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Trial registered on ANZCTR


Registration number
ACTRN12621000260820p
Ethics application status
Submitted, not yet approved
Date submitted
6/11/2020
Date registered
10/03/2021
Date last updated
10/03/2021
Date data sharing statement initially provided
10/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing a sleep program for caregivers of people living with dementia
Scientific title
Feasibility and acceptability of a sleep hygiene intervention study in caregivers of people living with dementia.
Secondary ID [1] 302731 0
RM Gibson–G1005015
Universal Trial Number (UTN)
U1111-1260-6547
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor sleep 319663 0
Depression 319664 0
Anxiety 319665 0
Stress 320958 0
Caregiver Burden 321012 0
Condition category
Condition code
Mental Health 317591 317591 0 0
Other mental health disorders
Mental Health 317592 317592 0 0
Depression
Mental Health 317593 317593 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to develop and implement a tailored sleep hygiene education program for caregivers of community dwelling people living with dementia (PLWD). Prior to delivery of the pilot intervention, this stage of the project will assess the feasibility and acceptability of the intervention to caregivers of people living with dementia.
Potential participants will be provided with a Patient Information Statement, a flyer detailing the sleep program, and a consent form. Participants will be provided with an actigraph that records sleep, and a sleep diary one week prior to the intervention.
CBT-I materials will be provided by ECU Psychological Services Centre.
The “Sleeping Better” program has run for the last 4 years at the Edith Cowan University (ECU) Psychological Services Centre. The mode of delivery is face to face in 4 x 2-hour sessions, once a week for 4 weeks. Sessions will be conducted in groups of 6-8 persons; however, the same program will be delivered to all participants by the same person.
Weekly sessions cover:
(1) sleep education
(2) sleep hygiene
(3) strategies for worrying and intrusive thoughts and;
(4) relaxation techniques.
The program will be delivered by ECU clinical psychology students as part of their clinical placement at the ECU Psychological Services Centre, under the supervision of an experienced Clinical Psychologist who will also work with the Principal investigator to incorporate content relevant to carers of PLWD into their existing sleep intervention program.
The intervention will be delivered at the ECU Psychological Services Centre in Wanneroo, Western Australia.
Feasibility will be determined by the number of participants expressing an interest to enroll and the drop out/non-attendance rate (feasibility of recruitment and retention). Feasibility of measurement tools will also be assessed in regards to time taken to fill out tools, missing data and completion of post-intervention follow up questionnaires. Acceptability of adherence and coherence to the intervention will be assessed by evaluating number of sessions attended and sleep log completion. A post intervention focus group will also determine acceptability of the intervention where participants will be asked to discuss the burden and barriers of attending, their adherence to the program and their satisfaction with the program. Focus group feedback from the initial feasibility study will ensure the program is adapted and delivered in a way which is appropriate, applicable and meaningful to dementia carers. Therefore, modifications to the feasibility stage intervention may be necessary based on the outcome of the feasibility study and focus groups.
Intervention code [1] 319013 0
Lifestyle
Comparator / control treatment
In the feasibility study phase, there will not be any comparators.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325638 0
Feasibility
This will be assessed via:
- Number of participants recruited. Following recruitment advertising, we will determine the number of potential participants that express an interest in partaking in the intervention. We will also record the number of participants who enroll and then complete the full intervention and data collection.
-Feasibility of tools including time taken to complete the tools, any missing data and the follow up response rate.
Timepoint [1] 325638 0
Post intervention analyses of intervention data.
Post intervention focus group to take place approximately one week after the final intervention session.
Primary outcome [2] 325639 0
Acceptability
This will be assessed via:
-Focus group data will inform barriers and burdens associated with partaking in the intervention.
- Intervention adherence via session attendance and adoption of learned technique.
-Experience and satisfaction of intervention
Timepoint [2] 325639 0
Post intervention analyses of intervention data.
Post intervention focus group to take place approximately one week after the final intervention session.
Secondary outcome [1] 388631 0
Subjective measurement of psychological wellbeing by the Depression Anxiety and Stress Scale (DASS-21)
Timepoint [1] 388631 0
Pre intervention assessment of psychological wellbeing
Immediate post intervention assessment of wellbeing (within 1 week of intervention) and
Follow up intervention of wellbeing (3 months post intervention)n
Secondary outcome [2] 392462 0
Changes in objectively and subjectively measured sleep.
Objectively measured sleep data will be obtained via actigraphy-measured sleep.
Subjectively measured sleep data will be obtained by participant self-report by sleep diaries and the Pittsburgh Sleep Quality Index tool (PSQI)
Timepoint [2] 392462 0
Pre intervention assessment of sleep
Immediate post intervention assessment of sleep (within 1 week of intervention) and
Follow up intervention of sleep (3 months post intervention)
Secondary outcome [3] 392617 0
Subjective measurement of Caregiver Burden via validated Caregiver Burden Scale
Timepoint [3] 392617 0
Pre intervention assessment of psychological wellbeing
Immediate post intervention assessment of wellbeing (within 1 week of intervention) and
Follow up intervention of wellbeing (3 months post intervention)

