The Nuestros Días ("Our Days") Study

NCT ID: NCT06475534

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2027-03-31

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.

Conditions

Caregiver Burden; Well-Being, Psychological; Stress, Psychological; Depression; Anxiety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Frank Puga

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Puga, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Alabama at Birmingham

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elisha Underwood, BS

Role: CONTACT

starlab@uab.edu

2059960364

Loreli Alvarez, MS

Role: CONTACT

lalvarez@uab.edu

2059960339

Facility Contacts

Loreli Alvarez

Role: primary

starlab@uab.edu

205-996-0339

Elisha Underwood

Role: backup

starlab@uab.edu

205-996-0364

Other Identifiers

1R01AG072569

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300008710

Identifier Type: -

Identifier Source: org_study_id