Clinical trial NCT06451978: You, Me and Nature Pilot Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Lead sponsor: University of Greenwich
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

People living with mild cognitive impairment or dementia

1. Currently residing in a nursing or care home
2. 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 2. Insufficient command of English to complete questionnaires and to deliver the intervention

Primary outcomes:
measure: Change in wellbeing of the person living with dementia or mild cognitive impairment and their caregiver
timeFrame: Post-intervention - 8 weeks after the baseline
Secondary outcomes:
measure: Change in depression of the person living with dementia or mild cognitive impairment and their caregiver
timeFrame: Post-intervention - 8 weeks after the baseline
measure: Change in anxiety of the person living with dementia or mild cognitive impairment and their caregiver
timeFrame: Post-intervention - 8 weeks after the baseline
measure: Change in connectedness to nature of the person living with dementia or mild cognitive impairment and their caregiver
timeFrame: Post-intervention - 8 weeks after the baseline
measure: Change number of medication used and dosages of the person living with dementia or mild cognitive impairment and their caregiver
timeFrame: Post-intervention - 8 weeks after the baseline
measure: Change in number of services used and types of services used by the person living with dementia or mild cognitive impairment and their caregiver
timeFrame: Post-intervention - 8 weeks after the baseline
measure: Change in cognition score of the person living with dementia or mild cognitive impairment
timeFrame: Post-intervention - 8 weeks after the baseline
measure: Change in positive effects of caregiving score of the caregiver from baseline to post-intervention
timeFrame: Post-intervention - 8 weeks after the baseline
measure: Costs of providing the intervention
timeFrame: Post-intervention - 8 weeks after the baseline
Other outcomes:
Locations:
Study officials:
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