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

McCurry 2012.

Study characteristics
Methods Study design: RCT
Follow‐up: 1 month
Participants Country: USA
Setting: 37 long‐term care facilities
Inclusion criteria:
  • probable or possible Alzheimer's disease diagnosis

  • ≥ 2 sleep problems on the Sleep Disorders Inventory

  • sleep problems occurring ≥ 3 times per week

  • living in an adult family home with owner/operator and staff willing to participate


Exclusion criteria:
  • pre‐existing diagnosis of a primary sleep disorder (sleep apnoea, restless legs syndrome, REM behaviour disorder)

  • major medical illness that awakens residents at night (severe pain, emphysema, uncontrolled incontinence)

  • dementia caused by alcohol abuse or Parkinson's disease

  • history of severe psychiatric disease (schizophrenia, bipolar disease)

  • medical status considered fragile by staff


Number of participants completing the study: 47 (IG 31, CG 16)
Baseline characteristics:
Residents:
  • age (years, mean): 86.6 (SD 7.2)

  • gender (female): 60%

  • MMSE (mean): 8.1 (SD 7.6)


Carers:
  • age (years, mean): 48.2 (SD 9.7)

  • gender (female): 90%


Group differences: not reported
Interventions Intervention: 4 sessions of sleep education programme for carer‐staff (in 1 month). Consisted of 1. 30‐minute in‐service education on general sleep issues and the intervention; 2. verbal and visual feedback (noise levels recorded in nursing home were presented and verbal feedback about noise levels and sources of noise given); 3. noise abatement: implementation of procedures to reduce noise (e.g. turn off unwatched televisions); 4. individualised incontinence care: research staff provided incontinence care during hourly rounds when residents were awake. Otherwise, frequency of waking residents up for incontinence care was based on residents' risk for skin problems. During incontinence care, staff attempted to reduce noise and light exposure.
Control: usual care
Outcomes
  • Night‐time total sleep, hour/minutes (actigraphy)

  • Night‐time total wake, hour/minutes (actigraphy)

  • Sleep efficiency (actigraphy)

  • Daytime sleep, hours/minutes (actigraphy)

Funding Sponsorship source:
  • Alzheimer's Association

  • National Institute of Mental Health

  • University of Washington

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Sequence generation Unclear risk Quote: "Residents were randomly assigned after the baseline assessment […] according to a 2:1 simple allocation ratio …"
Allocation concealment Unclear risk Not reported.
Blinding of participants and personnel
All outcomes Unclear risk Unknown.
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 Low risk Assessors blinded to treatment assignment.
Blinding of outcome assessors
Subjective sleep quality (carer ratings) Unclear risk No information available.
Incomplete outcome data
All outcomes Low risk 3 (6%) residents lost to follow‐up after 1 month.
Selective outcome reporting Low risk Analysis followed published study protocol.
Other sources of bias Low risk No adjustment for cluster effects as none were detected.
Quote: "Twenty‐seven AFHs [adult family homes] (73%) had only one resident study participant, and 10 AFHs had two resident participants. Analysis of variance components indicated that including site effects did not enhance the explanatory power of models."