| Study name |
A parallel multi‐centre randomised controlled trial to determine the clinical and cost‐effectiveness of DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people living with dementia and their carers |
| Methods |
Randomised controlled trial |
| Participants |
Study population: 370 people living with dementia at home and experiencing sleep difficulties and their family carers
Inclusion criteria:
people with dementia (any type/severity/on any or no medication) Sleep Disorders Inventory score ≥ 4, a valid and reliable standalone tool for sleep disorder in people with dementia. Score of ≥ 4 have clinically significant sleep disorder sleep that patient or their family judge as problematic patient with capacity gives consent, or if not capacitous, consultee gives consent and patient not unwilling family carer gives informed consent family carer supports the person with dementia emotionally or practically at least weekly person with dementia lives in their own home with someone present at night
Exclusion criteria:
known primary sleep breathing disorder diagnosis preceding dementia (e.g. sleep apnoea) from self‐ or proxy report. current known heavy alcohol use from self‐ or proxy report (AUDIT C Score ≥ 5) people unavailable for > 3 weeks of intervention and follow‐up (e.g. planned holiday or hospital admission currently enrolled in another non‐pharmacological dementia randomised controlled trial
|
| Interventions |
Intervention: multimodal intervention. 6 sessions over approximately 3 months (with sessions offered flexibly weekly to fortnightly) for intervention group. Sessions will be delivered to family carers alone or where appropriate to the family carer and the person living with dementia together.
Control: usual care |
| Outcomes |
Resident sleep at 8 months measured using Sleep Disorders Inventory |
| Starting date |
1 February 2021 |
| Contact information |
p.rapaport@ucl.ac.uk |
| Notes |
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