Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT06475534
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Nuestros Días ("Our Days") Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-20', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Depression Symptom Experience', 'timeFrame': '63 days', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form, a 4-item scale measuring common symptoms associated with depression.\n\nMeasures common symptoms associated with depression\n\n4-item Scale 1-5 Likert Scale with 1 indicating "Never" and 5 indicating "Always" Scores range from 4 to 20\n\nHigher scores indicate higher levels of depressive symptoms'}, {'measure': 'Daily Anxiety Symptom Experience', 'timeFrame': '63 days', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form, a 4-item scale measuring common symptoms associated with anxiety.\n\nMeasures common symptoms associated with anxiety\n\n4-item Scale 1-5 Likert Scale with 1 indicating "Never" and 5 indicating "Always" Scores range from 4 to 20\n\nHigher scores indicate higher levels of anxiety symptoms'}, {'measure': 'Depression', 'timeFrame': '12 months', 'description': 'Patient Health Questionnaire-9 (PHQ-9), a 9-item scale for screening, diagnosing, monitoring and measuring the severity of depression.\n\n9-item Scale 0-3 Likert Scale with 0 indicating "Not at all" and 3 indicating nearly every day" Scores range from 0 to 27\n\nScores 0 - 4 = Minimal Depression 5 - 9 = Mild Depression 10 - 14 = Moderate Depression 15 - 19 = Moderate Severe Depression 20 - 27 = Severe Depression'}, {'measure': 'Anxiety', 'timeFrame': '12 months', 'description': 'General Anxiety Disorder-7 (GAD-7), a 7-item scale for screening, diagnosing, monitoring and measuring the severity of anxiety.\n\n7-item Scale 0-3 Likert Scale with 0 indicating "Not at all" and 3 indicating nearly every day" Scores range from 0 to 21\n\nScores 0 - 4 = Minimal Anxiety 5 - 9 = Mild Anxiety 10 - 14 = Moderate Anxiety \\>15 = Severe Anxiety'}, {'measure': 'Resilience', 'timeFrame': '12 months', 'description': 'Resilience Scale for Adults: a 33-item scale measuring personal competence, social competence, personal structure, family coherence, and social support.\n\n14-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"\n\nHigher scores indicate higher levels of resilience in the indicated subcategory'}, {'measure': 'Health Related Quality of Life', 'timeFrame': '12 months', 'description': '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.\n\n10-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\n\nHigher scores indicate better overall mental and physical health'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver Burden', 'Well-Being, Psychological', 'Stress, Psychological', 'Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': "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:\n\n* 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?\n* How do these symptoms vary over time?\n* Do variations in depression and anxiety symptoms predict distal health outcomes?\n\nParticipants will:\n\n* Complete an online baseline survey to understand their caregiving situation.\n* Fill out daily surveys online for three weeks about their caregiving experiences and well-being.\n* Complete two follow-up surveys, along with daily surveys, six and twelve months after the baseline survey.\n\nAll the study information and surveys can be completed in English or Spanish based on the participant's preference.", 'detailedDescription': '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.\n\nAfter 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.\n\nThe study will consist of:\n\n1. Baseline Survey: A 45-minute survey to understand the caregiving situation of each participant.\n2. 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.\n3. 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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,', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or older\n2. Identifies as Hispanic or Latino/a/x/e\n3. Provides informal care to a relative living with memory problems or dementia\n4. Provides care for 4 hours a day to the person living with memory problems or dementia.\n\nExclusion Criteria:\n\n1. admission to a nursing home/institutional care for the person living with memory problems or dementia is planned in the next 6 months\n2. the potential participant (caregiver) is terminally ill\n3. the participant does not have reliable access to the Internet.'}, 'identificationModule': {'nctId': 'NCT06475534', 'briefTitle': 'The Nuestros Días ("Our Days") Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'The Mental Health Experiences of Hispanic and Latinx Dementia Caregivers', 'orgStudyIdInfo': {'id': 'IRB-300008710'}, 'secondaryIdInfos': [{'id': '1R01AG072569', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG072569', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Loreli Alvarez', 'role': 'CONTACT', 'email': 'starlab@uab.edu', 'phone': '205-996-0339'}, {'name': 'Elisha Underwood', 'role': 'CONTACT', 'email': 'starlab@uab.edu', 'phone': '205-996-0364'}, {'name': 'Frank Puga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Elisha Underwood, BS', 'role': 'CONTACT', 'email': 'starlab@uab.edu', 'phone': '2059960364'}, {'name': 'Loreli Alvarez, MS', 'role': 'CONTACT', 'email': 'lalvarez@uab.edu', 'phone': '2059960339'}], 'overallOfficials': [{'name': 'Frank Puga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Frank Puga', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}