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Trial registered on ANZCTR


Registration number
ACTRN12617001159347
Ethics application status
Approved
Date submitted
3/08/2017
Date registered
8/08/2017
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Essential oils for agitation in dementia (rELOAD) trial
Scientific title
The effectiveness of topical essential oils for agitation in dementia: a cluster-randomised, placebo-controlled feasibility trial
Secondary ID [1] 292590 0
None
Universal Trial Number (UTN)
U1111-1200-2881
Trial acronym
rELOAD (EssentiaL Oils for Agitation in Dementia)
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Agitation 304261 0
Dementia 304262 0
Condition category
Condition code
Neurological 303610 303610 0 0
Dementias
Mental Health 303611 303611 0 0
Other mental health disorders
Alternative and Complementary Medicine 303622 303622 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION: Participants in the intervention group will receive a bespoke blend of essential oils (4.5%) in a cream base, and a bespoke blend of essential oils (3%) in an oil base, at a dose of 20mls three times daily (for the cream), and 10 mls three times daily, as required (for the oil), for 8 consecutive weeks; the intervention will be administered topically (i.e. forearms/face/neck/shoulders for the cream [depending on participant preference], and lower legs for the oil) by trained nursing staff. Each blend will be personalised based on the participant’s odour preference, unique presentation of symptoms, and health history (including known sensitivities and contraindications to any oils or their chemical constituents). The interventions will be blended by a trained aromatherapist, who will select up to five appropriate essential oils from a list of 38 hypoallergenic oils. Fidelity will be assessed using a medication record, and by noting the remaining volume of cream in the intervention receptacle at weeks 4 (mid-intervention) and 8 (post-intervention).
Intervention code [1] 298799 0
Treatment: Other
Comparator / control treatment
CONTROL: Participants in the control group will receive control cream (cream base only) and control oil (oil base only), at a dose of 20mls three times daily (for the cream), and 10 mls three times daily, as required (for the oil), for 8 consecutive weeks; the control treatment will be administered topically (i.e. forearms/face/neck/shoulders for the cream [depending on participant preference], and lower legs for the oil) by trained nursing staff. Fidelity will be assessed using a medication record, and by noting the remaining volume of cream in the control receptacle at weeks 4 (mid-intervention) and 8 (post-intervention).
Control group
Placebo

Outcomes
Primary outcome [1] 302966 0
Mean Cohen Mansfield Agitation Inventory (CMAI) score
Timepoint [1] 302966 0
Weeks 0, 4, 8 and 10
Primary outcome [2] 302967 0
Mean Pittsburgh Agitation Scale (PAS) score
Timepoint [2] 302967 0
Weeks 0, 4, 8, and 10
Primary outcome [3] 302978 0
Study feasibility (i.e. participant recruitment and retention, response to treatment, adherence to treatment, suitability of outcome measures, operational logistics),
Timepoint [3] 302978 0
Week 10
Secondary outcome [1] 337581 0
Mean Quality of Life – Alzheimer’s Disease scale (QoL-AD) score
Timepoint [1] 337581 0
Weeks 0, 4, 8 and 10
Secondary outcome [2] 337582 0
Mean frequency of use of PRN antipsychotic medication (as reported on the PAS)
Timepoint [2] 337582 0
Weeks 0, 4, 8 and 10
Secondary outcome [3] 337584 0
Mean frequency of use of physical restraint (as reported on the PAS)
Timepoint [3] 337584 0
Weeks 0, 4, 8 and 10
Secondary outcome [4] 337588 0
Frequency of adverse events (e.g. erythema, pruritus; measured using a standardised adverse event record)
Timepoint [4] 337588 0
Weeks 1, 4 and 8 (and as required)

Eligibility
Key inclusion criteria
(1) Has been a resident of the study site for a period of at least 4 weeks.
(2) Has a diagnosis of dementia (as determined by Mini-Mental State Examination (MMSE), DSM-IV criteria or medical diagnosis).
(3) Has clinically significant agitation (as defined by a score of 39 or greater on the CMAI, or a score of 4 or greater on the Pittsburgh Agitation Scale [PAS])
(4) Can provide informed consent, both directly (if appropriate) and via their next of kin.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Concurrent exposure to essential oils in any form
(2) Concurrent exposure to other novel therapeutic interventions for agitation (e.g. Paro, Play up)
(3) History of significant head trauma or brain lesions
(4) Known allergy or sensitivity to any of the ingredients in the active or control interventions.

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)
Randomisation codes will be held in sequentially numbered opaque sealed envelopes. Each envelope will be selected by the research assistant (who will be unaware of the allocation sequence) in consecutive order at the time of site enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites will be randomly assigned to the intervention or control group, at a ratio of 1:1, using a computer-generated table of random numbers. This process will be performed by a researcher not involved in the direct administration of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
SAMPLE SIZE: As this is a feasibility trial, the purpose is not to confirm or refute hypotheses, but to determine whether investment in a larger trial is justified and feasible. A sample size of 15 patients per study arm (a total of 30 participants) will be sufficient for this purpose.

