Effectiveness of Home-based Aromatherapy for BPSD (NCT05032664) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Home-based Aromatherapy for BPSD
Hong Kong176 participantsStarted 2021-08-18
Plain-language 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).
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The PWD must satisfy the following criteria to be included in the study:
* 60 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.
Exclusion Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of older persons with dementia (PWD)'s severity of BPSD as assessed by CNPI
Timeframe: baseline, after 3-week intervention/ control period