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) |
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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 |
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Interventions | Intervention: staff training designed to enable care home staff to provide personalised activities Control: usual care |
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Outcomes | Primary: Quality of Life (QOL‐AD, self‐ and caregiver‐rating) Secondary: challenging behaviour (CBS), depression (CSD), anxiety (RAID), number and type of medication |
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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 |