Essential oils for agitation in dementia (rELOAD) trial

Not Applicable

Completed

• Conditions: Agitation; Dementia; Neurological - Dementias; Mental Health - Other mental health disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12617001159347
• Lead Sponsor: niversity of South Australia Department of Rural Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Study Completion: 2018-12-14
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Cohen Mansfield Agitation Inventory (CMAI) score[Weeks 0, 4, 8 and 10];Mean Pittsburgh Agitation Scale (PAS) score[Weeks 0, 4, 8, and 10];Study feasibility (i.e. participant recruitment and retention, response to treatment, adherence to treatment, suitability of outcome measures, operational logistics), [Week 10]

Secondary Outcome Measures

Name	Time	Method
Mean Quality of Life – Alzheimer’s Disease scale (QoL-AD) score[Weeks 0, 4, 8 and 10];Mean frequency of use of PRN antipsychotic medication (as reported on the PAS)[Weeks 0, 4, 8 and 10];Mean frequency of use of physical restraint (as reported on the PAS)[Weeks 0, 4, 8 and 10];Frequency of adverse events (e.g. erythema, pruritus; measured using a standardised adverse event record)[Weeks 1, 4 and 8 (and as required)]