Carbone 2021.
Study characteristics | ||
Methods | RCT | |
Participants | N = 225 (149F/76M) 'Major neurocognitive disorder' DSM‐V mild‐to‐moderate range (no information regarding medication) Mean MMSE 20.1 (SD 4.0) Age 83.6 (SD 8.1; range 50‐99) 16 residential homes and day‐centres |
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Interventions | Cognitive stimulation groups (N = 123) Usual treatment group sessions (N = 102) |
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Outcomes | Cognition: ADAS‐Cog; MMSE Language: Narrative Language Test Quality of life: QoL‐AD (self‐report) Mood: Cornell Scale for Depression in Dementia ADL: Disability Assessment for Dementia (DAD) Behaviour problems: NPI |
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Notes | 45 minutes, twice a week, for 7 weeks; 3‐month follow‐up | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Covariate adaptive randomization was used at each participating centre". |
Allocation concealment (selection bias) | Unclear risk | No information provided as to who carried out the randomisation or the process used for concealment of allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Conducted by trained psychologists who did not participate in the treatment program, and they had no information on participants’ group allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition at post‐treatment; reasons given for those dropping out; data sought for all participants irrespective of compliance |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias ‐ training and supervision | Low risk | One‐day training for at least one facilitator of each group, plus experience of dementia care and group facilitation skills |
Other bias ‐ treatment manual | Low risk | Italian version of 'Making a difference' manual used (Spector 2006) |