Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Change of older persons with dementia (PWD)'s severity of BPSD as assessed by CNPI
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
Home-based aromatherapy programme
干预措施: Home-based aromatherapy programme (Other)
Control Group
Wait-list control
干预措施: Control Group (Other)
结局指标
主要结局
Change of older persons with dementia (PWD)'s severity of BPSD as assessed by CNPI
时间窗: 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.
次要结局
- 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)
研究者
Li Siu Yin
Principal Investigator
Chinese University of Hong Kong