Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000056392
Ethics application status
Approved
Date submitted
15/12/2016
Date registered
11/01/2017
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility trial comparing a behavioural intervention, melatonin and usual care for people with dementia and sleep disturbance
Scientific title
A feasibility trial comparing a behavioural intervention, melatonin and usual care for people with dementia and sleep disturbance
Secondary ID [1] 290772 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
dementia 301369 0
Sleep disturbance 301521 0
Condition category
Condition code
Neurological 301122 301122 0 0
Dementias
Physical Medicine / Rehabilitation 301242 301242 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Melatonin: People allocated to the melatonin intervention will be provided with melatonin which will be sourced from compounding pharmacies. We will provide a low dose (3mg), non-sustained release preparation. Participants will be asked to take the melatonin one hour before the desired bedtime with a small amount of water. Melatonin will be taken daily for 8 weeks.
Arm 2: Behavioural intervention: Participants receiving the behavioural intervention will receive four consultations with an occupational therapist. The occupational therapist will problem solve with the carer to develop a management plan incorporating sleep hygiene advice. The four consultations lasting up to one hour will be provided over a maximum of a 4 week period. The first consultation will take place in the home and remaining consultations may take place in the home or over the phone depending on client needs. Treatment records written by the occupational therapist will be used to examine adherence to the intervention protocol and to describe the intervention provided. Additional fidelity checks will not be undertaken.
Intervention code [1] 296679 0
Treatment: Drugs
Intervention code [2] 296680 0
Behaviour
Intervention code [3] 296781 0
Treatment: Other
Comparator / control treatment
Arm 3: Usual care. Usual care means that the person will continue with existing arrangements for their health care. There are no restrictions in terms of the care that they access during the study period.
Control group
Active

Outcomes
Primary outcome [1] 300527 0
Activity measured using an activity monitoring system (fitbit device) which will be worn on the persons wrist and provides information about activity during the day as well as rest and sleep patterns.
Timepoint [1] 300527 0
Start of Week 8 (measured over a seven day period)
Secondary outcome [1] 330223 0
Sleep diary (measuring time in bed, lights out, asleep, waking and out of bed) which will be completed by the carer
Timepoint [1] 330223 0
8 weeks (diary to be completed every day for the 8 week duration of the study).
Secondary outcome [2] 330224 0
Insomnia severity index completed by the participant
Timepoint [2] 330224 0
8 weeks
Secondary outcome [3] 330225 0
OSA50 questionnaire measuring risk of sleep apnea (completed by the participant in conjunction with the carer).
Timepoint [3] 330225 0
8 weeks
Secondary outcome [4] 330226 0
objective screening for OSA with ApneaLink (outcome is presence of OSA or not).
Timepoint [4] 330226 0
8 weeks
Secondary outcome [5] 330227 0
Caregiver burden measured using the Zarit Burden Interview. Completed by the caregiver.
Timepoint [5] 330227 0
8 weeks
Secondary outcome [6] 330228 0
Geriatric Depression Scale
Timepoint [6] 330228 0
8 weeks

Eligibility
Key inclusion criteria
- Diagnosis of dementia provided by a medical practitioner (GP or specialist)
- MMSE score of less than 24/30
- Must be aged 21 years or older and speak fluent English
- Lives in a private dwelling with a carer
- One or more sleep problems on the Sleep Disorders Inventory
- No contraindications to taking melatonin (assessed by the treating medical team at the hospital)
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life expectancy limited to less than nine months, autoimmune disorder or kidney or liver disease

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)
Online sealed envelope software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will recruit 30 participants to this feasibility trial, randomising 10 participants to each group. This trial examines feasibility to inform a larger study so between group analyses will examine whether there are positive effects and the effect size.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
As previous, the release of clinical guidelines recommending not to use the intervention meant that the study needed to be amended. We have withdrawn this study from the ethics committee and will re-design a study in line with the most recent knowledge and recommendations.
Date of first participant enrolment
Anticipated
15/01/2018
Actual
Date of last participant enrolment
Anticipated
30/01/2019
Actual
Date of last data collection
Anticipated
30/03/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9985 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 14916 0
5041 - Daw Park
Recruitment postcode(s) [2] 18823 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 295192 0
University
Name [1] 295192 0
Flinders University
Country [1] 295192 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 294020 0
None
Name [1] 294020 0
None
Address [1] 294020 0
None
Country [1] 294020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296544 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 296544 0
Flinders Medical Centre, Flinders Drive, Bedford Park, SA, 5042
Ethics committee country [1] 296544 0
Australia
Date submitted for ethics approval [1] 296544 0
15/07/2016
Approval date [1] 296544 0
04/10/2016
Ethics approval number [1] 296544 0
OFR 314.16 - HREC/16/SAC/263

Summary
Brief summary
The aim of this study is to determine the feasibility of running a randomised controlled trial in which participants with dementia and sleep disturbance are randomised to either participation in a behavioural intervention (sleep hygiene program), taking melatonin or usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71234 0
Dr Kate Laver
Address 71234 0
Flinders University, GPO Box 2100, Adelaide SA, 5001
Country 71234 0
Australia
Phone 71234 0
+61 8 7221 8335
Fax 71234 0
Email 71234 0
Kate.Laver@flinders.edu.au
Contact person for public queries
Name 71235 0
Dr Kate Laver
Address 71235 0
Flinders University, GPO Box 2100, Adelaide SA, 5001
Country 71235 0
Australia
Phone 71235 0
+61 8 8276 9666
Fax 71235 0
Email 71235 0
Kate.Laver@flinders.edu.au
Contact person for scientific queries
Name 71236 0
Dr Kate Laver
Address 71236 0
Flinders University, GPO Box 2100, Adelaide SA 5000
Country 71236 0
Australia
Phone 71236 0
+61 8 8276 9666
Fax 71236 0
Email 71236 0
Kate.Laver@flinders.edu.au

No information has been provided regarding IPD availability


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.