Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000144718
Ethics application status
Approved
Date submitted
29/10/2021
Date registered
27/01/2022
Date last updated
17/03/2024
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Dementia, Sleep and Wellbeing Study: targeting sleep and mood in people living with dementia and their care partners.
Scientific title
An open pilot feasibility trial of a multimodal sleep intervention on sleep disturbance in community-dwelling people living with mild dementia and primary care partners.
Secondary ID [1] 305566 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 323979 0
Condition category
Condition code
Neurological 321480 321480 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The developed intervention is therapist-assisted and multimodal, encompassing cognitive behavioural therapy for insomnia (CBT-I), mindfulness and light therapy (seeking natural light upon awakening, avoiding light at night) components to target sleep and mood in dyads of people with dementia and their primary care partner. There will be no use of external light therapy devices (e.g., glasses or light boxes).

Components will include: sleep education, stimulus control, sleep hygiene, strategies for fatigue and self-care, seeking or avoiding exposure to bright light, mindfulness (e.g., deep breathing and present-moment focus).

The focus of the intervention is on upskilling care partners in using strategies targeting their own sleep, including supporting the sleep of the person they are caring for. For this reason, it will not be required for the person living with dementia to attend all sessions apart from personalised dyad sessions. The group sessions are focused on strategies for care partners with there being the option to attend for the participants living with dementia.

• The intervention will consist of personalised dyad-only sessions and group-based delivery.
• All sessions will go for 60-90 minutes. Week 1 and 4: personalised dyad-only session; Week 2-3 and 5-6: small group-based sessions of care partners (optional attendance for people living with dementia). Ad hoc email support will be made available.
• In the personalised, dyad-only session in Week 1, the interventionist will assess unique sleep concerns of the dyad and deliver core components in light of these circumstances. In Week 4, there will be another personalised dyad-only session to overcome barriers and encourage adherence. The aims of the personalised sessions are to deliver pertinent strategies (e.g., sleep psychoeducation, stimulus control mindfulness), encourage adherence and personalise strategies in light of unique needs.

• The intervention will be delivered via Zoom. Personalised dyad-only sessions will focus on psychoeducation about sleep and discussing key strategies. The group sessions will focus on providing a reflective space to discuss strategies and share experiences of implementing strategies with other participants.
• It is expected participants will engage in sessions at their shared home.
• Sessions will be facilitated by a registered psychologist (minimum two years’ experience delivering CBT-I) and a provisional psychologist with supervision.
• Digital handouts (overview and reminders of key strategies) will be provided at the end of each session – these are specifically designed for the study.
• Adherence to intervention will be quantitatively (Client Satisfaction Questionnaire, self-rated helpfulness and usefulness of different strategies) and qualitatively (open feedback) assessed at post-intervention and one-month follow-up questionnaires. The psychologist will also check in regarding adherence each session to motivate participants in using strategies.
Intervention code [1] 322043 0
Treatment: Other
Intervention code [2] 322338 0
Behaviour
Comparator / control treatment
NIL - this is an open pilot trial with no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330191 0
1. FEASIBILITY (Implementation) measured by:
a) % of sessions attended by carers (#/6)
b) Drop-out rate of carers

This is a composite primary outcome
Timepoint [1] 330191 0
From Week 1 of intervention (week 3 following study commencement) to post-intervention i.e., 8 weeks post-commencement of study.
Primary outcome [2] 330193 0
2. FEASIBILITY (Acceptability) measured by scores of carers (of at least 75%) on the Client Satisfaction Questionnaire (Attkisson & Zwick, 1982) in post-intervention questionnaire.
Timepoint [2] 330193 0
Post-intervention (i.e., 8 weeks following commencement of study).
Secondary outcome [1] 402303 0
PRELIMINARY EFFICACY (Sleep). This is a composite outcome measured by scores of CARERS:

1. Pittsburgh Sleep Quality Index
2. Sleep Disturbance Inventory (NOTE: this is a rating of sleep in the person with dementia)
3. Insomnia Severity Index
and
4. objectively-assessed sleep measured by actigraphy (sleep efficiency [%], sleep onset latency [mins], wake after sleep onset [mins]).
Timepoint [1] 402303 0
Changes in scores from (week 2 following study commencement) to post-intervention (week 8 following commencement) for following variables (assessed in questionnaires):
1. Pittsburgh Sleep Quality Index
2. Sleep Disturbance Inventory
3. Insomnia Severity Index

Week 1-2 post=study commencement to weeks 7-8 following study commencement for Actigraphy.
Secondary outcome [2] 405237 0
PRELIMINARY EFFICACY (Daytime impairment) measured by scores of carers on PROMIS Sleep Related Impairment
Timepoint [2] 405237 0
Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires
Secondary outcome [3] 405238 0
PRELIMINARY EFFICACY (Mood) assessed by CARER scores on
1. Depression, Anxiety and Stress Scale (DASS-21)
2. PROMIS Anxiety – SF – 8a
3. PROMIS Depression – SF – 8a

