ISRCTN93568533.

Trial name or title	A study into the effects of activities with animals on the well‐being of Dutch nursing home patients with dementia
Methods	Single‐centre RCT (Netherlands)
Participants	People with dementia living in De Zorgboog, a large Dutch nursing home
Interventions	Nursing home clients randomised via computer‐generated random numbers to 3 groups. Group 1: dog‐assisted activity group sessions with handler. Group 2: robot‐assisted activity group sessions with handler (FurReal Friend robot). Group 3: control: group sessions with a visiting student Each participant will participate in 1 intervention session per week. All sessions will be videotaped for the entire duration of the study (8 weeks). Videos will be analysed after the intervention period using video‐coding to calculate the amount of social interactions and neuropsychiatric symptoms displayed during the sessions. Total duration: 8 weeks Follow‐up: 4 weeks
Outcomes	Primary outcomes: Social interaction during sessions Neuropsychiatric symptoms during sessions Secondary outcomes: Questionnaires will be used to measure several secondary outcomes at all or a subset of the following time points: baseline (t0), after 4 weeks (t1, halfway), after 8 weeks (t2, at the end of the intervention period), after 12 weeks (t3, 4 weeks postintervention follow‐up): Quality of life, measured using QUALIDEM at t0, t1, t2, t3 Depression, measured using CSDD at t0, t1, t2, t3 Neuropsychiatric symptoms, measured using NPI‐Q at t0, t1, t2, t3 Agitation, measured using CMAI at t0, t1, t2, t3 Medication usage, measured using medical records at t0, t2 Intercurrent diseases, measured using medical records at t0, t2 Dementia stage, measured using CDR at t0, t2 Functional state, measured using IDDD at t0, t2 Dementia, assessed using GIP, general dementia assessment tool, Dutch at t0, t2
Starting date	1 September 2014
Contact information	Ms Lonneke Schuurmans, Postalnr: 5330, Postbus 16, Bakel 5760 AA, Netherlands
Notes	No results posted in the study registry record.