University College London
DREAMS (Dementia Related Manual for Sleep) START (Strategies for Relatives)
Alzheimer's disease & other dementias
DREAMS START Development and Feasibility 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 trials 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 medications role), co-morbid physical illnesses and patient falls. Measures (Baseline & three months) We expect the main studys 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.