Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia (SENSE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Feasibility and acceptability of an olfactory enrichment program in improving the well-being of patients with mild cognitive impairment (MCI) and dementia.
研究概览
简要总结
To determine if diffusion aromatherapy exposure to an essential oil blend can potentially improve mild cognitive impairment/mild dementia symptoms and relieve caregiver stress.
This study also allows us to gauge the willingness of elderly patients in complying with long-term aromatherapy treatments.
详细描述
SENSE is a non-blinded study that aims to recruit 200 participants, consisting of 200 patients with MCI or mild dementia, along with their respective caregivers. Participants will be recruited from the Geriatric Clinic and Psychology Clinic in Sengkang General Hospital, in either English or Chinese. Participants are randomized into the control and intervention group, in which the latter will receive an aromatherapy diffuser, a proprietary aromatic asian plant extract (AAPE) as an essential oil blend to add into the diffuser, and an aromatherapy diary to fill up for 6 months. The participants of the intervention group are to diffuse the essential oils twice daily for a minimum of 5 minutes each session, and will also receive phone calls at the 2, 4, 6, 8, 16, and 20th week timepoint to check on compliance and adverse events.
Both the control and intervention group will complete questionnaires on the first visit, mid-intervention visit (12th week timepoint) and final visit (24th week timepoint):
Patients:
- Patient Baseline Data Collection Form (only for first visit)
- Singapore Version of Montreal Cognitive Assessment (MoCA)
- Cornell Scale for Depression in Dementia (CSDD)
- Rating Anxiety in Dementia (RAID)
- Sniffin' Sticks Olfactory Test (only for first and final visit)
Caregivers:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients:
- •Aged 50 years old and above.
- •Confirmed diagnosis of MCI or mild dementia based on clinical records.
- •Has one identified caregiver aged 21 years and above who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study intervention.
- •For caregivers:
- •Aged 21 years old and above.
- •Willing and able to provide written informed consent
- •Identified as the caregiver for recruited patient in this study can read, understand, and speak the designated language at the study site; either lives with the recruited patients or sees the patient for ≥2 hours/day ≥3 days/week.
- •Agrees to accompany the patient to each study visit; and can verify daily compliance with study intervention.
排除标准
- •For patients:
- •Olfactory impaired/dysfunctional.
- •Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations.
- •Has Reactive Airway Disease (e.g, Asthma).
- •Participant without a caregiver.
- •Pregnant, breastfeeding, or intending to conceive during study period.
- •For caregivers:
- •Physically or mentally incapable of providing verbal / written consent
- •Does not have regular or meaningful contact with the participant (e.g. less than 2 hours/day or less than 3 days/week).
- •Not able to follow patient to each study visit.
研究组 & 干预措施
Intervention Group
干预措施: Aromatherapy (Other)
结局指标
主要结局
Feasibility and acceptability of an olfactory enrichment program in improving the well-being of patients with mild cognitive impairment (MCI) and dementia.
时间窗: Mid-intervention (12 weeks), and post intervention (24 weeks).
To gauge the compliance and willingness to comply with long-term aromatherapy treatments in their homes, in a local context. Compliance rate will be calculated using the total number of sessions that the participants have fulfilled, for at least 5 minutes each session. Patients that are unable to meet the minimum of 50% compliance will be withdrawn from the study.
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Rating Anxiety in Dementia (RAID) Questionnaire.
时间窗: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
RAID utilizes a scale that includes "unable to evaluate" and 0-3. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of anxiety.
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Cornell Scale for Depression in Dementia (CSDD) Questionnaire.
时间窗: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
CSDD utilizes a scale that includes "absent" and 0-2. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of depressive symptoms.
次要结局
- Preliminary efficacy of the intervention in maintaining cognitive function in patients with MCI and dementia.(Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).)
- Impact of the intervention on caregiver stress and burden via Neuropsychiatric Inventory Questionnaire (NPI-Q)(Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).)
- Impact of the intervention on caregiver stress and burden via ZBI-12 (Zarit Caregiver Burden Assessment)(Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).)