Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT06475534
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Nuestros Días ("Our Days") Study
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
The Mental Health Experiences of Hispanic and Latinx Dementia Caregivers
Status:
RECRUITING
Status Verified Date:
2025-06
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 (i.e., risk factors) or decrease (i.e., 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 participant's preference.
* What daily factors increase (i.e., risk factors) or decrease (i.e., 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 participant's preference.
Detailed Description:
Hispanic and Latino/a/x/e (H\&L) 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 H\&L 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 H\&L 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 H\&L 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 H\&L 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 H\&L caregivers, who are often under-supported and face significant challenges in their caregiving role.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01AG072569 | NIH | None | https://reporter.nih.gov/quic… | View |