McCurry 2011.
Study characteristics | ||
Methods |
Study design: RCT Follow‐up: 2 months |
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Participants |
Country: USA Setting: independent living (with informal carers) Inclusion criteria:
Exclusion criteria:
Baseline characteristics: Patients:
Carer:
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. |
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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. |
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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 | 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. |