The Nuestros Días ("Our Days") Study

NCT06475534 | Recruiting

• 2 other identifiers: IRB-3000087101R01AG072569
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

  63 days

• 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

  63 days

• 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

  12 months

• 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

  12 months

• 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

  12 months

• 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

  12 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Mental Disorders

Study Officials

• Frank Puga, PhD

  Univeristy of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisha Underwood, BS

CONTACT

2059960364; starlab@uab.edu

Loreli Alvarez, MS

CONTACT

2059960339; lalvarez@uab.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 26, 2024
• Study Start: March 27, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)