Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001402235p
Ethics application status
Not yet submitted
Date submitted
17/08/2018
Date registered
21/08/2018
Date last updated
20/08/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Achieving a good night's sleep using a non-pharmacological approach: a pilot trial in people with dementia and their families
Scientific title
Achieving a good night's sleep using a non-pharmacological approach: a pilot trial in people with dementia and their families
Secondary ID [1] 295840 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 309289 0
sleep disturbance 309290 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308164 308164 0 0
Occupational therapy
Neurological 308180 308180 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention incorporates aspects of Bandura’s social cognitive theory where the aim is to enhance self-efficacy of carers to be able to reduce sleep disturbance. This is achieved via:
1) Mastery experiences: where the carer is praised for the care challenges they manage well. Successes actioning components of the intervention will be highly commended by the health professional
2) Vicarious experiences: Carers will be provided with two short vignettes describing stories of success. They will also be provided with information about average sleep times in older people to help with expectations around sleep duration.
3) Verbal persuasion: Carers will be encouraged and coached by the health professional. Action planning will occur and a focus on building confidence and motivation.
4) Physiological factors: Intervention will address stress relief and the importance of carers taking time out from caring.
Session 1: Assessment of routines, environment, physical activity during the day and behaviours that may enhance or disrupt sleep overnight. Assessment of what the carer hopes for and what they have tried. Assessment of light exposure (subjective report of current levels).
Session 2: Provide summary of assessment report and possible strategies that may be beneficial. Prescription of light exposure for one hour during the morning. Health professional works with carer to develop action plan which the carer will attempt to implement . The action plan will focus on trying to establish new habits in the household routine implemented by the carer.
Session 3: Review success of implementation and strategies. Refine as needed and continue with encouragement.
Session 4: Review success of implementation and strategies. Refine as needed.

Materials:
1. Assessment report
2. Intervention package with
- Top tips for sleep hygiene
- Information sheet regarding light exposure
- Information sheet on staying calm
- Information about the benefits of physical activity
- Information about community services for people with dementia
- Vignettes describing others stories of success and average sleep times for older people
- Action plan template
Intervention will be provided by a health professional (nurse, occupational therapist or psychology graduate) with experience working with older people. Each person will be trained in the intervention and supervised for the first two cases. Ongoing supervision and mentoring will be provided.
The intervention will be provided via telehealth methods.
The clinic population will receive session 1 in their home and the remainder via videoconferencing if they have access to videoconferencing facilities (eg mobile, tablet or PC with skype or similar on).
The rural/remote population will receive all sessions via videoconferencing.
We will use the preferred program according to the participant as discussed at the time of recruitment (eg skype, facetime, zoom). Communication will mostly take place between the health professional and the family carer. Where necessary, the health professional may suggest that family send additional photos (eg photos of the person’s sleeping environment) to help with assessment and intervention.
WHERE:The health professional will be based in a clinic.
The person with dementia and their carer will remain in their homes for assessment and intervention.
Dose: Up to four sessions of approximately one hour. Provided over three weeks.
TAILORING: All intervention will be tailored depending on the person’s environment, routine and main concerns.
MODIFICATIONS: Intervention will be tailored to the needs of the person. If changes are needed to the toolkit or the action planning guide throughout the course of the study then these will be made and submitted to the ethics committee if necessary.
Fidelity to intervention will be monitored through examining treatment records (number of duration of sessions, content and action planning).
Intervention code [1] 312177 0
Behaviour
Comparator / control treatment
Usual care: The person will receive their usual services which may include visits with the GP or consultation with dementia specific services such as the National Dementia Helpline or support groups. We will not instruct the people in the control group to avoid care or doing anything differently.
Control group
Active

