Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-31 @ 11:34 PM
Study NCT ID:
NCT04682535
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2020-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Study of Caregiving Relationships and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva samples from a subsample of n=11 caregivers retained, including 4 samples/day for 5 days per caregiver.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of daily health symptoms', 'timeFrame': '2 weeks', 'description': 'Frequency of adverse health symptoms experienced by participant (e.g., fatigue; 0 to 21)'}, {'measure': 'Perceived sleep quality', 'timeFrame': '2 weeks', 'description': 'Perceived sleep quality the night prior (1 to 5)'}, {'measure': 'Physical activity', 'timeFrame': '2 weeks', 'description': 'Participation in at least 30 minutes of moderate to vigorous physical activity (binary)'}, {'measure': 'Consumption of alcoholic beverages', 'timeFrame': '2 weeks', 'description': 'Consumption of 1 or more alcoholic beverages (binary)'}, {'measure': 'Potential binge eating behaviors', 'timeFrame': '2 weeks', 'description': 'Frequency of binge eating behaviors, including consuming unusually large amount of food, feeling out of control, and unplanned and repetitive eating (0 to 33)'}], 'secondaryOutcomes': [{'measure': 'Total salivary cortisol', 'timeFrame': '2 weeks', 'description': 'Area under the curve score to approximate total cortisol output during the day (μg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver Burnout', 'Dementia', 'Dementia of Alzheimer Type', 'Relations, Family', 'Social Stress', 'Relation, Interpersonal', 'Loneliness']}, 'descriptionModule': {'briefSummary': "The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol.\n\nThis is a pilot study wherein the purpose is to test the feasibility and acceptability of study protocols.", 'detailedDescription': "The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. Investigators are asking caregivers to complete 14-days of surveys which ask about their relationships and health behaviors, in addition to 2 longer surveys (baseline and 3-month follow up). Investigators hypothesize that on days when caregivers receive more emotional support, they will report better health behaviors (e.g., improved sleep quality). On days when caregivers experience greater 1) strain and 2) loneliness, they will report poorer health behaviors. Information about which aspects of social relationships and social connectedness most affect health will be used to inform interventions programs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Spousal family caregivers to persons diagnosed with dementia (any type)', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Spouse or partner to an individual living with ADRD who has received a diagnosis from a physician\n* Aged 18 years or older Provides assistance with at least one instrumental activities of daily living or activities of daily living\n* Not paid to provide care\n* Cares for someone with a global deterioration score of 1 to 5 (early to mid-stage dementia)\n* Has reliable access to email and text messaging, and smart phone device\n* Live within 40 miles of UT Health San Antonio (if completing saliva collection protocol)\n\nExclusion Criteria:\n\n* Inability to read and speak English or Spanish\n* Vision or hearing impairment affecting ability to complete study protocols (e.g., blindness)\n\nAdditional exclusion Criteria if completing saliva collection protocol:\n\n* Experiencing a major health event within the previous 6 months (e.g., stroke, myocardial infarction, in-patient surgery, cancer besides skin cancer)\n* Symptoms of infectious disease within the previous 14-days (e.g., COVID-19, oral infection)\n* Diagnosis of major depressive disorder\n* HPA axis endocrine disorder (e.g., Cushings or Addison's disease)\n* Use of corticosteroid medication\n* Pregnancy\n* Participation in overnight shift work"}, 'identificationModule': {'nctId': 'NCT04682535', 'briefTitle': 'Daily Study of Caregiving Relationships and Health', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Daily Study of Caregiving Relationships and Health', 'orgStudyIdInfo': {'id': 'HSC20200421H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Spousal/partner family caregivers to persons living with dementia. Participants will complete 14-days of surveys about their relationships, social interactions, as well as health and health behaviors. A subsample of n=15 may volunteer to provide diurnal saliva samples.', 'interventionNames': ['Other: Social relationships']}], 'interventions': [{'name': 'Social relationships', 'type': 'OTHER', 'description': 'Exposure to social interactions with spouse, friends, and family. Perceived loneliness, emotional strain, and emotional support.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'timeFrame': 'IPD available following publication of peer-reviewed manuscripts and made available to peer-reviewers upon request', 'ipdSharing': 'YES', 'description': "De-identified IPD used for publication will be available by contacting (i.e., emailing) the PI. Supporting materials available upon request and at PI's discretion."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}