DREAMS (Dementia Related Manual for Sleep) START (Strategies for Relatives)
Study Code / Acronym
DREAMS STARTAward Number
14/220/06Programme
Health Technology AssessmentStatus / Stage
CompletedDates
1 February 2016 -31 October 2017
Duration (calculated)
01 years 08 monthsFunder(s)
NIHRFunding Amount
£404,291.16Funder/Grant study page
NIHRContracted Centre
University College LondonContracted Centre Webpage
Principal Investigator
Professor Gillian LivingstonPI Contact
g.livingston@ucl.ac.ukWHO Catergories
Development of novel therapiesRisk reduction intervention
Disease Type
Dementia (Unspecified)CPEC Review Info
| Reference ID | 77 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Study Code / Acronym | DREAMS START |
|---|---|
| Award Number | 14/220/06 |
| Status / Stage | Completed |
| Start Date | 20160201 |
| End Date | 20171031 |
| Duration (calculated) | 01 years 08 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | University College London |
| Contracted Centre Webpage | |
| Funding Amount | £404,291.16 |
Abstract
We will develop a manualised intervention for sleep disorder in dementia and examine feasibility of a full scale trial. Sample size. 40 intervention (larger to allow precise estimate of proportion adhering to intervention): 20 control will allow calculation of acceptable 95% Confidence Intervals (CI) for continuation to the main trial; namely: 1 Adherence to intervention-expected value 75% (95% CI=59-87) 2 Appropriate referrals consenting to study-expected value 50% (95% CI=41-59). We expect that our stop-go measures will be related to the proportion adhering- >=70% – go to main trial 60-69 consider a modified trial design to increase adherence <60 do not progress to main trial using this model. It will also provide data for the main trial's sample size calculation:- measures' standard deviations; correlations between baseline and followup measurements and drop out rate. Inclusion criteria (all) Adults with dementia (all types/severities) Sleep Disorders Inventory score>3 Sleep they or their family judge is a problem Consent from both of dyad: Patient (informed/consultee); family carer (informed). Exclusion criteria Patient living in a care home or has other sleep disorder diagnosis. Outcomes Intervention group Treatment Adherence (attending predetermined session numbers) Both arms Feasibility of recruitment-agreement to study/randomisation and referral rates. Carer involvement in the intervention quantitatively (and qualitatively from follow-up interviews), all psychotropic medication prescription (rescue medication’s role), co-morbid physical illnesses and patient falls. Measures (Baseline & three months) We expect the main study’s primary outcome will be actigraphy (sleep efficiency) but will be informed by our pilot. We will inform feasibility and test procedures by collecting validated clinical and cost effectiveness measures planned for a full trial. We will collect from the carer to ensure data comparability (interview time about 50 minutes). Patient: Dementia- type diagnosed and severity (Clinical Dementia Rating) challenging behaviour (Neuropsychiatric Inventory), Epworth sleepiness scale (daytime sleepiness). Carer sleep(PSQI), mood/wellbeing (HADS) and burden (Zarit). Patient services use (CSRI)will detail treatment as usual (TAU) and with patient (DEMQOL proxy) and carer (HSQ health-related quality of life scales for cost effectiveness. Workpackage 1 (WP; 6 months) Ethics /governance approvals. Co-applicants develop manual using MRC framework for complex interventions, incorporating existing evidence and qualitative interviews (family carers and people with dementia) about content, clarity, practicality and acceptability. It will comprise education session, activity, light, routine, maintenance plan for both of dyad. Recruit and train psychology graduates as researchers and therapists. It will be delivered individually by graduates to allow scaling up WP 2 (10 months) Recruit from memory clinics. Assessors will be blinded to randomisation status. We will randomise individually to intervention or TAU asking participants not to tell assessors. Post-unblinding, RAs will interview 20 carers and patients about the intervention (involvement, practicality, acceptability). WP 3 (5 months) Analysis and write up Management Management & Steering Committees – ensure adherence to protocol, legal framework and PPI involvement.
Plain English Summary
There are expected to be 850000 people in the UK in 2015 living with dementia, two-thirds live in the community, and their numbers are increasing rapidly as the population ages. UK dementia care costs £26.3 billion. Sleep disturbances in dementia are common and varied, including reduced night time sleeping, night wandering and excessive daytime sleepiness. Sleep influences all aspects of life and is important in day-to-day function and quality of life. Family carers are often woken by their relatives’ sleep difficulties and become very tired. They may feel depressed and be unable to continue caring at home. Night time care costs can be unaffordable for those who wish to continue caring at home. We propose to develop (in consultation with families and people with dementia) an intervention to help people with dementia and sleep disturbance living at home, based on the existing evidence as to what works. Families will be very involved. In practice, most people with dementia in the study, will have carers with them most nights, as they will either be referred as causing disturbance to carers sleeping in the same house, or have carers because it’s unsafe to leave them alone. While developing the intervention we will put it in a manual so it can be used by others. We will then test feasibility for a full-scale trial through a small randomised study (our power calculation suggests 40 participants in intervention and 20 in non-intervention group). We will measure whether people attend, the need for sleep medication and also use other scales we would use in a full scale study, e.g. CSRI which details services used (to consider usual practice in the group we are not intervening in and cost, carers sleep and we will ask families about their experience. The whole study will take 21 months. As the causes of sleep disturbances in dementia differ, our intervention will be tailored to the person with dementia’s individual problems. It will be delivered individually, through a partnership of health workers and family carers. The health worker will be a supervised psychology graduate, so that it can be rolled out nationally if successful. We have done this with other similar projects and our intervention has continued to work over at least two years. Our team includes a family carer and experts in sleep; dementia; behaviour interventions and statistics. We will work collaboratively encouraging family carers to try techniques, and write in their own manual what works for them. We will begin with an educational session for all family carers and patients if able covering sleep and circadian processes and how sleep and brain function change with ageing and dementia. We will find out about the timing of the person’s sleep-wake schedule using one week of actigraphy (a re-usable wristwatch which monitors movement and sleep rhythms). To improve night-time sleep we will work with the dyad to use cues that influence the person’s biological rhythms e.g. exposure to daylight, outdoor/physical activities, regular meal timing and indoor routines, regular timing of bed and rising, morning wake-up light, standardised meal times and establish a pre-bed settling routine and management of wakeful episode and daytime naps. In the last session, family carers will agree a future maintenance plan using techniques that were acceptable and successful for them and keep their personalised manual.