Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613204
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
STELLA-FTD Examination of a Behavior Change Intervention for FTD Family Care Partners
Sponsor:
None
Organization:
None
Study Overview
Official Title:
STELLA-FTD Examination of a Behavior Change Intervention for FTD Family Care Partners
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
STELLA-FTD
Brief Summary:
The purpose of this nationwide study is to test STELLA-FTD Support via Telehealth Living and Learning with Advancing Alzheimers Disease-FTD an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration FTD STELLA-FTD is a multicomponent video-conference based intervention designed to facilitate effective use of community and peer resources to foster effective management of behavioral and psychological symptoms of dementia The study is recruiting families from across the US
Detailed Description:
The study will enroll a total sample of up to 640 participants 320 family care partners and their 320 care Recipients with FTD For our study family Care Partner includes any person who is considered family to the person with FTD such as direct relations fictive kin close friends and neighbors Care Recipient is defined as an individual with an FTD diagnosis noted by the AFTD bv-FTD PPA progressive supranuclear palsy PSP corticobasal degeneration CBD or ALS with FTD Care Recipients with FTD will not participate in intervention but will be consented and thus enrolled because data will collected about them The study will test to see if our program helps Care Partners
The STELLA-FTD intervention is delivered over 8 sessions within 10 consecutive weeks in 1-hour live video-based group sessions led by two guides There will be two intervention groups the control group and the test group There will be up to 8 care Partners per group which allows for the development of mutual trust and commitment
Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation Both groups will receive information and support via videoconferencing The test group will receive a different program than the control group Care Partners will fill out 6 long surveys while in the study and a weekly brief survey
The STELLA-FTD intervention is delivered over 8 sessions within 10 consecutive weeks in 1-hour live video-based group sessions led by two guides There will be two intervention groups the control group and the test group There will be up to 8 care Partners per group which allows for the development of mutual trust and commitment
Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation Both groups will receive information and support via videoconferencing The test group will receive a different program than the control group Care Partners will fill out 6 long surveys while in the study and a weekly brief survey
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