ISRCTN13072268
Active, not recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Camden and Islington NHS Foundation Trust
- Enrollment
- 740
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38307536/ (added 09/02/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. People with dementia (any type/ severity/ on any or no medication)
- •2\. Sleep Disorders Inventory (SDI) score \>\=4\. The SDI is a valid and reliable standalone tool for sleep disorder in people with dementia. Those who score \>\=4 have clinically significant sleep disorder
- •3\. Sleep that patient or their family judge as problematic
- •4\. Patient with capacity gives consent, or if not capacitous, consultee gives consent and patient not unwilling
- •5\. Family carer gives informed consent
- •6\. Family carer supports the person with dementia emotionally or practically at least weekly
- •7\. Person with dementia lives in their own home with someone present at night
Exclusion Criteria
- •Current exclusion criteria as of 18/12/2023:
- •1\. Known primary sleep breathing disorder diagnosis preceding dementia (e.g. sleep apnoea) from self or proxy report
- •2\. Current known heavy alcohol use from self or proxy report (AUDIT C Score \>\=8\)
- •3\. People unavailable for \>3 weeks of intervention and follow\-up (e.g. planned holiday or hospital admission
- •4\. Currently enrolled in another non pharmacological dementia RCT
- •Previous exclusion criteria:
- •1\. Known primary sleep breathing disorder diagnosis preceding dementia (e.g. sleep apnoea) from self or proxy report
- •2\. Current known heavy alcohol use from self or proxy report (AUDIT C Score \>\=5\)
- •3\. People unavailable for \>3 weeks of intervention and follow\-up (e.g. planned holiday or hospital admission
- •4\. Currently enrolled in another non pharmacological dementia RCT
Outcomes
Primary Outcomes
Not specified
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