Study Results
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Basic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2021-08-18
2022-11-30
Brief Summary
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PWD ā„ 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).
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Detailed Description
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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:
1. Skill assessment checklist is used to assess the family caregivers' competence in delivering aromatherapy.
2. Logbook is used to monitor the adherence to the programme.
3. Regular consultation with consultation record form is used to monitor the feasibility, acceptance, and any adverse effect and perceived barriers to the intervention.
4. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention Group
Home-based aromatherapy programme
Home-based aromatherapy programme
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 Group
Wait-list control
Control Group
Wait-list control, no intervention for 3 weeks, then provide home-based aromatherapy
Interventions
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Home-based aromatherapy programme
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 Group
Wait-list control, no intervention for 3 weeks, then provide home-based aromatherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Li Siu Yin
Principal Investigator
Principal Investigators
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Siu Yin Li
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Individual applicants
Hong Kong, , Hong Kong
Countries
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References
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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.
Other Identifiers
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2021.335
Identifier Type: -
Identifier Source: org_study_id
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