ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

dementia

sleep disturbance

Condition category

Condition code

Physical Medicine / Rehabilitation

Occupational therapy

Neurological

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]

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]

Actigraphy data: mean sleep time overnight

Timepoint [1]

3 weeks following baseline assessment

Secondary outcome [1]

Actigraphy: REM

Timepoint [1]