Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT05383027
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2022-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale-10', 'timeFrame': '13 weeks', 'description': 'Measure of stress'}, {'measure': 'Zarit Burden Interview', 'timeFrame': '13 weeks', 'description': 'Measures participant burden'}, {'measure': 'Brief Resilience Scale', 'timeFrame': '13 weeks', 'description': 'Measures participant resillience'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease and Related Dementias Family Caregivers"]}, 'descriptionModule': {'briefSummary': "In a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (HRVB) intervention vs music listening control (MLC) for 30 family caregivers 18 years and older (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and above\n* primary, unpaid family caregiver for ADRD patient for 6 months or more\n* owns and operates a smartphone with a data plan\n* greater than of equal to 4 on caregiver burden scale\n\nExclusion Criteria:\n\n* regular mind-body practice\n* under 18 years old\n* pacemaker\n* conditions or medications that interfere with heart rate variability'}, 'identificationModule': {'nctId': 'NCT05383027', 'acronym': 'CARES', 'briefTitle': "Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study", 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': "Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study(CARES)", 'orgStudyIdInfo': {'id': '000141913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Music Listening Control(MLC)', 'interventionNames': ['Behavioral: Music Listening Control (MLC)']}, {'type': 'EXPERIMENTAL', 'label': 'Heart Focused Breathing', 'interventionNames': ['Behavioral: Heart Focused Breathing']}], 'interventions': [{'name': 'Music Listening Control (MLC)', 'type': 'BEHAVIORAL', 'description': 'MLC participants will engage in assigned music listening in the presence of their loved one with ADRD via a selected online platform (pandora or Spotify) for 10 minutes a day 5-7 days a week.', 'armGroupLabels': ['Music Listening Control(MLC)']}, {'name': 'Heart Focused Breathing', 'type': 'BEHAVIORAL', 'description': 'Heart-focused breathing participants will engage in heart-focused breathing using the inner balance device (shipped to their home), they will be asked to do this in the presence of their loved one with ADRD for 10 minutes a day 5-7 days per week.', 'armGroupLabels': ['Heart Focused Breathing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Linda K Larkey, PhD', 'role': 'CONTACT', 'email': 'linda.larkey@asu.edu', 'phone': '602-821-2366'}], 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'centralContacts': [{'name': 'Linda K Larkey, PhD', 'role': 'CONTACT', 'email': 'linda.larkey@asu.edu', 'phone': '6028212366'}, {'name': 'Dara James, PhD', 'role': 'CONTACT', 'email': 'dara.james@asu.edu', 'phone': '2074791440'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}