Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Reducing Agitation in People With Dementia: the Customized Activity Trial
Brief Summary: Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). A hallmark of the disease and one of the most significant challenges in dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and frequently occurring. It is associated with increased health care costs, reduced life quality, heightened caregiver burden, disease acceleration and nursing home placement. Treatment typically involves pharmacologic agents; however, these are at best modestly effective, carry serious risks including mortality, and may not reduce family distress. Recently issued position statements from medical organizations suggest nonpharmacologic strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation remain understudied. We propose a Phase III efficacy trial to test a novel 8-session patient-centric intervention, the Tailored Activity Program. We will test the program using a randomized two-group parallel design of 250 people with dementia (PwD) and their CGs (dyads) who will be randomly assigned to received a program of tailored activities or a control intervention of equivalent in-home attention and social contact. The trial assesses PwDs' preserved capabilities, deficits, previous roles, habits, interests and home environment from which activities are developed to match PwD profiles. Families are trained to implement activities and modify them for future decline. Our primary study aim evaluates the effect of tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored activity program will have less frequent agitation compared to the control intervention condition. Three secondary aims evaluate: 1) 6-month effects of tailored activities on agitation and quality of life in PwD (Hypothesis: PwD receiving tailored activities will manifest lower severity scores at 6 months and better quality of life compared to PwD in the control intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG wellbeing, and time spent providing care (Hypothesis: CGs receiving training in tailoring activities will report enhanced wellbeing and less time caregiving compared to the control intervention (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program expressed as an incremental cost outcome achieved in the form of CG burden reductions and willingness to pay for burden reductions (3 and 6 months; Hypothesis: Tailoring activities will be cost effective compared to the control intervention at each test occasion). Exploratory aims will evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if effects differ by cognitive status, if CGs receiving the tailored activity program will use activities at 6 months and with what frequency, how time gained is spent, and if frequency/duration of treatment and activity use affects outcomes. If proven efficacious and cost effective, the Tailored Activity Program has potential to transform clinical practice by offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial addresses a critical clinical need and public health priority identified by recent legislative activity.


Options:
A: Arm Label: Best practices primary care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Best practices primary care | Arm Label: Home based occupational therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Home based occupational therapy | Intervention Type: BEHAVIORAL; Name: Home based occupational therapy; Assigned to Arm(s): Home based occupational therapy | Intervention Type: BEHAVIORAL; Name: Best practices primary care; Assigned to Arm(s): Best practices primary care
B: Arm Label: Tailored Activity Program; Type: EXPERIMENTAL; Interventions: Behavioral: Tailored Activity Program | Arm Label: Home Safety and Education Program; Type: ACTIVE_COMPARATOR; Interventions: Other: Home Safety and Education Program | Intervention Type: BEHAVIORAL; Name: Tailored Activity Program; Assigned to Arm(s): Tailored Activity Program | Intervention Type: OTHER; Name: Home Safety and Education Program; Assigned to Arm(s): Home Safety and Education Program
C: Arm Label: Intensive Protocol; Type: EXPERIMENTAL; Interventions: Behavioral: STOMP (Skill-building through Task-Oriented Motor Practice) | Arm Label: Less-Intensive Protocol; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: STOMP (Skill-building through Task-Oriented Motor Practice) | Intervention Type: BEHAVIORAL; Name: STOMP (Skill-building through Task-Oriented Motor Practice); Assigned to Arm(s): Intensive Protocol, Less-Intensive Protocol
D: Arm Label: active tDCS plus real CT; Type: EXPERIMENTAL; Interventions: Device: active tDCS, Behavioral: real CT | Arm Label: sham tDCS plus real CT; Type: EXPERIMENTAL; Interventions: Device: sham tDCS, Behavioral: real CT | Arm Label: active tDCS plus placebo CT; Type: EXPERIMENTAL; Interventions: Device: active tDCS, Behavioral: placebo CT | Arm Label: sham tDCS plus placebo CT; Type: PLACEBO_COMPARATOR; Interventions: Device: sham tDCS, Behavioral: placebo CT | Intervention Type: DEVICE; Name: active tDCS; Assigned to Arm(s): active tDCS plus placebo CT, active tDCS plus real CT | Intervention Type: DEVICE; Name: sham tDCS; Assigned to Arm(s): sham tDCS plus placebo CT, sham tDCS plus real CT | Intervention Type: BEHAVIORAL; Name: real CT; Assigned to Arm(s): active tDCS plus real CT, sham tDCS plus real CT | Intervention Type: BEHAVIORAL; Name: placebo CT; Assigned to Arm(s): active tDCS plus placebo CT, sham tDCS plus placebo CT

Answer: B