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. 2023 Jan 3;2023(1):CD011881. doi: 10.1002/14651858.CD011881.pub2

Gattinger 2017.

Study characteristics
Methods Study design: cluster‐RCT
Follow‐up: 10 weeks
Participants Country: Switzerland
Setting: 3 long‐term care facilities
Inclusion criteria:
  • cognitive impairment

  • sleeping problem assessed by the nurse in charge and night shift nurse

  • written informed consent of the person her‐ or himself or in case of cognitive incapacity a written informed consent of an authorised person


Exclusion criteria: not reported
Number of participants completing the study: 44 (IG 22, CG 22)
Baseline characteristics:
  • age (years, mean): IG 86.36 (SD 8.6), CG 8.68 (SD 5.2)

  • gender (female): IG 16 (72.7%), CG 16 (72.7%)

  • care level 1–4: IG 3 (13.6%), CG 6 (27.3%)

  • care level 5–8: IG 14 (63.6%), CG 12 (54.5%)

  • care level 9–12: IG 5 (22.7%), CG 4 (18.2%)


Group differences:
  • no differences between IG and CG in age, sex, length of stay, and care level.

  • no differences reported in the residents' diseases and described medication, except for antipsychotics, which was significantly more often described in the IG.

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
Outcomes
  • Sleepiness during daytime (EFAS)

  • Sleep quality (PSQI)

  • Mobility data during the night‐time through mobility monitoring system

Funding Sponsorship source:
  • Swiss Federal Commission for Technology and Innovation

  • Company compliant concept

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.