Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia
Conditions
Interventions
Participants are randomised to one of two groups with an allocation ratio of 2:1 (intervention:TAU) using an electronic randomisation list which has been computer generated by a statistician independe
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults with dementia (any type, any severity) 2. Sleep Disorders Inventory item score =4 (a reliable and valid measure of sleep in dementia) 3. Sleep that patient and their family judge is a problem 4. Person with dementia gives consent if has capacity OR consultee provides declaration if the person with dementia is not able to give informed consent (but is not unwilling) 5. Family carer able and willing to give informed consent 6. Family carer gives emotional or practical support at least weekly to the person with dementia
Exclusion criteria
Exclusion criteria: 1. Person with dementia living in a care home 2. Person with dementia has other primary sleep disorder diagnosis (e.g. sleep apnoea) 3. Family carer not willing or able to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of the intervention is assessed by recording the proportion of participants adhering to intervention (attending predetermined session numbers) and by the proportion of appropriate referrals consenting to the trial at baseline 2. Acceptability of the intervention is assessed through qualitative interviews after follow-up, post-unblinding | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Referral rates from the recruitment period are measured from records about eligible referrals at the end of the recruitment period 2. Follow-up rates are measured after the last follow-up, from records indicating which participants completed assessments at three months 3. All psychotropic medication prescribed is assessed by completing the Client Service Receipt Inventory (incorporating a list of medications in the last 3 months) at baseline and three months 4. Reported side effects are recorded using a study-specific questionnaire at baseline and three months 5. Acceptability of outcome measures for a future trial of clinical and cost-effectiveness is assessed through recording the completion rates of instruments (see below) at baseline and three months, the acceptability of tools from the qualitative interviews post-unblinding, and estimating the statistical power and sample requirements based on detecting significant differences in outcomes in statistical analysis Patient measures (data collected by interviewing the carer): 1. Socio-demographic details (sex, age, age when left education, last occupation, current marital status, ethnicity) are collected at baseline 2. Medication use is measured by completing a list at baseline and three months 3. Type of dementia is recorded from the referral information at baseline 4. Severity of dementia is measured using Clinical Dementia Rating at baseline 5. Sleep disorder is measured using the Sleep Disorders Inventory at baseline and three months 6. Actigraphy variables (sleep efficiency, sleep time, wake time, relative amplitude, interdaily stability, light) are obtained from acti-watches worn at baseline and three months 7. Neuropsychiatric symptoms are measured using the Neuropsychiatric Inventory at baseline and three months | — |
Countries
England, United Kingdom
Outcome results
None listed