Dementia or mild cognitive impairment Mental and Behavioural Disorders
Conditions
Interventions
- Feasibility study: To see if the use of a contactless sleep tracker is feasible and acceptable to patient participants, carer participants, and GPs
if sufficient numbers of participants can be recruited and will engage with the objective sleep measurements (alongside the other outcome assessments and the tailored intervention)
if sufficient data can be collected to objectively assess sleep (and general health and wellbeing) across the 15-week study period.
- Single-Arm: All participants will complete all outcome assessments
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 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 poor sleep of any type or has expressed an interest in improving their sleep,as indicated 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 7. Able to understand and communicate in spoken and written English well enough to complete the outcome measures and questionnaires 8. Has capacity to provide informed consent OR has a personal or nominated consultee who is able to provide the opinion that the PLWD/MCI would have no objection to taking part in the study CARER PARTICIPANTS 1. Aged >18 years 2. Resides in England 3. Able to understand and communicate in spoken and written English well enough to complete the outcome measures and questionnaires 4. Has capacity to provide informed consent 5. Has lived- or professional-experience of poor sleep in the PLWD/MCI who they provide care for,or has noted an interest from the PLWD/MCI in improving their sleep 6. Is not already enrolled in the study with another patient participant (each carer participant can only take part once) 7. Patient participant residence (at home or in a community care home) offers physical space at the bedside for the positioning of the contactless sleep tracker
Exclusion criteria
Exclusion criteria: PATIENT PARTICIPANTS (PLWD/MCI) 1. Deemed overburdened or has severe unstable (mental or physical) health problems 2. Unable to communicate (in English) 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 next 4 months) 6. Carer is unable and/or unwilling to handle (e.g.,switch on and off) the contactless sleep tracker 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 next 4 months) 4. Unavailability or unwillingness to participate in a semi-structured interview relating to the lived experience of using the contactless sleep tracker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. The proportion of people in a primary care setting who meet the following criteria (per 1000 registered patients): 1.1. PLWD/MCI with poor sleep or wish to improve their sleep, and who also have a professional or family carer measured using screening logs at screening. 1.2. PLWD/MCI with poor sleep or wish to improve their sleep, who also have a professional or family carer, and meet the other eligibility criteria measured using eligibility assessment records at recruitment. 2. The proportion of eligible people who consent to participate in SleepXact measured using screening logs, eligibility assessment records, and consent forms at recruitment. 3. The proportion of consented participants who complete at least one objective sleep monitoring session measured using the contactless sleep tracker at the baseline, 9-week, and 15-week follow-up assessments. 4. Total number of nights with use of the contactless sleep tracker measured using the contactless sleep tracker at the baseline, 9-week, and 15-week follow-up assessments. 5. Number of nights with available recorded data (i.e., no significant data loss) from the contactless sleep tracker measured using the contactless sleep tracker at the baseline, 9-week, and 15-week follow-up assessments. 6. Median hours of device recording per night measured using the contactless sleep tracker at the baseline, 9-week, and 15-week follow-up assessments. 7. Median sleep recording quality with the contactless sleep tracker, measured using the contactless sleep tracker at the baseline, 9-week, and 15-week follow-up assessments. 8. Objective sleep and wake summary measures, assessed using the contactless sleep tracker at baseline, 9-week, and 15-week follow-up, including (but not limited to): 8.1. Total time spent in bed 8.2. Sleep onset latency (i.e., the time taken to fall asleep) 8.3. Total sleep time 8.4. Wake after sleep onset (i.e., time spent awake after sleep onset) 8.5. Sleep efficiency (total sleep t | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of consented participants who remain in the study until final follow-up at 15 weeks measured using study records at the end of the study. 2. The proportion of consented participants who remain in the study until final follow-up and provide valid outcome data, including the objective sleep measure, at baseline and both follow-up assessments measured using contactless sleep tracker data and study records at baseline, 9 weeks, and 15 weeks. 3. Acceptability and practicality of the contactless sleep tracker to the participants is measured using semi-structured interviews with the carer participant during the 15-week follow-up period. 4. Usefulness of the contactless sleep tracker for identification and management of sleep problems in PLWD/MCI is measured using an online GP survey and qualitative elicitation focus groups with GPs during the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactBindiya Shenoy
Outcome results
None listed