Gattinger 2017.
Study characteristics | ||
Methods |
Study design: cluster‐RCT Follow‐up: 10 weeks |
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Participants |
Country: Switzerland Setting: 3 long‐term care facilities Inclusion criteria:
Exclusion criteria: not reported Number of participants completing the study: 44 (IG 22, CG 22) Baseline characteristics:
Group differences:
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Interventions | Open 2‐phase RCT: duration of first phase 10 weeks, second phase 3 months. Intervention: implementation of motion monitoring system, education (sleep and dementia, monitoring system), 3 sleep case conferences led by an advanced nurse practitioner and 2 sleep case conferences led by an internal registered nurse Control: education (sleep and dementia), 3 sleep case conferences led by an advanced nurse practitioner, 2 sleep case conferences led by an internal registered nurse |
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Outcomes |
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Funding |
Sponsorship source:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence generation | Unclear risk | Simple randomisation used to assign the wards to IG and CG. |
Allocation concealment | Unclear risk | Not reported, but seemingly recruitment of residents before randomisation. |
Blinding of participants and personnel All outcomes | Unclear risk | Obviously not blinded, but unclear relevance. |
Blinding of participants and personnel Subjective sleep quality (carer ratings) | Unclear risk | Unknown. |
Blinding of participants and personnel Objective sleep measures | Unclear risk | Unknown. |
Blinding of outcome assessors Objective outcome measures | High risk | Staff assessed primary outcome measure. |
Blinding of outcome assessors Subjective sleep quality (carer ratings) | Unclear risk | No information available. |
Incomplete outcome data All outcomes | Low risk | 2/24 participants (IG) and 5/27 participants (CG) lost to follow‐up mostly due to death which seems expectable in this population. For 'sleep quality', results were only available for only 15/22 residents in the IG (no reason given). |
Selective outcome reporting | High risk | The study registration listed the Swiss version of neuropsychiatric inventory for nursing home as primary outcome, which was not mentioned in the study. |
Other sources of bias | High risk | Contamination possible as wards in the same nursing homes belonged to both IG and CG. |