You, Me and Nature Pilot Study

Dementia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451978
• Other study ID #: VCS-FEHHS-02-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: University of Greenwich
• Contact: Harmony Jiang
• Phone: 07712669885
• Email: h.jiang[@]greenwich.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Other:
• Nature-based intervention
The nature-based intervention is a manualised, caregiver-led intervention consisting of a physical manual comprising of 8 sessions of 8 different nature-based activities. It is designed for the person living with dementia or mild cognitive impairment and their caregiver to carry out the sessions together, either in their own home or out in a local area of nature.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harmony Jiang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wellbeing of the person living with dementia or mild cognitive impairment and their caregiver	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).	Post-intervention - 8 weeks after the baseline
Secondary	Change in depression of the person living with dementia or mild cognitive impairment and their caregiver	As measured by the Patient Health Questionnaire-9 (PHQ-9). Minimum score = 0, maximum score = 27. Higher score means higher levels of depression (worse outcome).	Post-intervention - 8 weeks after the baseline
Secondary	Change in anxiety of the person living with dementia or mild cognitive impairment and their caregiver	As measured by the Generalised Anxiety Disorder-7 (GAD-7) Minimum score = 0, maximum score = 21. Higher score means higher levels of anxiety (worse outcome).	Post-intervention - 8 weeks after the baseline
Secondary	Change in connectedness to nature of the person living with dementia or mild cognitive impairment and their caregiver	As measured by the Nature Relatedness Scale - 21-item (NR-21). Minimum score = 21, maximum score = 105. Higher score means higher connectedness to nature (neither better or worse outcome).	Post-intervention - 8 weeks after the baseline
Secondary	Change number of medication used and dosages of the person living with dementia or mild cognitive impairment and their caregiver	As measured using a non-validated questionnaire which was created by the researchers - this is called 'Medication Use'. The non-validated questionnaire asks for the name of the medication, dosage and dose frequency. No minimum or maximum score. Higher use of medication could mean worse outcome.	Post-intervention - 8 weeks after the baseline
Secondary	Change in number of services used and types of services used by the person living with dementia or mild cognitive impairment and their caregiver	As measured using the Client Service Receipt Inventory (CSRI). No minimum or maximum score. Higher use of services could mean better or worse outcome.	Post-intervention - 8 weeks after the baseline
Secondary	Change in cognition score of the person living with dementia or mild cognitive impairment	as measured by the Addenbrooke's Cognitive Examination - ACE-III (UK Version A - 2017).; Minimum score = 0, maximum score = 100. Higher score means higher levels of cognition (better outcome).	Post-intervention - 8 weeks after the baseline
Secondary	Change in positive effects of caregiving score of the caregiver from baseline to post-intervention	As measured by the Gain in Alzheimer care Instrument (GAIN). Minimum score = 0, maximum score = 40. Higher score means higher levels of gains in dementia caregiving (better outcome).	Post-intervention - 8 weeks after the baseline
Secondary	Costs of providing the intervention	As measured using a non-validated questionnaire. No minimum or maximum score. Higher costs could mean worse outcome.	Post-intervention - 8 weeks after the baseline