Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475534
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-12
Brief Title:
The Nuestros Días Our Days Study
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
The Mental Health Experiences of Hispanic and Latinx Dementia Caregivers
Status:
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:
The goal of this observational study is to understand how contextual individual-level and cultural factors influence the daily and long-term well-being of caregivers of relatives with memory problems or dementia The study focuses on caregivers from the Hispanic and Latino community The main questions it aims to answer are
What daily factors increase ie risk factors or decrease ie protective factors the daily odds of depression and anxiety symptoms reported by caregivers
How do these symptoms vary over time
Do variations in depression and anxiety symptoms predict distal health outcomes
Participants will
Complete an online baseline survey to understand their caregiving situation
Fill out daily surveys online for three weeks about their caregiving experiences and well-being
Complete two follow-up surveys along with daily surveys six and twelve months after the baseline survey
All the study information and surveys can be completed in English or Spanish based on the participants preference
What daily factors increase ie risk factors or decrease ie protective factors the daily odds of depression and anxiety symptoms reported by caregivers
How do these symptoms vary over time
Do variations in depression and anxiety symptoms predict distal health outcomes
Participants will
Complete an online baseline survey to understand their caregiving situation
Fill out daily surveys online for three weeks about their caregiving experiences and well-being
Complete two follow-up surveys along with daily surveys six and twelve months after the baseline survey
All the study information and surveys can be completed in English or Spanish based on the participants preference
Detailed Description:
Hispanic and Latinoaxe HL family caregivers of older relatives living with memory problems or dementia often experience poor mental health due to the increased stress associated with caregiving The purpose of this study is to examine how contextual individual-level and cultural factors influence daily and long-term patterns of depression and anxiety symptoms among HL caregivers The investigators will collect data at multiple time points to understand their daily experiences and possible relationships among these factors
After initial contact potential participants will complete two eligibility surveys to determine if they are a good fit for the study If eligible they will receive a study information sheet outlining all procedures risks and benefits
The study will consist of
1 Baseline Survey A 45-minute survey to understand the caregiving situation of each participant
2 Daily Diaries After completing the baseline survey participants will fill out daily surveys for 21 days These 10-minute surveys will ask about their thoughts feelings and experiences of the day and will be emailed at 7 pm each night
3 Follow-Up Phases Participants will complete two follow-up phases one at six months and one at twelve months after the baseline survey Each phase includes an extended follow-up survey and another series of 21 daily diaries
The results from this study will inform a dynamic framework of HL caregiver mental health by identifying modifiable intervention targets associated with resilience over time This study represents a critical step forward in developing effective culturally sensitive interventions to support the health and well-being of HL caregivers who are often under-supported and face significant challenges in their caregiving role
After initial contact potential participants will complete two eligibility surveys to determine if they are a good fit for the study If eligible they will receive a study information sheet outlining all procedures risks and benefits
The study will consist of
1 Baseline Survey A 45-minute survey to understand the caregiving situation of each participant
2 Daily Diaries After completing the baseline survey participants will fill out daily surveys for 21 days These 10-minute surveys will ask about their thoughts feelings and experiences of the day and will be emailed at 7 pm each night
3 Follow-Up Phases Participants will complete two follow-up phases one at six months and one at twelve months after the baseline survey Each phase includes an extended follow-up survey and another series of 21 daily diaries
The results from this study will inform a dynamic framework of HL caregiver mental health by identifying modifiable intervention targets associated with resilience over time This study represents a critical step forward in developing effective culturally sensitive interventions to support the health and well-being of HL caregivers who are often under-supported and face significant challenges in their caregiving role
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 |
|---|---|---|---|
| 1R01AG072569 | NIH | None | None |