Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 12:31 PM
Study NCT ID:
NCT03043261
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2017-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject retention', 'timeFrame': '6 month', 'description': 'Percentage of subjects who complete the intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CHF'], 'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility, usability, effectiveness and relevance of an integrated psycho-behavioral intervention on heart failure patients in order to increase support, outreach and general well-being of these patients following hospitalization due to heart failure exacerbation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service because of heart failure\n* NYHA Class ≥ II\n\nExclusion Criteria:\n\n* Significant cognitive impairment, indicated as a mini-mental state exam (MMSE) total score of 23 or lower\n* Lack of convenient internet access outside of hospital\n* Alcohol or other drug dependence/abuse within past 90 days as evaluated by review of medical record and patient interview (SCID)\n* Severe physical disability (visual, sensory or motor) that may interfere with study participation (assessment, online interactive learning)\n* History or presence of psychoses, bipolar disorder, and/or severe personality disorders as evaluated by review of medical record and patient interview (SCID)\n* Life-threatening co-morbidity with the likelihood of 50% mortality in one year\n* Active suicidal ideations\n* Female patients of childbearing potential\n* Treatment with electroconvulsive therapy or transcranial magnetic stimulation within past 90 days\n* Uncorrected hypothyroidism or hyperthyroidism'}, 'identificationModule': {'nctId': 'NCT03043261', 'acronym': 'EMERGE', 'briefTitle': 'Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation', 'orgStudyIdInfo': {'id': 'Pro00078272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psycho-Behavioral Intervention', 'description': 'Williams LifeSkills modules which cover 10 core skills designed to improve coping skills, stress management and interpersonal relationships: 1) being aware of negative thoughts and feelings, 2) making a decision, 3) deflection skills, 4) problem solving or action skills, 5) assertion, 6) saying "no", in addition to the following preventive skills: 7) speaking up, 8) listening, 9) empathy and 10) increasing positives', 'interventionNames': ['Behavioral: Williams LifeSkills']}], 'interventions': [{'name': 'Williams LifeSkills', 'type': 'BEHAVIORAL', 'description': 'Online multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships.', 'armGroupLabels': ['Psycho-Behavioral Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pamela Bonner', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Wei Jiang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}