Gitlin 2013.

Trial name or title	A non‐pharmacologic approach to address challenging behaviours of veterans with dementia: description of the tailored activity program‐VA randomised trial
Methods	Randomised controlled trial
Participants	Caregivers of people with dementia
Interventions	Title of intervention: Telephone attention control Aim: The telephone component of the study is the attention control and serves three purposes: 1) creates clinical equipoise, ensuring that ethical treatment is provided to all study participants; 2) controls for the one‐on‐one attention to caregivers in the Tailored Activity treatment group to rule out potential effects of professional contact; and 3) serves as a retention tool to keep control group caregivers meaningfully connected to the trial. Interventionist(s): Trained healthcare professional Mode of delivery: Telephone Duration: Sixteen weeks (biweekly telephone contact (up to 8 contacts), each contact is approximately 30 minutes in length) Content: In each session, caregivers are provided with important information about dementia and strategies for managing the disease at home. Each telephone contact begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Standardisation: Not stated Comparison group: The Tailored Activity Program – Veterans Administration (TAP‐VA) provides an assessment of the veterans home environment and provides caregivers with the requisite knowledge and skills to use activities. Caregivers are instructed in specific skills such as ways to simplify activities, the environment and their communication, and how to help the veteran initiate and follow a sequence. The overall goal is to provide predictability, familiarity, and structure in the daily life of the veteran and establish a level of environmental stimulation appropriate to that person’s abilities.
Outcomes	1. Burden: Zarit Short Form Burden Scale 2. Depression: The Center for Epidemiologic Studies Depression Scale (CES‐D) 3. Cost: Cost‐effectiveness is measured as the cost of achieving one additional unit of benefit as defined by caregiver hours per day “doing things” and hours per day “being on duty.”
Starting date	August 2012
Contact information	Laura N Gitlin, Johns Hopkins University, 525 N. Wolfe Street, Baltimore, MD 21205, USA Email: lgitlin1@jhu.edu
Notes	This is a protocol for a registered trial (ClinicalTrials.gov Identifier NCT01357564). The registered trial primary completion date was June 2016 with an estimated study completion date of August 2018. The ClinicalTrials.gov site indicates that the study is not yet recruiting.