NOTE: This is a composite outcome
Timepoint [3] 405238 0
Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires
Secondary outcome [4] 405239 0
PRELIMINARY EFFICACY (CARER Quality of life) measured by carer scores on Health Questionnaire (EQ-5D-5L)a
Timepoint [4] 405239 0
Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires
Secondary outcome [5] 405240 0
PRELIMINARY EFFICACY (PERSON LIVING WITH DEMENTIA Quality of life) measured by The Alzheimer’s Disease-related Quality of Life scale (QoL-AD)*
Timepoint [5] 405240 0
Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires

Eligibility
Key inclusion criteria
PEOPLE LIVING WITH DEMENTIA:

a) Living with dementia (any form or severity);
b) Receives overnight support from care partner at least 3 times per week
c) Can provide informed consent or assent
d) Carer-reported sleep concerns (rated on a single-item statement)

CARE PARTNERS:
a) Self-report issues with their sleep (scores of 5 or more on the Pittsburgh Sleep Quality Index)
b) Living with and supporting a person with dementia at least three nights per week (responsible for providing overnight care when needed);
c) Able to communicate confidently in English;
d) Regular access to phone, email and internet;
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
PEOPLE LIVING WITH DEMENTIA:

a) Living in a residential care home
b) Have severe, untreated medical or physical conditions (e.g. emphysema, severe pain) that directly affect sleep
c) High risk of harm to self/others

CARE PARTNERS:
a) Severe untreated medical or physical conditions that directly affect sleep
b) Self-reported diagnosis of schizophrenia, bipolar disorder, PTSD) that directly impact sleep;
c) Fixed night shiftwork between midnight and 5 am, or rotating work schedules that require night shifts during participation.
d) A diagnosis of narcolepsy
e) High risk of harm to self/others

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
To get an idea of participants' baseline sleep characteristics, we will have a run-in period of 2 weeks in which they will use actigraphy (Phillips Respironics Actiwatch 2), complete a sleep diary and assess the Pittsburgh Sleep Quality Index (at the start of the 2 week period). PSQI will then be assessed in the main baseline questionnaire (along with other variables) to ensure participants continue to meet eligibility criteria.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE: Given the feasibility nature of this study, a convenience sample of 24 dyads will be recruited. This sample size is based on previous studies by the research team, which was deemed sufficient to trial the methodology as well as represent the diversity within dementia care.

FEASIBILITY: Evaluation of feasibility outcomes will be guided by the Consolidated Framework for Implementation Research (CFIR)20. It categorises barriers and enablers in five domains: intervention characteristics (e.g., complexity, cost), outer setting (e.g., home-based resources, barriers), inner setting (e.g., memory clinic implementation climate), characteristics of individuals (e.g., knowledge, beliefs), and implementation processes (e.g., execution, fidelity). CFIR offers a typology of determinants to support theory development about what works, where and why in the context of formative effectiveness-implementation randomised controlled trials.

PRELIMINARY EFFICACY: Changes in outcomes from baseline to post-intervention and post-intervention to follow-up will be assessed using repeated measures ANOVAs. Feasibility measures will be reported as standard scores.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2022
Actual
27/06/2022
Date of last participant enrolment
Anticipated
Actual
29/06/2023
Date of last data collection
Anticipated
Actual
19/09/2023
Sample size
Target
48
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24835 0
New Zealand
State/province [1] 24835 0

Funding & Sponsors
Funding source category [1] 309929 0
Commercial sector/Industry
Name [1] 309929 0
Dementia Centre for Research Collaboration
Country [1] 309929 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 311400 0
None
Name [1] 311400 0
Address [1] 311400 0
Country [1] 311400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309649 0
Monash University Human Ethics Research Committee (Monash Research Office)
Ethics committee address [1] 309649 0
Ethics committee country [1] 309649 0
Australia
Date submitted for ethics approval [1] 309649 0
18/10/2021
Approval date [1] 309649 0
01/12/2021
Ethics approval number [1] 309649 0
30710

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114898 0
Dr Melinda Jackson
Address 114898 0
Monash University
18 Innovation walk
Clayton 3800
VICTORIA
Country 114898 0
Australia
Phone 114898 0
+61399050206
Fax 114898 0
Email 114898 0
[email protected]
Contact person for public queries
Name 114899 0
Melinda Jackson
Address 114899 0
Monash University
18 Innovation walk
Clayton 3800
VICTORIA
Country 114899 0
Australia
Phone 114899 0
+61399050206
Fax 114899 0
Email 114899 0
[email protected]
Contact person for scientific queries
Name 114900 0
Melinda Jackson
Address 114900 0
Monash University
18 Innovation walk
Clayton 3800
VICTORIA
Country 114900 0
Australia
Phone 114900 0
+61399050206
Fax 114900 0
Email 114900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
31/12/22 - 31/12/25
Available to whom?
Researchers upon reasonable request.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Through Monash Bridges (online data repository).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMulti-modal sleep intervention for community-dwelling people living with dementia and primary caregiver dyads with sleep disturbance: protocol of a single-arm feasibility trial.2023https://dx.doi.org/10.7717/peerj.16543
N.B. These documents automatically identified may not have been verified by the study sponsor.