.03). TAP caregivers were more likely to perceive study benefits. Prescribed activities were well-tolerated. Conclusions Although TAP did not benefit agitation/aggression, it impacted important outcomes that matter to families warranting its use in dementia care. Clinical trial registration Clinicaltrials.gov # NCT01892579 at https://clinicaltrials.gov/ ; Date\xa0of clinical trial registration: 04/07/2013; Date first dyad enrolled: 15/11/2013.