Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03554512
Status:
UNKNOWN
Last Update Posted:
2018-06-13
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TelePremie: Telehomecare for Step-down Care Post-NICU Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The State-Trait Anxiety Inventory', 'timeFrame': 'Change from Baseline State-Trait Anxiety at 3 months'}, {'measure': 'The Maternal Confidence Questionnaire', 'timeFrame': 'Change from Baseline self-efficacy at 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal Intensive Care', 'Telehealth', 'Anxiety', 'Self Efficacy', 'Parenting/psychology'], 'conditions': ['Anxiety', 'Self Efficacy']}, 'descriptionModule': {'briefSummary': 'Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). This study will be used to determine whether Telehealth appointments post-NICU discharge can improve the experiences of parents in caring for their infant and reduce the number of health care visits they have with their infant within three months post-NICU discharge.\n\nParticipants in this study will be randomly assigned to two groups. One group will receive the standard of care, which means they will have an appointment in place with a primary care provider, pediatrician or return visit to the NICU post discharge. The second group will have the standard of care described above and two Telehealth visits within the first week at home with their infant.\n\nThe study will explore the experiences of parents of NICU infants following their discharge from NICU, both those receiving standard of care (SOC) and the Telehealth monitoring intervention. Participants will be required to complete surveys online at 5 time periods: when parents decide to be part of the study, prior to discharge from NICU, 1 day after discharge, 2 days following the primary care provider visit and at 3 months following discharge from NICU. The questionnaires used will measure parental anxiety levels and parental confidence. The number of infant visits to the primary care provider, pediatrician, emergency department and NICU will also be collected at three months post-NICU discharge.\n\nA subset of participants (from both SOC and TH groups) will further participate in semi-structured interviews about their experiences in the NICU and caring for their children after discharge. NICU clinicians who consent will participate in semi-structured interviews about their experiences with the Telehealth intervention.\n\nThe cost-effectiveness of the Telehealth intervention will be analysed in comparison to SOC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent-infant pairs admitted to neonatal intensive care unit where study is conducted.\n* Parent has internet access.\n* Parent has literacy level such that they are comfortable reading and filling out surveys.\n* Infant is likely to survive.\n\nExclusion Criteria:\n\n* Infant discharged to foster care.\n* Infant transferred or discharged within 3 days of admission to neonatal intensive care unit.'}, 'identificationModule': {'nctId': 'NCT03554512', 'briefTitle': 'TelePremie: Telehomecare for Step-down Care Post-NICU Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Horizon Health Network'}, 'officialTitle': 'TelePremie: Telehomecare for Step-down Care Post-NICU Discharge', 'orgStudyIdInfo': {'id': 'CHSTHCHHN02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'No Intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Telehealth', 'description': 'Telehealth virtual appointment', 'interventionNames': ['Other: Telehealth virtual appointment']}], 'interventions': [{'name': 'Telehealth virtual appointment', 'type': 'OTHER', 'description': 'Appointment with NICU clinician via telehealth equipment.', 'armGroupLabels': ['Telehealth']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}], 'overallOfficials': [{'name': 'Cecil Ojah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Horizon Health Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horizon Health Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canada Health Infoway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}