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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

19/07/2019

Date data sharing statement initially provided

19/07/2019

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]

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

Dementia

Condition category

Condition code

Neurological

Dementias

Mental Health

Other mental health disorders

Alternative and Complementary Medicine

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]

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]

Mean Cohen Mansfield Agitation Inventory (CMAI) score

Timepoint [1]

Weeks 0, 4, 8 and 10

Primary outcome [2]

Mean Pittsburgh Agitation Scale (PAS) score

Timepoint [2]

Weeks 0, 4, 8, and 10

Primary outcome [3]

Study feasibility (i.e. participant recruitment and retention, response to treatment, adherence to treatment, suitability of outcome measures, operational logistics),

Timepoint [3]

Week 10

Secondary outcome [1]

Mean Quality of Life – Alzheimer’s Disease scale (QoL-AD) score

Timepoint [1]

Weeks 0, 4, 8 and 10

Secondary outcome [2]

Mean frequency of use of PRN antipsychotic medication (as reported on the PAS)

Timepoint [2]

Weeks 0, 4, 8 and 10

Secondary outcome [3]

Mean frequency of use of physical restraint (as reported on the PAS)

Timepoint [3]

Weeks 0, 4, 8 and 10

Secondary outcome [4]

Frequency of adverse events (e.g. erythema, pruritus; measured using a standardised adverse event record)

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

9/10/2017

Actual

2/01/2018

Date of last participant enrolment

Anticipated

10/08/2018

Actual

14/09/2018

Date of last data collection

Anticipated

31/10/2018

Actual

14/12/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5600 - Whyalla

Recruitment postcode(s) [2]

5245 - Hahndorf

Recruitment postcode(s) [3]

5238 - Mannum

Recruitment postcode(s) [4]

5253 - Murray Bridge

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia Department of Rural Health

Address [1]

University of South Australia
111 Nicolson Avenue
Whyalla Norrie SA 5608

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

Research and Innovation Services
Mawson Lakes Campus 
University of South Australia 
GPO Box 2471, Adelaide, SA, 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/11/2015

Approval date [1]

11/03/2016

Ethics approval number [1]

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

Dr Matthew Leach

Address

Department of Rural Health
University of South Australia
111 Nicolson Avenue
Whyalla Norrie, SA, 5608

Country

Australia

Phone

+61 8 8302 2413

Fax

[email protected]

Contact person for public queries

Name

Matthew Leach

Address

Department of Rural Health
University of South Australia
111 Nicolson Avenue
Whyalla Norrie, SA, 5608

Country

Australia

Phone

+61 8 8302 2413

Fax

[email protected]

Contact person for scientific queries

Name

Matthew Leach

Address

Department of Rural Health
University of South Australia
111 Nicolson Avenue
Whyalla Norrie, SA, 5608

Country

Australia

Phone

+61 8 8302 2413

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Participants did not consent to their data being used by third parties, or to undergo analysis beyond that stipulated in the approved protocol.

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

Source	Title	Year of Publication	DOI
Embase	Aromatherapy for dementia.	2020	https://dx.doi.org/10.1002/14651858.CD003150.pub3
Embase	Essential oils for agitation in dementia [rELOAD]: A pragmatic, cluster-randomized, placebo-controlled, pilot feasibility trial.	2021	https://dx.doi.org/10.1016/j.imr.2021.100747

N.B. These documents automatically identified may not have been verified by the study sponsor.

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