Middelstädt 2016.
Study characteristics | ||
Methods | RCT | |
Participants | N = 71 (60F/11M) Mild‐to‐moderate dementia according to ICD‐10 criteria Mean MMSE 16.9 (SD 4.5; range 10‐24) Age 86.4 (SD 4.5; range 74‐102) Nursing homes |
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Interventions | Cognitive stimulation groups 'NEUROvitalis senseful' (N = 36) Treatment‐as‐usual control group (N = 35) |
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Outcomes | Cognition: ADAS‐Cog Quality of Life: QoL‐AD (self‐report and proxy) ADL: ADCS‐ADL Behaviour problems: NPI‐NH Six‐week follow‐up data provided |
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Notes | 60 minutes, twice a week for 8 weeks | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used computer generated random numbers |
Allocation concealment (selection bias) | Unclear risk | "The randomization process was then realized by a member of the research group who was blinded to the participants". Not clear how independent this process was? |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors for ADAS‐Cog and QoL‐AD blind to group assignment and not involved in any other part of the study. Group secrecy emphasised |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Details of attrition provided and followed ITT principle (also per protocol analysis) |
Selective reporting (reporting bias) | Low risk | All outcome measures mentioned in methods were reported. |
Other bias ‐ training and supervision | Unclear risk | Facilitator was researcher experienced in conducting non‐pharmacological interventions, but no details of training or supervision |
Other bias ‐ treatment manual | Low risk | "Every session was described in detail in a manual, including advice for instructions." |