Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-26 @ 9:36 PM
Study NCT ID:
NCT03910192
Status:
UNKNOWN
Last Update Posted:
2019-04-10
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Night time (Sleep) Systolic Blood Pressure', 'timeFrame': '16 weeks', 'description': 'The primary outcome of this study will be change in ANBP from baseline when compared to subsequent follow-up study time points.'}, {'measure': 'Daytime time (Awake) Systolic Blood Pressure', 'timeFrame': '16 Weeks', 'description': 'The primary outcome of this study will be change in daytime ABP from baseline when compared to subsequent follow-up study time points.'}], 'secondaryOutcomes': [{'measure': 'Nocturnal Dipping', 'timeFrame': '16 Weeks', 'description': 'ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values'}, {'measure': 'Atrial Tachyarrhythmia Episodes', 'timeFrame': '16 Weeks', 'description': '24-hour Holter monitoring assessments using the MARS® ambulatory ECG system at baseline and 4 months to assess atrial tachyarrhythmia episodes lasting 30 seconds or more'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '16 Weeks', 'description': '14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations'}, {'measure': 'Profile of Mood States (POMS-SF)', 'timeFrame': '16 Weeks', 'description': '65 item self-report questionnaire examining mood and changes in mood over a period, POMS, in both original and shorter 37 item format, has been extensively used in clinical settings'}, {'measure': 'Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)', 'timeFrame': '16 Weeks', 'description': '24 item the magnitude and changes over time in mindfulness levels, including its five - observing, describing experience, acting with awareness, non-judging of inner experience, and nonreactivity to inner experience facets.'}, {'measure': 'SF-12 v2 Health Survey', 'timeFrame': '16 Weeks', 'description': 'assesses self reported physical and mental health, providing separate scores for 8 sub-domains of physical and mental health (e.g. physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '16 Weeks', 'description': 'The instrument, widely used in epidemiological or clinical contexts, is comprised of seven sub-components (i.e. sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication use, and daytime dysfunction) leading to a global sleep quality score.'}, {'measure': 'Cardiac Anxiety Questionnaire (CAQ)', 'timeFrame': '16 Weeks', 'description': '18 item index of HFA, a measure of anxiety sensitivity specific to cardiovascular patients. The CAQ conceptualizes HFA as a 3 dimensional measure, including heart-related fear, avoidance, attention subscales.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Hypertension', 'Mindfulness', 'Cardiovascular Risk Reduction']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of a 16 week mindfulness-based coaching program compared to a cardiovascular risk reduction education program.\n\nBoth groups will undergo 24-hour ambulatory blood pressure monitoring, along with assessments of psychological measures (see bellow) at study baseline, midpoint (8 weeks), and conclusion (16 weeks).\n\nIn addition, both groups will also undergo 24-hour Holter monitoring assessments at study beginning and conclusion to assess possible episodes of atrial tachyarrhythmia during the assessed interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-80\n* Diagnosed Atrial Fibrillation\n* Night time (Sleep Time) Systolic Blood Pressure≥120 OR Daytime (awake) Systolic Blood Pressure ≥ 135\n* Able and Willing to sign Informed Consent Form\n\nExclusion Criteria:\n\n* Scheduled for Surgery'}, 'identificationModule': {'nctId': 'NCT03910192', 'acronym': 'AF', 'briefTitle': 'Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'York University'}, 'officialTitle': 'Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation', 'orgStudyIdInfo': {'id': '0031-1617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness meditation coaching', 'description': 'Mindfulness-based coaching - participants will receive instructions on (a) mindfulness meditation and gentle mindful movement through home-based and in-class participation at the Southlake Cardiovascular Rehabilitation Clinic and (b) personal coaching support. The health coach will further assist participants through either face-to-face or telephone-based discussions. They will meet with the health coach at mutually-agreed upon on times for designated time periods.', 'interventionNames': ['Behavioral: Mindfulness-based coaching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dietary cardiovascular risk reduction coaching', 'description': 'Cardiovascular risk reduction education - No change to standard of care where participants will receive instructions (in person or by phone call) on how to integrate exercise and dietary changes in your lifestyle to reduce your risk of future cardiovascular events. These instructions will be centered around the DASH dietary practices.', 'interventionNames': ['Behavioral: Dietary cardiovascular risk reduction coaching']}], 'interventions': [{'name': 'Mindfulness-based coaching', 'type': 'BEHAVIORAL', 'description': '16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.', 'armGroupLabels': ['Mindfulness meditation coaching']}, {'name': 'Dietary cardiovascular risk reduction coaching', 'type': 'BEHAVIORAL', 'description': 'Regular in-person meetings, phone calls, or email from study coordinator instructing them on how to integrate exercise and dietary changes in their lifestyle to reduce their risk of future cardiovascular events.', 'armGroupLabels': ['dietary cardiovascular risk reduction coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Ritvo, PhD', 'role': 'CONTACT', 'email': 'pritvo@yorku.ca', 'phone': '4165808021'}, {'name': 'Paul Ritvo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meysam Pirbaglou, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yaariv Khaykin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pouria Alipour, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}], 'centralContacts': [{'name': 'Paul Ritvo, Ph.D', 'role': 'CONTACT', 'email': 'pritvo@yorku.ca', 'phone': '416-736-2100', 'phoneExt': '22396'}], 'overallOfficials': [{'name': 'Paul Ritvo, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'York Univrsity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southlake Regional Health Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Paul Ritvo', 'investigatorAffiliation': 'York University'}}}}