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. 2018 Feb 13;2018(2):CD009812. doi: 10.1002/14651858.CD009812.pub2

Wenborn 2013.

Methods Cluster‐randomised controlled trial, registration number: ISRCTN67952488
Duration of follow‐up: total of 28 weeks (16 weeks delivery of the intervention, 12 weeks' post‐intervention follow‐up)
Participants Country: UK (London)
Number of participants completed the study: n = 159 (intervention group n = 79, control group n = 80)
Number of clusters: 16 nursing homes (8 clusters per group)
Age (mean ± SD) years: intervention group 84.2 ± 7.6, control group 84.2 ± 7.6
Gender, female: intervention group 63.5%, control group 70.8%
Cognitive status, MMSE (mean ± SD): intervention group 5.8 ± 5.1, control group 5.5 ± 4.6
Care dependency, CAPE‐BRS (mean ± SD): intervention group 20.2 ± 4.3, control group 19.4 ± 4.6
Criteria for matching of clusters: provider (i.e. private company or statutory service or voluntary organisation), number of beds, registration category. For each participating organisation it was guaranteed to receive the intervention in at least 1 home
Inclusion criteria for clusters: sufficient staff available to attend the intervention programme (minimum of 3 per home), sufficient residents eligible for inclusion (double the number of staff designated to participate in the intervention)
Inclusion criteria: all residents ≥ 60 years, who had lived in the care home for at least 2 months and intending to stay, met the DSM‐IV criteria for dementia (American Psychiatric Association 1994) and had a MMSE score (Folstein 1975) less than 25
Exclusion criteria: residents with other serious physical or mental health problems
Interventions Intervention: staff training designed to enable care home staff to provide personalised activities
Control: usual care
Outcomes Primary: Quality of Life (QOL‐AD, self‐ and caregiver‐rating)
Secondary: challenging behaviour (CBS), depression (CSD), anxiety (RAID), number and type of medication
Funding North East London Mental Health NHS Trust ‒ Occupational Therapy service; UK
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Care homes were recruited as matched pairs (matched according to provider: statutory, private or voluntary organisation and size). In each pair, 1 care home was allocated to the interventions group and the other to the control group using a computer random number generator (published and unpublished information).
Allocation concealment (selection bias) Low risk Allocation was performed by a remote randomisation service (unpublished information).
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information reported. The nursing staff was trained to deliver the intervention; therefore blinding seems not possible.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes were assessed by the [primary investigator (before randomisation)] "at baseline and by blinded assessors at follow‐up."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Participants lost to follow‐up: n = 51; intervention group n = 25 (n = 17 died, n = 7 admitted to hospital, n = 1 moved), control group n = 26 (n = 23 died, n = 1 admitted to hospital, n = 2 moved).
Selective reporting (reporting bias) Unclear risk All outcomes reported, but the study was registered retrospectively and no study protocol is available.
Other bias Low risk