The Nuestros Días ("Our Days") Study
NCT Number: NCT06475534
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Caregiver Burden|Well-Being, Psychological|Stress, Psychological|Depression|Anxiety
Sponsor: University of Alabama at Birmingham
Collaborators: National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-27
Completion Date: 2027-03-31
Locations: The University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States

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.

Primary Outcome Measures: 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