You, Me and Nature Pilot Study

Harmony Jiang

Status: Active, not recruiting

Conditions: Mild Cognitive Impairment; Dementia

Treatments: Other: Nature-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06451978

VCS-FEHHS-02-22

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

48 participants in 2 patient groups

Intervention group

Experimental group

Description:

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).

Treatment:

Other: Nature-based intervention

Waitlist-control group

Active Comparator group

Description:

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).

Treatment:

Other: Nature-based intervention