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

McCurry 2011.

Study characteristics
Methods Study design: RCT
Follow‐up: 2 months
Participants Country: USA
Setting: independent living (with informal carers)
Inclusion criteria:
  • ≥ 2 sleep problems occurring several times a week measured according to the 7‐item Sleep Disorders Inventory

  • diagnosis of probable or possible Alzheimer's disease according to Group Health Cooperative medical record or confirmed in writing by participants' primary care physicians

  • ability to walk across a room

  • living with a carer who could monitor sleep and implement treatment recommendations

  • score < 32 on the sleep apnoea subscale of the Sleep Disorders Questionnaire

  • agreement to make no changes in sedating medication use (type or dose) during the 2‐month active treatment period


Exclusion criteria:
  • previously diagnosed primary sleep disorder (sleep apnoea, restless legs, periodic leg movements syndromes, rapid eye movement sleep behaviour disorder)


Baseline characteristics:
Patients:
  • age (years, mean): IG1 82.2 (SD 8.5), IG2 80.6 (SD 7.3), IG3 80.0 (SD 8.2), CG 81.2 (SD 8.0)

  • gender (female): IG1: 53%, IG2 56%, IG3 61%, CG 51%

  • MMSE (mean): IG1 19.2 (SD 7.7), IG2 17.9 (SD 7.0), IG3 19.1 (SD 5.8), CG 18.7 (SD 6.9)


Carer:
  • age (years, mean): IG1 70.4 (SD 13.6), IG2 68.9 (SD 14.4), IG3 73.3 (SD 13.2), CG 72.6 (SD 11.5)

  • gender (female): IG1 72%, IG2 62%, IG3 61%, CG 67%


Number of participants completing the study: 132 (IG1 32, IG2 34, IG3 33, CG 33)
Group differences: no pretreatment group differences in any participant or carer demographic variables or any group differences in any baseline actigraphic or subjective measurements of participant sleep or in any other covariate measures.
Interventions Interventions duration 2 months. Participants in all groups received 3 × 1‐hour in‐home training visits and 2 brief telephone calls to reinforce caregiver use of the daily log.
Intervention 1: walking and sleep hygiene recommendations
Intervention 2: SunRay light box (equal to approximately 2500 lux) for 1 hour/day and sleep hygiene recommendations
Intervention 3: guided sleep education, walking, light box. The carer sleep education consisted of 6 training sessions. In session 1, carers learned to develop an individualised sleep plan for residents, aiming to reduce daytime napping, establish bedtime routine, and identify reasons for night‐time awakenings. In session 2, carers were trained about implementing the daily light exposure programme. Sessions 3–6 was on identifying reasons of night‐time awakenings as well as challenges in implementing the sleep, walking, and light exposure plans.
Control: non‐directive dementia care support during the 3 in‐home training visits, including non‐directive dementia care support, but provided no training about sleep‐ or dementia‐related issues.
Outcomes
  • Total wake time at night, minutes (actigraphy)

  • Number of awakenings (actigraphy)

  • Total sleep, minutes (actigraphy)

  • Sleep percentage, % (actigraphy)

  • Sleep quality (Sleep Disorders Inventory)

Funding Sponsorship source:
  • National Institute of Mental Health (Grant MH072736)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Sequence generation Low risk The random allocation sequence was obtained from a computer program that blocked in groups of 12 participants (p.1394).
Allocation concealment Low risk A research co‐ordinator assigned treatment conditions using sealed envelopes containing the random assignment (p.1394).
Blinding of participants and personnel
All outcomes Unclear risk Unknown.
Blinding of participants and personnel
Subjective sleep quality (carer ratings) High risk Carers unblinded (see below).
Blinding of participants and personnel
Objective sleep measures Low risk Not blinded, but without influence on outcomes due to method (actigraphy) (p.1395).
Blinding of outcome assessors
Objective outcome measures Low risk Interviewers blind to treatment assignment conducted assessments at baseline, 2‐month (immediately after treatment) follow‐up, and 6‐month follow‐up (p.1395).
Sleep–wake activity was measured at each assessment using a Micro‐Mini Motionlogger actigraph (p.1395).
Blinding of outcome assessors
Subjective sleep quality (carer ratings) Unclear risk Carers unblinded due to setting (independent community‐living) and type of intervention (e.g. daily walks) (both p.1393).
It remains unclear if carers knew if they were part of the IG or CG but maybe this had no effect on bias.
Incomplete outcome data
All outcomes Low risk Dropout rate reported (p.1396), ITT conducted (p.1397).
Selective outcome reporting Low risk Registered: ClinicalTrials.gov (Identifier: NCT00183378).
Missing outcomes: residential status, carer sleep (not relevant here).
Other sources of bias Low risk None.