Dementias and neurodegeneration Mental and Behavioural Disorders
Conditions
Interventions
Trial design:
- Feasibility study: to see if the intervention is acceptable to participants and GPs, sufficient numbers of participants can be recruited and engaged with the intervention, and sufficie
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patient participants (PLWD/MCI): 1. Aged >18 years old 2. Clinical diagnosis of dementia/MCI of any subtype and stage 3. In primary care and registered with a participating general practice 4. Residing at home or in a community care home in England 5. Has sleep problems of any type that are considered problematic by the PLWD/MCI, their family or carer 6. Have a family or professional carer who provides support at least one hour per week and is willing to solely assist with completion of outcomes (see section 6.2 carer definition) 7. Able to communicate in English sufficiently well to complete the outcome measures and questionnaires 8. Has the capacity to provide informed consent OR has a personal or professional consultee who is able to provide favourable opinion on behalf of the PLWD/MCI Carer participants: 1. Aged >18 years old 2. Resides in England 3. Able to communicate in English sufficiently well to complete the outcome measures and questionnaires 4. Has the capacity to provide informed consent 5. Has lived- or professional-experience of sleep disturbance of the PLWD/MCI who they provide care for 6. Has completed a Sleep Disorders Inventory proxy assessment of the PLWD/MCI they provide care for, resulting in a score (frequency x severity) >4 on at least one item (symptoms 1-7), as indicative of a clinically significant sleep disorder (see Appendix for questionnaire) 7. Is not already enrolled in the study with another patient participant (each carer participant can only take part once)
Exclusion criteria
Exclusion criteria: Patient participants (PLWD/MCI): 1. Deemed overburdened or has severe unstable (mental or physical) health problems 2. Unable to communicate even with augmentative and alternative communication support 3. Does not have a family or professional carer 4. Undergoing end-of-life care 5. Planned unavailability for >3 weeks during intervention and follow-up (i.e approximately the next 4 months) Carer participants: 1. Deemed overburdened or has severe unstable (mental or physical) health problems 2. Diagnosis or health condition that may impair their ability to complete outcome assessments, as determined by the carer 3. Planned unavailability for >3 weeks during intervention and follow-up (i.e approximately the next 4 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a Feasibility study that is aimed at determining whether a subsequent full-scale definitive trial should proceed. Feasibility trial outcome measures are measured using data collected in study records: 1. The proportion of people in a primary care setting who meet the following criteria (per 1000 registered patients): 1.1. PLWD/MCI with problematic sleep disturbance 1.2. PLWD/MCI with problematic sleep disturbance who also have a professional or family carer 1.3. PLWD/MCI with problematic sleep disturbance who also have a professional or family carer and meet other trial eligibility criteria 2. The proportion of eligible people who consent to participate in the study 3. The proportion of consented participants in the intervention arm who start the intervention 4. The proportion of consented participants in the intervention arm, who start the intervention and complete all three stages of the intervention: Assessment in Context (SADL); Co-created Tailored Plan consultation; and Review and Revise consultation 5. The proportion of consented participants who remain in the study until final follow-up at 15 weeks 6. The proportion of consented participants who remain in the study and provide valid outcome data for clinical and health-economic measures, including the putative primary outcome for a definitive trial (see below) at 9- and 15-week follow-ups 7. The acceptability of the intervention as assessed through the process evaluation using an online or in-person interview and an online survey at the end of the study 8. Mean and standard deviation, plus between-group mean difference with 95% confidence interval and Intraclass Correlation Coefficient (ICC) for the proposed primary outcome of the definitive trial (and any proposed outcomes that may be key secondary outcomes for which a power calculation is performed), used to verify or revise the proposed primary outcome and sample size calculation for the definitive RCT Proposed Clinical Outcome Measures for a De | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline, and the 9- and 15-week follow-ups: 1. Day-time sleeping/dozing behaviour measured using the Epworth sleepiness scale (ESS) 2. Daily living measured using the Activities of Daily Living (ADL): Assessed with the Disability Assessment for Dementia (DAD) 3. Quality of life measured using the Dementia Quality of Life Measure (DEMQOL) 4. Wellbeing measured using the EQ-5D 5 level 5. Wellbeing and quality of life measured using the ICEpop Capability measure (ICECAP-O) 6. Neuropsychiatric symptoms measured using the Neuropsychiatric Inventory Questionnaire (NPI-Q) 7. Health and social care service use measured using the Client Service Receipt Inventory (CSRI) 8. Non-visual cognitive assessment completed over the phone using the Telephone Montreal Cognitive Assessment (T-MoCA) | — |
Countries
England, United Kingdom
Contacts
Public ContactJayden van Horik
Outcome results
None listed