Graessel 2011.
| Study characteristics | ||
| Methods | RCT | |
| Participants | N = 96 (80F/16M) (For 6‐month evaluation, N = 139 (115F/24M)) ICD‐10 criteria for primary degenerative dementia (vascular and secondary dementia excluded) 13.5% receiving anti‐dementia medication Mean MMSE 14.6 (SD 5.4) Age 85.1 (SD 5.1) Nursing homes |
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| Interventions | MAKS groups (motor stimulation, practice in activities of daily living, and cognitive stimulation) (N = 50; 6 months N = 71) Treatment‐as‐usual (N = 46; 6 months N = 68) |
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| Outcomes | Cognition: ADAS‐Cog* ADL: Erlangen Test of Activities of Daily Living (E‐ADL)*; Barthel Index**; NOSGER ADL** and IADL subscales** Behaviour: Nurses’ Observation Scale for Geriatric Patients (NOSGER)** Mood: NOSGER Mood subscale** Problem Behaviour: NOSGER Challenging behaviour subscale** Social Interaction: NOSGER Social Behaviour subscale** Care requirements: Resource Utilization in Dementia—Formal Care (RUD‐FOCA)** (*10‐month follow‐up data provided; **Data after 6 months of intervention only) |
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| Notes | 2 hours, 6 times a week for 12 months | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation used |
| Allocation concealment (selection bias) | Unclear risk | Not clear who carried out the randomisation, or how independent they were. The randomisation appears to be carried out before baseline assessment, but evaluators were blinded, so this should not introduce bias. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Evaluators were independent and blinded to treatment allocation. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Per protocol analysis only has extractable data (although ITT analysis was also done). 38% lost for per protocol analysis |
| Selective reporting (reporting bias) | Low risk | All outcomes reported (time points varied) |
| Other bias ‐ training and supervision | Low risk | Three days of training provided and compliance checked three times at each nursing home throughout study. |
| Other bias ‐ treatment manual | Low risk | "Therapists and aides received a standardized handbook from the central study site describing in detail the steps to be taken on each day of therapy." Handbook developed specifically for the study |