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. 2018 Feb 13;2018(2):CD009812. doi: 10.1002/14651858.CD009812.pub2

Richards 2005.

Methods Randomised controlled trial
Duration of follow‐up: 21 consecutive days
Participants Country: USA
Participants were recruited from 1 Department of Veterans Affairs nursing home and 6 for‐profit community nursing homes in the central southeastern United States.
Inclusion criteria: age ≥ 55, baseline 85% sleep efficiency and at least 30 minutes of daytime sleep (Actigraph), living at the facility for at least 1 month, MMSE score ≤ 24
Number of participants completing the study: n = 139 (intervention group n = 71, control group n = 68)
Age (mean ± SD) years: 79 ± 8.4
Gender, female: 48.2%
Cognitive status, MMSE (mean ± SD): 8.7 ± 7.1
Care dependency: not reported
Interventions Intervention: individualised activity‐programme
Control: usual care (including any scheduled activities that the nursing home provided).
Outcomes 24‐hour sleep/wake patterns (Actigraph), costs (training, activities, administration)
Funding Veterans Health Administration, National Institute of Nursing Research, National Institutes of Health/National Center for Research Resources to the General Clinical Research Center of the University of Arkansas for Medical Sciences; USA
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Then participants were randomly assigned to one of two groups: ISAI or usual‐care control". No further information reported.
Allocation concealment (selection bias) Unclear risk No information reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No blinded to group allocation.
"The project nursing assistants implemented the ISAI and recorded the type, time, and duration of the activities. (...) As part of the ISAI, the project nursing assistants checked on the participants every hour, observed them for napping, wakened them if they were asleep, and provided ISAI. (...) Participants in this [control] group received usual care".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "The Actigraph (Ambulatory Monitoring, Ardsley, NY), a motion‐sensing device that uses an algorithm to differentiate sleep from wake based on motor activity, measured sleep/wake pattern variables."
Comment: no information about blinding reported, but the risk of bias was judged as low since only objective outcome were assessed via Actigraph.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk "Of the 147 remaining participants, seven were hospitalized, and one returned home."
Comment: no information about the allocated groups of the participants lost to follow‐up.
Selective reporting (reporting bias) Unclear risk No trial registration and no study protocol is available.
Other bias Unclear risk No primary outcome defined (multiple testing).