Eligibility
Key inclusion criteria
Informal caregivers (i.e. spouse or other family member, or friend who provides more than 8 hours a week of unpaid care) of a community-dwelling person living with dementia; self-identified sleep disturbances
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing diagnosis of sleep apnea/sleep disordered breathing.
Taking sleep medication more than once per week regularly.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is primarily an acceptability and feasibility study the analysis will focus on the key parameters necessary for conducting a future trial. Most of the analysis will be
descriptive in nature. Feasibility will be determined by assessing the recruitment process (number of participants referred, number of people attending the intervention) and
also the measurement tools (by recording the time for filling in the questionnaires, number of items missing and the follow-up rates). Acceptability analysis will be primarily descriptive in nature, with this data collected in follow up post-interventional focus groups. Given the small number of participants within the feasibility phase, statistical analyses of the secondary outcomes will not be statistically sound and therefore data will be described descriptively which will provide some insight into the potential benefits of the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
Date of last participant enrolment
Anticipated
3/05/2021
Actual
Date of last data collection
Anticipated
31/07/2021
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 31926 0
6027 - Joondalup
Recruitment postcode(s) [2] 31927 0
6065 - Wanneroo

Funding & Sponsors
Funding source category [1] 307156 0
University
Name [1] 307156 0
Edith Cowan University
Country [1] 307156 0
Australia
Funding source category [2] 307158 0
Charities/Societies/Foundations
Name [2] 307158 0
RM Gibson Research Fund Grant
Country [2] 307158 0
Australia
Primary sponsor type
Individual
Name
Dr Aisling Smyth
Address
Edith Cowan University
School of Nursing and Midwifery
270 Joondalup Drive
Joondalup
Western Australia 6027
Country
Australia
Secondary sponsor category [1] 307746 0
Individual
Name [1] 307746 0
Prof Evalotte Morelius
Address [1] 307746 0
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country [1] 307746 0
Australia
Secondary sponsor category [2] 307748 0
Individual
Name [2] 307748 0
Ms Eimear Quigley
Address [2] 307748 0
ECU Psychological Services Centre
Level 2 ECU Health Centre
30 Dundebar Rd
Wanneroo
Western Australia 6065
Country [2] 307748 0
Australia
Other collaborator category [1] 281528 0
Individual
Name [1] 281528 0
Ms Melissa Dunham
Address [1] 281528 0
Edith Cowan University
School of Nursing and Midwifery
270 Joondalup Drive
Joondalup
Western Australia 6027
Country [1] 281528 0
Australia
Other collaborator category [2] 281678 0
University
Name [2] 281678 0
Ms Eimear Quigley
Address [2] 281678 0
ECU Psychological Services,
Level 2 ECU Health Centre,
30 Dundebar Rd,
Wanneroo
WA 6065
Country [2] 281678 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307272 0
Edith Cowan University HREC Committee
Ethics committee address [1] 307272 0
Ethics committee country [1] 307272 0
Australia
Date submitted for ethics approval [1] 307272 0
30/09/2020
Approval date [1] 307272 0
Ethics approval number [1] 307272 0

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

Contacts
Principal investigator
Name 106638 0
Dr Aisling Smyth
Address 106638 0
Edith Cowan University
School of Nursing and Midwifery,
270 Joondalup Drive,
Joondalup,
Western Australia 6027
Country 106638 0
Australia
Phone 106638 0
+61 863043533
Fax 106638 0
Email 106638 0
aisling.smyth@ecu.edu.au
Contact person for public queries
Name 106639 0
Aisling Smyth
Address 106639 0
Edith Cowan University
School of Nursing and Midwifery,
270 Joondalup Drive,
Joondalup,
Western Australia 6027
Country 106639 0
Australia
Phone 106639 0
+61 863043533
Fax 106639 0
Email 106639 0
aisling.smyth@ecu.edu.au
Contact person for scientific queries
Name 106640 0
Aisling Smyth
Address 106640 0
Edith Cowan University
School of Nursing and Midwifery,
270 Joondalup Drive,
Joondalup,
Western Australia 6027
Country 106640 0
Australia
Phone 106640 0
+61 863043533
Fax 106640 0
Email 106640 0
aisling.smyth@ecu.edu.au

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 data will be available to share in its anonymised/de-identified form
When will data be available (start and end dates)?
Post publication of the results, available for 5 years post publication
Available to whom?
Case by Case basis at the discretion of the PI
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approval by PI
Dr Aisling Smyth
aisling.smyth@ecu.edu.au


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
No additional documents have been identified.