Gitlin 2008.

Study characteristics
Methods	Randomised controlled pilot study, registration number: NCT00259467 (retrospectively registered) Duration of follow‐up: 4 months Recruitment period: 2005 to 2006
Participants	Country: USA Participants were recruited via media announcements and social service mailings. Interested caregivers contacted the research office, were explained study procedures, and administered a telephone eligibility screening test. Inclusion criteria (participants): English‐speaking, a physician diagnosis or MMSE score < 24, able to feed self and participate in at least 2 self‐care activities (e.g. bathing, dressing) Exclusion criteria (participants): schizophrenia, bipolar disorder, or dementia secondary to head trauma, MMSE score 0, bed‐bound (confined to bed or chair), or non‐responsive (unable to understand short commands) Inclusion criteria (caregiver): English‐speaking, age ≥ 21 years, living with the participant, provides 4 h of daily care, report participant’s boredom, sadness, anxiety, agitation, restlessness, or trouble focusing on a task Exclusion criteria (caregiver): involvement in other studies, seeking nursing home placement, terminally ill, in active cancer treatment, or with 3 or more hospitalisations in the past year Number of participants completing the study: n = 56 (intervention group n = 27, control group n = 29) Age (mean ± SD) years: people with dementia: intervention group: 78.0 ± 9.2, control group: 80.8 ± 9.5; caregivers: intervention group 62.8 ± 11.3, control group: 67.9 ± 10.6 Gender (female): people with dementia: intervention group: 50.0%, control group: 36.7%; caregivers: intervention group: 83.3%, control group: 93.3% Cognitive status, MMSE (mean ± SD): intervention group 11.0 ± 7.3, control group 12.2 ± 8.8 Care dependency: Activities of daily living functioning (mean ± SD) (range 0 to 7): intervention group 4.6 ± 2.3, control group 4.37 ± 2.1 Relationship to the participant (spouse): intervention group 53.3%; control group 70.0%
Interventions	Intervention: TAP, selection of tailored activities, preparation of an activity plan, and caregiver training and support to deliver the planned activities Control: usual care
Outcomes	Primary: frequency of behaviour occurrence Secondary: person with dementia: number of behaviours occurring, depression, activity engagement, quality of life; caregiver: subjective burden, depression, activity mastery, confidence using activities, skill enhancement
Funding	National Institute of Mental Health (grant no. R21 MH069425)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"(...) dyads were randomized using random permuted blocks to control for possible changes in subject mix over time. The blocking number, developed by the project statistician, remained unknown to others."
Allocation concealment (selection bias)	Low risk	Not clearly stated. Information from study authors: allocation was performed by the project statistician and was concealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not blinded to group allocation (not possible). Insufficient information to permit judgement of ‘low risk’ or ‘high risk'
Blinding of outcome assessment (detection bias) Subjective outcomes (participant‐rated)	High risk	Caregiver outcomes: family caregivers were not blinded to group allocation
Blinding of outcome assessment (detection bias) Subjective outcomes (proxy‐rated)	High risk	Subjective outcomes, and assessors (family caregivers) were not blinded to group allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Of 60 dyads at baseline, four (7%) terminated because of patient death."
Selective reporting (reporting bias)	Unclear risk	All described outcomes reported, but the study was registered retrospectively, and no study protocol is available.
Other bias	Low risk