None listed
Conditions
Brief summary
Sleep disturbances are common among people living with dementia, with consequences far reaching for the person, their carers and care systems. Sleep disturbances result in decreased quality of life for the person with dementia and cause significant stress for caregivers. Additionally, sleep disturbances are associated with increased admissions to care settings and healthcare costs. As such, sleep disturbances for people living with dementia are recognised as a major challenge that requires addressing. Nonpharmacological interventions are prioritised for the treatment of sleep disturbances; however, medication is frequently used, with a range of risks (including increased falls and confusion). Currently there is no gold standard sleep intervention for people with dementia. Use of weighted blankets is emerging as a safe sleep intervention option, although little is known about the effectiveness of use for people with dementia. A staged investigation will be conducted to 1) examine the effectiveness of weighted blankets as a sleep intervention for people with dementia; 2) understand the barriers and facilitators to use of weighted blankets; and 3) co-design a plan for future implementation across a range of settings. This trial reports on stage 1 of the project. During this stage we will recruit 14-18 participants living in a dementia-care unit to be randomly divided into either the intervention group or usual care group. The intervention group will use the weighted blanket overnight for two weeks, then the groups swap. A range of measurements, including sleep duration and quality, and medication use, to determine the blankets’ impact. We hypothesize that participants in the intervention group will have improved sleep outcomes and reduced behavioral and psychological symptoms of dementia. Research questions: 1. Are weighted blankets an effective and feasible sleep intervention for people with behavioural and psychological symptoms of dementia? 2. What are the implementation strategies for uptake of weighted blankets for people with behavioural and psychological symptoms of dementia in an inpatient setting? 3. What are the recommended implementation strategies for uptake of weighted blankets for people living with dementia across a range of settings?
Interventions
A weighted blanket, up to 12% of the person’s body weight, for overnight use for two consecutive weeks under nursing supervision. No wash out period is required as the effects of the weighted blanket cease on removal of the the weight. The intervention will follow the service Clinical Protocol for Sensory Modulation which states the user needs to be able independently remove or free themselves from the weighted blanket. Use of weighted blankets will be recorded daily in patient records. Weighted
A weighted blanket, up to 12% of the person’s body weight, for overnight use for two consecutive weeks under nursing supervision. No wash out period is required as the effects of the weighted blanket cease on removal of the the weight. The intervention will follow the service Clinical Protocol for Sensory Modulation which states the user needs to be able independently remove or free themselves from the weighted blanket. Use of weighted blankets will be recorded daily in patient records. Weighted blankets used are commercially available and have soft glass bead fillings and a fleece cover.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults admitted to the specialised dementia care unit with severe dementia as assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and assessed as having at least one sleep problem as assessed using the Sleep Disorder Inventory (SDI). Trialling a weighted blanket as a non-pharmacological sleep intervention, will be discussed with potential participants nearest relative/guardian within their usual multi-disciplinary care and consent gained by proxy. The researchers will provide educational sessions about the trial to families and information about the project will be included in unit newsletters for families. Following consent, a weighted blanket risk assessment will be conducted by an occupational therapist to determine safety and suitability.
Exclusion criteria
People who are unable to independently remove a lesser weight blanket (3kg) or who are receiving palliative care.
Outcome results
None listed