Gitlin 2018.

Study characteristics
Methods	Randomised controlled trial, registration number: NCT01357564 (prospectively registered) Duration of follow‐up: 4 months (primary analyses), last follow‐up: 8 months Recruitment period: 2012 to 2015, no further information about the study period reported
Participants	Country: USA Participants were recruited using geriatric Veteran Affairs (VA) services. Inclusion criteria: participants with dementia: English‐speaking, MMSE score of 23 or less or a physician diagnosis of dementia, able to participate in 2 or more self‐care activities, not involved in other studies. In case of taking any psychotropic medications (from the following classes: antidepressant, benzodiazepine, antipsychotic, anticonvulsant) or an antidementia medication (memantine, cholinesterase inhibitor), the dose had to be stable 60 days before enrolment. Caregivers: English‐speaking, primary caregivers ≥ 21 and living with the veteran, accessible by telephone, planned to live in the region for 8 months, willing to learn activities, had managed 1 or more behavioural symptoms in the past month, not involved in other studies. If caregivers were taking psychotropic medications, the dose had to be stable 60 days before enrolment. Number of participants completing the study: after 4 months (primary analysis): n = 111 (intervention group n = 51, control group n = 60); n = 160 participants (intervention group n = 76, control group n = 84) were included in the analysis (using data imputation) Age (mean ± SD) years: participants with dementia: 80.4 ± 8.7; caregivers: 72.4 ± 10.6 Gender, female: participants with dementia: 3.1%; caregivers: 97.5% Cognitive status MMSE (mean ± SD): participants with dementia: intervention group 16.8 ± 7.6, control group 16.4 ± 8 Care dependency, number of ADLs needing assistance with (mean ± SD) (range 0 to 7): intervention group 3.2 ± 2.6, control group 2.9 ± 2.5 Relationship to the participant (spouse): 86.9%
Interventions	Intervention: Tailored Activity Program – Veterans Administration (TAP‐VA) Control: attention control group (telephone‐based dementia education sessions)
Outcomes	Primary: number of behaviours (Neuropsychiatric Inventory‐Clinician (NPI‐C)) after 4 months Secondary: frequency of behaviours (NPI‐C) multiplied by severity of occurrence, functional dependence, pain, emotional well‐being, caregiver burden, caregiver affect, adverse events
Funding	Veterans Administration Health Services Research and Development Service (VA‐IIR 11–119).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization lists and two sets of randomization forms were prepared using opaque envelopes". Participating caregivers were "stratified according to caregiver relationship to the veteran (spouse vs nonspouse)".
Allocation concealment (selection bias)	Low risk	"The project statistician provides the necessary materials and randomization list to a research staff member who is not involved in study oversight, intervention, or interview. This individual prepares consecutively numbered randomization envelopes which contains the group allocation information on a piece of paper folded over multiple times to obscure the information, and provides the envelopes to the project coordinator. The project coordinator then randomized a subject by opening the next available envelope for the appropriate stratum (spouse/ non‐spouse)." (Gitlin 2013)
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	Unclear risk	"By 4 months, 111 (69.4%) dyads were available (51 = TAP; 60 = controls), and 49 (31.2%) were unavailable (25 = TAP; 24 = controls). There were statistically significant differences at baseline between completer and noncompleter caregivers at 4 months. Noncompleters cared for veterans with more functional dependence, behavioral symptoms, financial strain, caregiver burden, and caregiving hours than completers (all P’s<.05). Noncompleters were more likely to care for older (P = .09) and non‐Hispanic (P = .10) veterans." Comment: attrition rates did not differ strongly between groups (intervention group approximately 33%, control group approximately 30%). Reasons reported for all dropouts, and seem not to be related to the intervention.
Selective reporting (reporting bias)	Low risk	All planned outcomes reported.
Other bias	Low risk