Behavioural and Psychiatric Symptoms of DementiaNCT05032664
Effectiveness of Home-based Aromatherapy for BPSD
A study testing Home-based aromatherapy programme in people with Behavioural and Psychiatric Symptoms of Dementia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Behavioural and Psychiatric Symptoms of Dementia
- What is being tested?
- Home-based aromatherapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Aug 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons With Dementia
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).
Read the detailed description
Study Aim and Objectives:
This study aims to develop and evaluate the effectiveness of a home-based family caregiver-delivered aromatherapy programme for the management of BPSD.
The objectives are to evaluate the effectiveness of the programme in improving PWD's severity of BPSD symptoms and QoL, and decreasing family caregivers' distress and burden.
Study Design and Setting:
This study is a RCT with two-armed single-blinded parallel design conducted in the participants' homes.
Intervention Group: Home-based Aromatherapy Programme After baseline assessment, an evidence-based theory-driven home-based aromatherapy programme will be conducted in intervention group.
Control Group: Wait-list Control After baseline assessment, no intervention will be provided to the control group for a 3-week control period. Afterwards, individualised face-to-face training will be provided to the family caregivers, and aromatherapy materials will be provided for delivering home-based aromatherapy intervention on PWD.
Study Outcomes:
The primary outcome is the change in PWD's severity of BPSD symptoms. The secondary outcomes are the changes in PWD's QoL, and family caregivers' distress and burden.
Process Evaluation:
Process evaluation will be performed in intervention group by:
- Skill assessment checklist is used to assess the family caregivers' competence in delivering aromatherapy.
- Logbook is used to monitor the adherence to the programme.
- Regular consultation with consultation record form is used to monitor the feasibility, acceptance, and any adverse effect and perceived barriers to the intervention.
- 15-20 minutes semi-structured individual interview with an interview guide to family caregivers after intervention is used to evaluate the feasibility, acceptability, and perceived benefit and limitation of the programme.
Data Analysis Plan
Analysis of Quantitative Data:
The normality of continuous variables will be assessed by using z-test for skewness and kurtosis. Skewness and kurtosis statistics are less reliable in sample size of less than 300 because they could not adjust the standard error; therefore, z-test will be applied for normality test using skewness and kurtosis. The homogeneity of the baseline data between the intervention and control groups, and between the participants who have completed the study and those do not, will be analysed using independent-sample t-test, Mann-Whitney U test, Pearson chi-square test, or Fisher's exact test depending on the type and normality of the data. The outcome variables are expressed as continuous variables. The differential changes of outcomes between groups and across time will be evaluated by generalized estimating equation (GEE) models.
Analysis of Qualitative Data:
The qualitative data will be analysed by conventional content analysis. They will be read repeatedly to derive codes. The codes will then be sorted into different subcategories by inductive method. Then, the subcategories will be combined to form categories based on the relationships between subcategories. Finally, all the categories, subcategories and codes will be determined after discussion within the research team.
- Being tested
- Home-based aromatherapy programme, Control Group
- Keywords
- BPSD, Dementia, Aromatherapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based aromatherapy programmeOther
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.
Control GroupOther
Wait-list control, no intervention for 3 weeks, then provide home-based aromatherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Home-based aromatherapy programme Receives: Other: Home-based aromatherapy programme |
| Control Group | Other | Wait-list control Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after 3-week intervention/ control period
Secondary outcomes (3)
Change of PWD's quality of life as assessed by C-DEMQoL-Proxy
Chinese version of Dementia Quality of Life Measure - Proxy (DEMQoL-Proxy) is a 31-item caregiver-reported questionnaire used to measure the quality of life (QoL) of PWD by assessing the feelings, memory, and daily life. Each item is rated in a four-point Likert scale (from 1 = a lot to 4 = not at all), with a total score ranging from 31 to 124, and a higher score indicating better QoL.
Measured: baseline, after 3-week intervention/ control period
Change of family caregivers' distress as assessed by CNPI
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 caregiver distress score will be calculated separately by adding the individual caregiver distress score for each domain; a higher score indicates higher caregiver distress
Measured: baseline, after 3-week intervention/ control period
Change of family caregivers' burden as assessed by CZBI
Chinese version of Zarit Burden Interview (CZBI) contains 22 items to assess the subjective burden reported by the caregivers of PWD. Each item is rated by a five-point Likert scale ranging from 0 = never to 4 = nearly always for the first 21 items, and from 0 = not at all to 4 = extremely for the last item, with a total score ranging from 0 to 88, and a higher score indicating higher caregiver burden.
