Clinical trial NCT06475534: The Nuestros Días ("Our Days") Study
Official title: The Mental Health Experiences of Hispanic and Latinx Dementia Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Caregiver Burden
Well-Being, Psychological
Stress, Psychological
Depression
Anxiety
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-06-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of older relatives living with memory problems or dementia who are 18 years or older and Identify as Hispanic or Latino/a/x/e,

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Identifies as Hispanic or Latino/a/x/e
3. Provides informal care to a relative living with memory problems or dementia
4. Provides care for 4 hours a day to the person living with memory problems or dementia.

Exclusion Criteria:

1. admission to a nursing home/institutional care for the person living with memory problems or dementia is planned in the next 6 months
2. the potential participant (caregiver) is terminally ill
3. the participant does not have reliable access to the Internet.

Primary outcomes:
measure: Daily Depression Symptom Experience
timeFrame: 63 days
measure: Daily Anxiety Symptom Experience
timeFrame: 63 days
measure: Depression
timeFrame: 12 months
measure: Anxiety
timeFrame: 12 months
measure: Resilience
timeFrame: 12 months
measure: Health Related Quality of Life
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Univeristy of Alabama at Birmingham
name: Frank Puga, PhD
role: PRINCIPAL_INVESTIGATOR
References: