Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451978
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-28
Brief Title:
You Me and Nature Pilot Study
Sponsor:
Harmony Jiang
Organization:
University of Greenwich
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 supporterscaregivers 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 supporterscaregivers 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 theyd 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 Supporterscaregivers 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 supporterscaregivers 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
Aim This study is testing a caregiver-led nature-based intervention which has been co-developed with people living with dementia supporterscaregivers 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 supporterscaregivers 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 theyd 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 Supporterscaregivers 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 supporterscaregivers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None