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)
Study Code / Acronym
DREAMS STARTAward Number
NIHR128761Award Type
HTA Clinical Trials & EvaluationProgramme
Health Technology AssessmentStatus / Stage
ActiveDates
1 September 2020 -1 May 2024
Duration (calculated)
03 years 08 monthsFunder(s)
NIHRFunding Amount
£1,810,001.82Funder/Grant study page
NIHRContracted Centre
Camden and Islington NHS Foundation TrustContracted Centre Webpage
Principal Investigator
Dr Penny RapaportPI Contact
p.rapaport@ucl.ac.ukPI ORCID
0000-0003-0479-6950WHO Catergories
Economic Impact of DementiaRisk reduction intervention
Disease Type
Dementia (Unspecified)CPEC Review Info
| Reference ID | 480 |
|---|---|
| Researcher | Reside Team |
| Published | 29/06/2023 |
Data
| Study Code / Acronym | DREAMS START |
|---|---|
| Award Number | NIHR128761 |
| Status / Stage | Active |
| Start Date | 20200901 |
| End Date | 20240501 |
| Duration (calculated) | 03 years 08 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | Camden and Islington NHS Foundation Trust |
| Contracted Centre Webpage | |
| Funding Amount | £1,810,001.82 |
Abstract
Does DREAMS START improve sleep disturbance for people living with dementia in their own homes and their family carers compared to treatment as usual (TAU). Background About 40% of people living with dementia have sleep disturbances and there are no known effective treatments. Family carers find this may lead to interruption of their own sleep, low mood, and breakdown of care at home. Our DREAMS-START feasibility study found the intervention delivered individually to family carers by supervised graduate facilitators, and study design, were acceptable and feasible. It is an evidence based, manualised treatment, with information about sleep and dementia. It supports carers to use cues to influence circadian rhythms, including light and activity, to establish pre-bed settling routine and night de-arousal. Objectives Primary: To determine if DREAMS START improves sleep disturbances in people living with dementia at home at 8 months(m) compared to TAU, measured on Sleep Disorder Inventory (SDI) a valid proxy measure. Secondary – to determine if it: 1. Is cost-effective. 2. Is effective at 4m. 3. Improves people with dementia and family carers’ quality of life. 4. Improves family carers’ sleep, affective symptoms and burden. We will also investigate whether mechanisms of any changes are increases in patient’s daytime movement and light exposure; and if effective, how we can optimise the intervention for NHS implementation at scale. Methods Design: Multi-centre parallel group superiority randomised controlled trial (RCT) with masked outcome assessment. Participants (power calculation n=370) randomised 1:1 to intervention or TAU. We will conduct an internal pilot and process evaluation. Settings: Memory clinics and primary care through five mental health trusts. Participants: People with a clinical diagnosis of dementia with sleep disturbances (scoring 4 on any SDI item and judged by them or family as a problem) living in their own homes and their primary family carer. Primary outcome (8m): SDI Secondary outcomes (4m and 8m): Person with dementia – Cost-effectiveness: Client Service Receipt Inventory (CSRI) and EQ5D 5L proxy; SDI (8m), quality of life (DEMQOL-Proxy), neuropsychiatric symptoms (NPI), daytime somnolence (ESS), medication use, side effects. Family carer – burden (ZBI), sleep disturbance (SCI), mood (HADS) and quality of life (HSQ) and EQ5D 5L. Process evaluation: We will record intervention attendance and rate therapist fidelity. After 8m outcomes, we will conduct qualitative interviews with 15-20 participants and 5 staff delivering the intervention. We will collect person with dementia’s one-week actigraphy (Axivity AX3) baseline and pre-8m assessment to explore potential change mechanisms. Timelines for delivery WP1 Set up (1-5m): Site initiation, staff recruitment and training, intervention adaptation. WP2 RCT (6-37m) with internal pilot (6-15m)reporting in month 15. WP3 Mixed methods process evaluation (15-42m). WP4 Analysis, write up and dissemination (37-44m). Anticipated impact and dissemination Impact and benefit for: 1. People living with dementia and their families. 2. Academia: building academic capacity and scientific knowledge even if ineffective. 3. Those implementing and commissioning health and social care. We will achieve this through implementation toolkits, peer-reviewed publications, dissemination events and targeted engagement.
Plain English Summary
Why is this important? Many people living with dementia have disturbed sleep, including reduced night-time sleep, night-time wandering and daytime sleepiness. They often wake family members, who may become exhausted, stressed and unhappy. Night-time paid care may be unaffordable and care at home may break down. What do we already know? There are currently no known effective, safe treatments for sleep problems in people with dementia, possibly because there may be many causes even in the same person. These include brain changes from dementia, worry and physical pain. Therefore, we would not expect any single treatment, except possibly sleeping tablets, to work. Sleeping tablets, however, have not been found to work for people with dementia, but do increase falls and hospital admissions. Our team of experts – in sleep, dementia interventions, and people whose lives have been affected by dementia – developed DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) using the best evidence and what people felt was important to them. It has six-sessions, working with family members, to improve sleep for people living with dementia. It uses several approaches; such as increasing light, activity, comfort, routine and relaxation. We use it flexibly, based on what someone needs and what works for them. We train and supervise health workers with a psychology degree to deliver DREAMS START. They deliver it to family carers individually at home (people with dementia can also join sessions) and together they work out and try ideas to improve their relative’s sleep. We completed a small study to see if DREAMS START was feasible (if people agreed to take part) and acceptable (if people completed and liked it); comparing people with dementia who received it with those who had usual treatment without DREAMS START. It was feasible and effective, as about two-thirds of people approached agreed to participate (62), and about 90% finished the six-sessions; nearly all liked it. Most people taking part were from memory services. It appeared promising in improving sleep. Participants made suggestions for future improvements. What do we want to find out? Our first question is does DREAMS START work: Do people with dementia living at home sleep better 8 months after receiving DREAMS START compared to people who do not receive it? We also want to know if it works at 4 months (just after the intervention), if it improves quality of life, is good value, helps families and, if it works, how it works. We have worked out we need 370 people to answer our first question. We will recruit from five varied NHS sites for a randomised trial. Randomised means a computer decides who has DREAMS START and who only has the treatment they would get anyway. We will make small changes to DREAMS START (e.g. offering it either weekly or two weekly, rather than only weekly; and using a text reminder service) based on advice from our earlier study. We will ask family carers to rate their relatives’ sleep on a widely used well-tested questionnaire (Sleep Disorders Inventory) which family carers found clear and relevant in our earlier study. If DREAMS START works, it will mean services can offer an effective treatment to improve the lives of people with dementia and their families. We will work with people affected by dementia and sleep disturbances, and service providers, throughout the project to ensure potential benefits can be widely rolled out.
Aims
To determine if DREAMS START improves sleep disturbances in people living with dementia at home at 8 months(m) compared to TAU, measured on Sleep Disorder Inventory (SDI) a valid proxy measure. Secondary – to determine if it: 1. Is cost-effective. 2. Is effective at 4m. 3. Improves people with dementia and family carers’ quality of life. 4. Improves family carers’ sleep, affective symptoms and burden. We will also investigate whether mechanisms of any changes are increases in patient’s daytime movement and light exposure; and if effective, how we can optimise the intervention for NHS implementation at scale.