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Caregiver BurdenNCT06475534

The Nuestros Días ("Our Days") Study

An observational study of Caregiver Burden and Well-Being, Psychological, run by University of Alabama at Birmingham at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
How many people
300 participants
Where
1 siteUnited States
Study dates
27 Mar 2023to 30 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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,

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: The Mental Health Experiences of Hispanic and Latinx Dementia Caregivers

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?
Read more

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.

Read the 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.

Medical subject headings
Caregiver Burden, Psychological Well-Being, Stress, Psychological, Depression, Anxiety Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily Depression Symptom Experience

    Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form, a 4-item scale measuring common symptoms associated with depression.

    Measures common symptoms associated with depression

    4-item Scale 1-5 Likert Scale with 1 indicating "Never" and 5 indicating "Always" Scores range from 4 to 20

    Higher scores indicate higher levels of depressive symptoms

    Measured: 63 days

  2. Daily Anxiety Symptom Experience

    Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form, a 4-item scale measuring common symptoms associated with anxiety.

    Measures common symptoms associated with anxiety

    4-item Scale 1-5 Likert Scale with 1 indicating "Never" and 5 indicating "Always" Scores range from 4 to 20

    Higher scores indicate higher levels of anxiety symptoms

    Measured: 63 days

  3. Depression

    Patient Health Questionnaire-9 (PHQ-9), a 9-item scale for screening, diagnosing, monitoring and measuring the severity of depression.

    9-item Scale 0-3 Likert Scale with 0 indicating "Not at all" and 3 indicating nearly every day" Scores range from 0 to 27

    Scores 0 - 4 = Minimal Depression 5 - 9 = Mild Depression 10 - 14 = Moderate Depression 15 - 19 = Moderate Severe Depression 20 - 27 = Severe Depression

    Measured: 12 months

  4. Anxiety

    General Anxiety Disorder-7 (GAD-7), a 7-item scale for screening, diagnosing, monitoring and measuring the severity of anxiety.

    7-item Scale 0-3 Likert Scale with 0 indicating "Not at all" and 3 indicating nearly every day" Scores range from 0 to 21

    Scores 0 - 4 = Minimal Anxiety 5 - 9 = Mild Anxiety 10 - 14 = Moderate Anxiety >15 = Severe Anxiety

    Measured: 12 months

  5. Resilience

    Resilience Scale for Adults: a 33-item scale measuring personal competence, social competence, personal structure, family coherence, and social support.

    14-item scale with 3 subscales (Perception of self, planned future, structured style) 1-7 Likert Scale with 1 indicating "Not true at all" and 7 indicating "Very true"

    Higher scores indicate higher levels of resilience in the indicated subcategory

    Measured: 12 months

  6. Health Related Quality of Life

    Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health: 10 item scale measuring global health-related quality of life (HRQOL) across 2 domains: physical and mental health.

    10-item Scale 9 Items use 0 to 4 Likert Scale Item 10: 0 to 10 Likert Scale that is recoded to five categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5) Scores range from 0 to 41

    Higher scores indicate better overall mental and physical health

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start27 Mar 2023
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475534
Sponsor's protocol ID
IRB-300008710
Other IDs
1R01AG072569
Status last verified
May 2026
First submitted
12 Jun 2024
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Caregiver Burden and Well-Being, Psychological, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Depression Symptom Experience (time frame: 63 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06475534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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