Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05274074
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2022-01-27
Brief Title:
Social-Life Enhancing Activities for Caregivers
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Improving Care Partner Outcomes Through Positive Connections
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This study examines a behavioral intervention to improve social connection and reduce loneliness for caregivers of a loved one with Dementia with Lewy Bodies DLB The intervention is called Social LEAF The objective is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB This is an 18-month Stage 2 study examining Social LEAF which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection A pilot phase with 20 caregivers Aim 1 will address these adaptations regarding feasibility acceptability and signal for reducing loneliness with refinements as needed A second phase Aims 2 and 3 will involve a randomized trial comparing Social LEAF to control 30 caregivers in each arm on loneliness primary outcome positive affect mechanism and social engagement mechanism Data will also be collected on acceptability and perceived benefits using mixed methods
Aim 1 is to refine the LEAF intervention to target social relationships and loneliness
Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers
Aim 3 is to examine efficacy of Social LEAF in reducing loneliness increasing positive affect and increasing social engagement
Aim 1 is to refine the LEAF intervention to target social relationships and loneliness
Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers
Aim 3 is to examine efficacy of Social LEAF in reducing loneliness increasing positive affect and increasing social engagement
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG064103 | NIH | None | httpsreporternihgovquickSearchP30AG064103 |