Outcomes
Primary outcome [1] 307132 0
Actigraphy data: mean sleep time overnight
Timepoint [1] 307132 0
3 weeks following baseline assessment
Secondary outcome [1] 350785 0
Actigraphy: REM
Timepoint [1] 350785 0
3 weeks after baseline assessment
Secondary outcome [2] 350786 0
Sleep disturbance according to sleep diary
Timepoint [2] 350786 0
3 weeks after baseline assessment
Secondary outcome [3] 350787 0
Functional Independence Measure
Timepoint [3] 350787 0
3 weeks after baseline assessment
Secondary outcome [4] 350788 0
Zarit Burden Index
Timepoint [4] 350788 0
3 weeks after baseline assessment
Secondary outcome [5] 350789 0
Mood of the person with dementia according to single question asking the person to describe their mood
Timepoint [5] 350789 0
3 weeks after baseline assessment
Secondary outcome [6] 350897 0
Actigraphy: light sleep
Timepoint [6] 350897 0
3 weeks after baseline assessment
Secondary outcome [7] 350898 0
Actigraphy: deep sleep
Timepoint [7] 350898 0
3 weeks after baseline assessment
Secondary outcome [8] 350899 0
Actigraphy: idle time
Timepoint [8] 350899 0
3 weeks after baseline assessment
Secondary outcome [9] 350900 0
Actigraphy: active time
Timepoint [9] 350900 0
3 weeks after baseline assessment

Eligibility
Key inclusion criteria
• Diagnosis of dementia provided by a medical practitioner (GP or specialist)
• Presence of cognitive impairment according to the GPCOG assessment tool (informant version)
• Person with dementia and carer must be aged 21 years or older and speak fluent English
• Lives in a private dwelling with a carer who is able to participate in the intervention and assessment.
• One or more sleep problems on the Sleep Disorders Inventory as reported by person with dementia and/or family carer
• Insomnia Severity Index score of 10 or more OR Pittsburgh Sleep Quality Index score of more than 5
• Access to videoconferencing facilities (eg skype) and a letterbox or postal box
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unlikely to remain living at home for the next three months (eg receiving palliative care or likely admission to residential care within this time period).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be managed through using sequentially numbered, opaque, sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated using an online random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Stratification based on recruitment through clinic or through advertising in rural and remote areas
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be presented descriptively due to the small sample size and aim of study to determine feasibility

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2019
Actual
Date of last participant enrolment
Anticipated
17/08/2020
Actual
Date of last data collection
Anticipated
16/11/2020
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 11687 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 23734 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300435 0
University
Name [1] 300435 0
Flinders University
Country [1] 300435 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive, Bedford Park, SA, 5042
Country
Australia
Secondary sponsor category [1] 299898 0
None
Name [1] 299898 0
Not applicable
Address [1] 299898 0
Not applicable
Country [1] 299898 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301238 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301238 0
Flinders Drive, Flinders Medical Centre, Bedford Park, SA 5042
Ethics committee country [1] 301238 0
Australia
Date submitted for ethics approval [1] 301238 0
28/08/2018
Approval date [1] 301238 0
Ethics approval number [1] 301238 0

Summary
Brief summary
The aim of this study is to test the feasibility of conducting a trial to examine the efficacy of a non-pharmacological intervention, which includes tailored intervention and exposure to light in people with dementia with sleep disturbance living in the community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86338 0
Dr Kate Laver
Address 86338 0
Rehabilitation and Palliative Care Building, Flinders Medical Centre,
Bedford Park, SA, 5042
Country 86338 0
Australia
Phone 86338 0
+61 8 7221 8335
Fax 86338 0
Email 86338 0
[email protected]
Contact person for public queries
Name 86339 0
Dr Kate Laver
Address 86339 0
Rehabilitation and Palliative Care Building, Flinders Medical Centre,
Bedford Park, SA, 5042
Country 86339 0
Australia
Phone 86339 0
+61 8 7221 8335
Fax 86339 0
Email 86339 0
[email protected]
Contact person for scientific queries
Name 86340 0
Dr Kate Laver
Address 86340 0
Rehabilitation and Palliative Care Building, Flinders Medical Centre,
Bedford Park, SA, 5042
Country 86340 0
Australia
Phone 86340 0
+61 8 7221 8335
Fax 86340 0
Email 86340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not included in the ethics application


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3896Study protocol  [email protected] Contacting researcher directly via email
3897Ethical approval  [email protected] Contacting researcher directly via email



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.