You, Me and Nature: A Randomised Pilot Study of a Manualised, Caregiver-led Nature-based Intervention to Improve the Wellbeing of People Living With Mild Cognitive Impairment or Dementia and Their Supporters or Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in wellbeing of the person living with dementia or mild cognitive impairment and their caregiver
研究概览
简要总结
Background: Nature positively affects people living with dementia. However, there are a lack of nature-based interventions for people living with mild cognitive impairment or dementia who reside in the community.
Aim: This study is testing a caregiver-led nature-based intervention, which has been co-developed with people living with dementia, supporters/caregivers and professionals, and the study design and set-up will also be evaluated. The results will help provide evidence for whether or not to carry out a larger study in the future and will also contribute to the evidence of nature-based interventions for people living with mild cognitive impairment or dementia.
Methods: People from the NHS and charities with a diagnosis of mild cognitive impairment or dementia, and their supporters/caregivers (this pair of participants are called a 'dyad') will be approached. The PhD researcher and dyads will meet to discuss the information sheet, answer any questions, then if they'd like to take part, dyads will each complete a consent form and questionnaire asking about demographics, mental health, and service use. A computer will then randomly assign the dyads into the intervention group or waitlist-control group (who will receive the intervention at the end of the study). Supporters/caregivers in the intervention group will attend a one-off online training session on how to use the manual.
The intervention involves 8 weekly sessions of nature-based activities, including a session evaluation sheet to complete for each session. The PhD researcher will call the supporters/caregivers twice during the intervention to check in. At the end of the intervention, dyads will complete another questionnaire each, and then those in the waitlist-control group will have the opportunity to take part in the intervention. There is also an optional interview that dyads can take part in to talk about their experience of the intervention and the study set-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People living with dementia or mild cognitive impairment (PLWD/MCI)
- •Self-reported diagnosis of mild cognitive impairment or dementia (any subtype)
- •18 years old or over
- •Has capacity to consent
- •Willing to follow the sessions in the manual
- •Has a caregiver (family/friend/supporter) that is also willing to take part in the study
- •Currently residing in the community (e.g. own home, supported accommodation)
- •Sufficient command of English to complete questionnaires and to take part in the intervention
- •Supporter/caregiver
- •An unpaid or informal caregiver, who is caring for a person living with a self-reported diagnosis of mild cognitive impairment or dementia (any subtype) i.e. has at least weekly contact together.
- •18 years old or over
- •Has capacity to consent
- •The person that they are supporting/caring for is also willing to take part in the study
- •Willing to deliver the sessions in the manual
- •Willing and able to attend a one-off online caregiver intervention-delivery training session using video conferencing software.
- •Currently residing in the community (e.g. own home, supported accommodation)
- •Sufficient command of English to complete questionnaires and to deliver the intervention
排除标准
- •People living with mild cognitive impairment or dementia
- •Currently residing in a nursing or care home
- •Insufficient command of English to complete questionnaires and to take part in the intervention Supporter/caregiver
- •1. Currently residing in a nursing or care home
- •Insufficient command of English to complete questionnaires and to deliver the intervention
研究组 & 干预措施
Intervention group
Participants will receive the intervention first. Caregivers will attend a one-off training session on how to deliver the intervention. Then the participants will follow the sessions in the intervention manual (8 sessions weekly).
干预措施: Nature-based intervention (Other)
Waitlist-control group
Participants will receive the intervention after the intervention group has finished the intervention. Caregivers will attend a one-off training session on how to deliver the intervention. Then the participants will follow the sessions in the intervention manual (8 sessions weekly).
干预措施: Nature-based intervention (Other)
结局指标
主要结局
Change in wellbeing of the person living with dementia or mild cognitive impairment and their caregiver
时间窗: Post-intervention - 8 weeks after the baseline
As measured by the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - 14-item. Minimum score = 14, maximum score = 70. Higher score means better wellbeing (better outcome).
次要结局
- Costs of providing the intervention(Post-intervention - 8 weeks after the baseline)
- Change in anxiety of the person living with dementia or mild cognitive impairment and their caregiver(Post-intervention - 8 weeks after the baseline)
- Change number of medication used and dosages of the person living with dementia or mild cognitive impairment and their caregiver(Post-intervention - 8 weeks after the baseline)
- Change in connectedness to nature of the person living with dementia or mild cognitive impairment and their caregiver(Post-intervention - 8 weeks after the baseline)
- Change in cognition score of the person living with dementia or mild cognitive impairment(Post-intervention - 8 weeks after the baseline)
- Change in depression of the person living with dementia or mild cognitive impairment and their caregiver(Post-intervention - 8 weeks after the baseline)
- Change in number of services used and types of services used by the person living with dementia or mild cognitive impairment and their caregiver(Post-intervention - 8 weeks after the baseline)
- Change in positive effects of caregiving score of the caregiver from baseline to post-intervention(Post-intervention - 8 weeks after the baseline)
研究者
Harmony Jiang
PhD student
University of Greenwich