Effectiveness of Home-based Aromatherapy for BPSD
Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons With Dementia
1 other identifier
interventional
176
1 country
1
Brief Summary
Behavioral and psychological symptoms of dementia (BPSD) is the most prominent and distressing manifestation for older persons with dementia (PWD) and caregivers. Aromatherapy was a potentially safe and effective non-pharmacological strategy in BPSD management and could provide benefits to PWD and caregivers. In Hong Kong, some Residential Care Homes for the Elderly and day care centres have provided aromatherapy service to the PWD receiving service from them. However, no such service was provided to the community-dwelling PWD living at home, which constitute a larger proportion of dementia population in HK. In addition, there is no clear implementation protocol, or formal training to the family caregivers to deliver aromatherapy to PWD in home-based setting. Therefore, this study aims to develop and evaluate the effectiveness of a home-based family caregiver-delivered aromatherapy programme for the management of BPSD. PWD ≥ 60-year-old, with BPSD symptoms, and living at home, as well as their family caregivers will be recruited. Participants who pass the screening are randomly allocated to intervention or control group. Those in the intervention group receive home-based aromatherapy programme. Those in the control group receive no intervention for 3-week control period, and then receive home-based aromatherapy programme. The outcome measures will be conducted at baseline and after the 3-week intervention/control period by using Chinese versions of Neuropsychiatric Inventory (CNPI), Chinese version of Dementia QoL Measure-Proxy (C-DEMQoL-Proxy), and Chinese version of Zarit Burden Interview (CZBI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 18, 2021
CompletedFirst Submitted
Initial submission to the registry
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFebruary 8, 2023
February 1, 2023
1.3 years
August 27, 2021
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of older persons with dementia (PWD)'s severity of BPSD as assessed by CNPI
Chinese versions of Neuropsychiatric Inventory (CNPI) is used to assess the frequency, severity, and degree of caregiver distress of 12 domains of BPSD symptoms Each domain contains one screening question, followed by 7-9 sub-questions. If the caregivers answered 'yes' or had uncertainties in the screening question, sub-questions will be used to confirm the screening question. After confirmation, the caregivers will be asked to rate the frequency (from 1 = occasionally to 4 = very frequently) and severity (from 1 = mild to 3 = severe) of symptoms, and the degree of caregiver distress (from 0 = no distress to 5 = very severe or extreme) for that domain. The total score of each domain will be calculated by multiplying the frequency by severity. The total score for the severity of BPSD symptoms will be calculated by adding the total scores for each domain; a higher score indicates higher severity of BPSD symptoms.
baseline, after 3-week intervention/ control period
Secondary Outcomes (3)
Change of PWD's quality of life as assessed by C-DEMQoL-Proxy
baseline, after 3-week intervention/ control period
Change of family caregivers' distress as assessed by CNPI
baseline, after 3-week intervention/ control period
Change of family caregivers' burden as assessed by CZBI
baseline, after 3-week intervention/ control period
Study Arms (2)
Intervention Group
EXPERIMENTALHome-based aromatherapy programme
Control Group
OTHERWait-list control
Interventions
1 hour individualised face-to-face training to family caregivers, and 3 weeks aromatherapy intervention delivered by family caregivers (aromatherapy inhalation 2 times per day, each for 1 hour, using 2 drops of Lavandula angustifolia essential oil.
Wait-list control, no intervention for 3 weeks, then provide home-based aromatherapy
Eligibility Criteria
You may qualify if:
- The PWD must satisfy the following criteria to be included in the study:
- years old or above
- residing at home
- with a diagnosis of dementia of any type and stage of severity
- presenting with at least one symptom of BPSD in the previous one month before the study
- able to communicate in Cantonese or Mandarin
- The caregivers must satisfy the following criteria to be included in the study:
- family members, partners, or relatives living with PWD
- provide unpaid daily care to PWD at home
- literate in Chinese and able to communicate in Cantonese or Mandarin.
You may not qualify if:
- PWD and their family caregivers are excluded from the study if either of them have:
- allergy or discomfort after using Lavender essential oil
- other neurological or psychological diseases besides BPSD
- the following conditions: pregnancy, breastfeeding, hypotension, exacerbation of asthma, dyspnoea, epilepsy, or glucose-6-phosphate dehydrogenase deficiency
- current use of the following drugs: anticoagulant Warfarin, antiplatelet Aspirin, central nervous system depressant, or anticonvulsant
- hate the smell of Lavender or Lavender essential oil
- PWD have received aromatherapy in the past one month
- a change in family caregiver within 1 month before the study or during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Individual applicants
Hong Kong, Hong Kong
Related Publications (1)
Li BSY, Cheung AT, Chow KM, Chan CWH. Effects of a home-based aromatherapy programme for the management of behavioural and psychological symptoms of dementia among older persons with dementia: A randomised controlled trial with process evaluation. Integr Med Res. 2025 Jun;14(2):101113. doi: 10.1016/j.imr.2024.101113. Epub 2024 Dec 2.
PMID: 40496446DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siu Yin Li
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 27, 2021
First Posted
September 2, 2021
Study Start
August 18, 2021
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
The data contain participants' privacy