Orgeta 2015.
Study characteristics | ||
Methods | RCT | |
Participants | N = 356 (165 F/191 M) Mild‐to‐moderate dementia according to DSM‐IV criteria 76% receiving AChEI medication Mean MMSE 21.2 (SD 4.3) Age 78.2 (SD 7.5) Community |
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Interventions | Individual cognitive stimulation (delivered by informal caregivers) (N = 180) Treatment‐as‐usual controls (N = 176) |
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Outcomes | Cognition: ADAS‐Cog; MMSE Quality of Life: QoL‐AD (self‐report and proxy); DEMQOL (self‐report and proxy) Quality of relationship: Quality of the Carer‐Patient Relationship Scale (QCPR) ADL: Bristol ADL Scale Mood: GDS‐15 Behaviour problems: NPI Caregiver outcomes: Short Form‐12 Health Survey (physical (PCS) and mental (MCS) components); Hospital Anxiety & Depression Scale (HADS); EQ‐5D‐3L; Resilience Scale‐14; NPI carer distress; QCPR |
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Notes | 30 minutes, 3 times a week, for 25 weeks Imputed adjusted means used in meta‐analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was completed using a dynamic adapative allocation method, with an overall allocation ratio of 1: 1. Random allocation was stratified by site and receipt of acetylcholinesterase inhibitors (AChEIs)." |
Allocation concealment (selection bias) | Low risk | Randomisation database held at trials unit; only unblinded researchers informed of allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Full details given on attrition. ITT analyses used |
Selective reporting (reporting bias) | Low risk | Results given for all planned outcomes |
Other bias ‐ training and supervision | Low risk | Carers all received training in delivering iCST and support throughout study. |
Other bias ‐ treatment manual | Low risk | Carers all received standardised training package and manual (Yates 2014). |