Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619327
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Resilient Together for Dementia RT-D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Resilient Together for Dementia A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis
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:
RT-D
Brief Summary:
This study will evaluate the feasibility and preliminary efficacy of the novel Resilient Together for Dementia RT-D intervention for couples following dementia diagnoses The primary target is emotional distress and the program aims to prevent chronic distress in at-risk couples
Detailed Description:
Both persons living with dementia and their spousal care-partners experience high levels of clinically elevated emotional distress which can become chronic without treatment and negatively impact the health quality of life communication and care-planning of both partners A tailored dyadic intervention such as the proposed Resilient Together for Dementia delivered over live video to this at risk population has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones
A pilot feasibility randomized control trial RCT Aim 3 NIA Stage 1B N50 dyads will be conducted of the refined RT-D versus a minimally enhanced educational control MEUC educational pamphlet Primary outcomes will be feasibility credibility and acceptability markers to inform a hybrid efficacy effectiveness R01 year 4 of RT-D vs MEUC NIA Stage II In this subsequent R01 the researcher will examine RT-Ds impact on emotional distress and quality of life outcomes and test mechanisms of change individual and interpersonal resiliency skills through mediation and moderation The researcher will revise the approach if feasibility benchmarks are not met
A pilot feasibility randomized control trial RCT Aim 3 NIA Stage 1B N50 dyads will be conducted of the refined RT-D versus a minimally enhanced educational control MEUC educational pamphlet Primary outcomes will be feasibility credibility and acceptability markers to inform a hybrid efficacy effectiveness R01 year 4 of RT-D vs MEUC NIA Stage II In this subsequent R01 the researcher will examine RT-Ds impact on emotional distress and quality of life outcomes and test mechanisms of change individual and interpersonal resiliency skills through mediation and moderation The researcher will revise the approach if feasibility benchmarks are not met
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