Kao 2016.
Methods | A 2‐step cluster‐randomised trial to compare the long‐term effects of spaced retrieval (SR) training and SR training combined with Montessori activities (SR+M) and a control condition in persons with dementia suffering from hyperphagia | |
Participants | 148 participants, recruited from 8 dementia special care units in China, who had received a diagnosis of dementia and hyperphagia‐related behaviours from a physician | |
Interventions | Participants in the SR condition (n = 48) and in the SR+M condition (n = 52) participated in thirty 40‐minute sessions over 6 weeks, which were held in dementia special care units. The SR sessions involved learning and reviewing a memory message. SR+M sessions involved the same activity, as well as practice‐based structured Montessori activities Interventions were delivered by 2 memory trainers who had received training in SR and Montessori activity methods Participants in the control condition (n = 48) participated in the usual activities of the institution, which did not involve any particular memory training activities |
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Outcomes | Outcomes included hyperphagic behaviours, measured by a 19‐item scale of hyperphagia in residents with dementia, and associated caregiver distress, measured by a scale of distress of the caregiver in response to hyperphagic behaviours Participants were assessed at baseline, immediately after the training period, and at months 1, 3, and 6 after completion of the training | |
Country | China | |
Registration status | Retrospectively registered | |
Conflict of Interests | No | |
Notes | We contacted study authors to ask for relevant scores (at all assessment occasions) and to find out more details about the scales used ("scale for hyperphagia in residents with dementia", and "scale of distress of the caregiver to hyperphagic behaviour"). No response was received | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Although the study was described as a randomised controlled trial, no information on the method of randomisation was provided |
Allocation concealment (selection bias) | High risk | Study authors did not mention allocation concealment; for this reason, we assumed this was not done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study authors described the study as a single‐blind RCT; however, this refers to the outcome assessment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The research assistants were blinded to the randomisation of subjects" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No outcome data were missing. Study authors reported the results of those who completed the study and explained the reasons why some participants dropped out. They provided a flow diagram of the study that is adherent to CONSORT |
Selective reporting (reporting bias) | High risk | Study authors did not present findings for some of the outcomes mentioned in the "Methods" section |
Other bias | Low risk | Study appears to be free of other sources of bias |