STATISTICAL ANALYSIS: Measures of central tendency and variability will be used for descriptive data where values are normally distributed. Medians and the interquartile range will be used to describe data that are not normally distributed. Frequency distributions and percentages will be used to describe categorical data. Outcome differences between groups (between-group effects), differences over time (within-subject effects) and any differential treatment effect at different points in time (interaction effects) will be examined using repeated measures analysis of variance (RM-ANOVA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 16801 0
5600 - Whyalla
Recruitment postcode(s) [2] 23586 0
5245 - Hahndorf
Recruitment postcode(s) [3] 23587 0
5238 - Mannum
Recruitment postcode(s) [4] 23588 0
5253 - Murray Bridge

Funding & Sponsors
Funding source category [1] 297166 0
University
Name [1] 297166 0
University of South Australia Department of Rural Health
Address [1] 297166 0
University of South Australia
111 Nicolson Avenue
Whyalla Norrie SA 5608
Country [1] 297166 0
Australia
Primary sponsor type
University
Name
University of South Australia Department of Rural Health
Address
University of South Australia
111 Nicolson Avenue
Whyalla Norrie SA 5608
Country
Australia
Secondary sponsor category [1] 296185 0
None
Name [1] 296185 0
Address [1] 296185 0
Country [1] 296185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298334 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 298334 0
Research and Innovation Services
Mawson Lakes Campus
University of South Australia
GPO Box 2471, Adelaide, SA, 5001
Ethics committee country [1] 298334 0
Australia
Date submitted for ethics approval [1] 298334 0
18/11/2015
Approval date [1] 298334 0
11/03/2016
Ethics approval number [1] 298334 0
0000034997

Summary
Brief summary
The behavioural and psychological symptoms of dementia (BPSD) are a constellation of distressing non-cognitive symptoms that frequently accompany dementia, affecting up to 82% of nursing home residents with the disorder. Agitation is a commonly reported BPSD, as are aggression, delusions, anxiety and depression. These symptoms can be distressing to the person with dementia and their carer, and can significantly increase the burden of care. BPSD has also been shown to increase the total annual cost of dementia care in the community by more than 30%, with 2002 estimates indicating an increase in both direct and indirect care costs of dementia care by 25% and 35%, respectively.

Antipsychotic medication continues to be the primary mode of treatment for BPSD; this is despite reservations about the clinical effectiveness and safety of these agents for BPSD. A 7-tiered BPSD management model was proposed in 2003 in an attempt to improve the management of BSPD, and to reduce antipsychotic use. In the lower tiers of the model, non-pharmacological treatment is recommended as first-line management, with antipsychotics only indicated as a `last resort' if symptoms cause severe distress or an immediate risk of harm to the patient or others.

In light of these recommendations, as well as concerns regarding the cost, safety and effectiveness of antipsychotic medication for the management of BPSD, many carers and health providers are turning to the use of non-pharmacological therapies to manage agitation and other BPSD. One such approach that is receiving increasing attention in the literature because of its purported safety, low-cost, high level of acceptance and ease of implementation, is aromatherapy.

Aromatherapy is the therapeutic administration of plant essential oils via inhalation or topical application. Empirical evidence suggests that essential oils may assist in the management of agitation and BPSD by acting on the neurolimbic system, and by upregulating neurotransmitter synthesis to generate antidepressant, anxiolytic and sedative effects. Despite essential oils being a biologically plausible, low-cost and well-tolerated treatment for BPSD, current evidence of effectiveness is conflicting, with some calling for higher-quality, longer-term trials. In response to these recommendations, researchers at the University of South Australia Department of Rural Health will be conducting a cluster-randomised, placebo-controlled feasibility trial to explore whether topically-administered, individualised essential oil preparations are effective in alleviating agitation in persons with dementia. The 10-week trial will be implemented across two residential aged care facilities in regional South Australia, and is hoping to recruit at least 30 residents with dementia. Findings from this trial will determine the feasibility of conducting a large effectiveness trial of essential oils for agitation in dementia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76754 0
Dr Matthew Leach
Address 76754 0
Department of Rural Health
University of South Australia
111 Nicolson Avenue
Whyalla Norrie, SA, 5608
Country 76754 0
Australia
Phone 76754 0
+61 8 8302 2413
Fax 76754 0
Email 76754 0
matthew.leach@unisa.edu.au
Contact person for public queries
Name 76755 0
Dr Matthew Leach
Address 76755 0
Department of Rural Health
University of South Australia
111 Nicolson Avenue
Whyalla Norrie, SA, 5608
Country 76755 0
Australia
Phone 76755 0
+61 8 8302 2413
Fax 76755 0
Email 76755 0
matthew.leach@unisa.edu.au
Contact person for scientific queries
Name 76756 0
Dr Matthew Leach
Address 76756 0
Department of Rural Health
University of South Australia
111 Nicolson Avenue
Whyalla Norrie, SA, 5608
Country 76756 0
Australia
Phone 76756 0
+61 8 8302 2413
Fax 76756 0
Email 76756 0
matthew.leach@unisa.edu.au

No data has been provided for results reporting
Summary results
Not applicable