Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568107
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Person-Centered Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
Brief Summary:
The purpose of this study is to test a person-centered nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations The Environmental And Sensory Experience EASE involves the projection of a still nature image and the playing of nature sounds Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the residents behalf The survey informs the research team on what nature scene to show Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns
Detailed Description:
After enrolling in the study participants will participate in three study visits During the first two visits study personnel will observe the nursing home resident to collect data on the residents vocalizing behaviors persistent vocalizations PVs These visits will last for roughly six hours one during the day shift and one during the evening shift The third visit will last approximately 90 minutes During this visit study personnel will observe vocalizing behaviors before during and after the EASE intervention is in use Residents will also wear a watch for all three visits that records information about their heart rate and stress levels All visits will occur in the residents natural environment- either their room or common space and will be scheduled at the convenience of the resident and NH staff
The aims of the study are
Aim 1 Examine the feasibility and preliminary efficacy of the EASE to reduce PVs among NH residents
Aim 2 Evaluate the NH staff perception of the acceptability of the EASE within 48 hours post-intervention
Aim 3 Examine the mechanism of action of the EASE
The aims of the study are
Aim 1 Examine the feasibility and preliminary efficacy of the EASE to reduce PVs among NH residents
Aim 2 Evaluate the NH staff perception of the acceptability of the EASE within 48 hours post-intervention
Aim 3 Examine the mechanism of action of the EASE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None