Measured: baseline, after 3-week intervention/ control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start18 Aug 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioural and Psychiatric Symptoms of DementiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Siu Yin, Chinese University of Hong Kong
- Investigators
- Siu Yin Li, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032664
- Sponsor's protocol ID
- 2021.335
- Status last verified
- Feb 2023
- First submitted
- 27 Aug 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data contain participants' privacy
Publications
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.
PubMed 40496446
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons With Dementia
- ClinicalTrials.gov ID
- NCT05032664
- Acronym / sponsor ID
- 2021.335
- Keywords
- BPSD, Dementia, Aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study Aim and Objectives:
This study aims to develop and evaluate the effectiveness of a home-based family caregiver-delivered aromatherapy programme for the management of BPSD.
The objectives are to evaluate the effectiveness of the programme in improving PWD's severity of BPSD symptoms and QoL, and decreasing family caregivers' distress and burden.
Study Design and Setting:
This study is a RCT with two-armed single-blinded parallel design conducted in the participants' homes.
Intervention Group: Home-based Aromatherapy Programme After baseline assessment, an evidence-based theory-driven home-based aromatherapy programme will be conducted in intervention group.
Control Group: Wait-list Control After baseline assessment, no intervention will be provided to the control group for a 3-week control period. Afterwards, individualised face-to-face training will be provided to the family caregivers, and aromatherapy materials will be provided for delivering home-based aromatherapy intervention on PWD.
Study Outcomes:
The primary outcome is the change in PWD's severity of BPSD symptoms. The secondary outcomes are the changes in PWD's QoL, and family caregivers' distress and burden.
Process Evaluation:
Process evaluation will be performed in intervention group by:
- Skill assessment checklist is used to assess the family caregivers' competence in delivering aromatherapy.
- Logbook is used to monitor the adherence to the programme.
- Regular consultation with consultation record form is used to monitor the feasibility, acceptance, and any adverse effect and perceived barriers to the intervention.
- 15-20 minutes semi-structured individual interview with an interview guide to family caregivers after intervention is used to evaluate the feasibility, acceptability, and perceived benefit and limitation of the programme.
Data Analysis Plan
Analysis of Quantitative Data:
The normality of continuous variables will be assessed by using z-test for skewness and kurtosis. Skewness and kurtosis statistics are less reliable in sample size of less than 300 because they could not adjust the standard error; therefore, z-test will be applied for normality test using skewness and kurtosis. The homogeneity of the baseline data between the intervention and control groups, and between the participants who have completed the study and those do not, will be analysed using independent-sample t-test, Mann-Whitney U test, Pearson chi-square test, or Fisher's exact test depending on the type and normality of the data. The outcome variables are expressed as continuous variables. The differential changes of outcomes between groups and across time will be evaluated by generalized estimating equation (GEE) models.
Analysis of Qualitative Data:
The qualitative data will be analysed by conventional content analysis. They will be read repeatedly to derive codes. The codes will then be sorted into different subcategories by inductive method. Then, the subcategories will be combined to form categories based on the relationships between subcategories. Finally, all the categories, subcategories and codes will be determined after discussion within the research team.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Home-based aromatherapy programmeHome-based aromatherapy programme |
| Control Group | Other | Other: Control GroupWait-list control |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based aromatherapy programme1 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. | Other | Intervention Group |
| Control GroupWait-list control, no intervention for 3 weeks, then provide home-based aromatherapy | Other | Control Group |
Primary outcome
Change of older persons with dementia (PWD)'s severity of BPSD as assessed by CNPI
Time frame: baseline, after 3-week intervention/ control period
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.
3 secondary outcomes
Change of PWD's quality of life as assessed by C-DEMQoL-Proxy
Time frame: baseline, after 3-week intervention/ control period
Change of family caregivers' distress as assessed by CNPI
Time frame: baseline, after 3-week intervention/ control period
Change of family caregivers' burden as assessed by CZBI
Time frame: baseline, after 3-week intervention/ control period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 40496446Li 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.
- Individual participant dataSharing planned: No. The data contain participants' privacy
Related trials for Behavioural and Psychiatric Symptoms of Dementia
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Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siu Yin Li principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based aromatherapy programme in people with Behavioural and Psychiatric Symptoms of Dementia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of older persons with dementia (PWD)'s severity of BPSD as assessed by CNPI (time frame: baseline, after 3-week intervention/ control period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.