Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT02010450
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2013-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013398', 'term': 'Sudden Infant Death'}], 'ancestors': [{'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D066088', 'term': 'Infant Death'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dichotomous sleep variable (safe vs unsafe)', 'timeFrame': 'Change from Baseline to 2 Months', 'description': 'change measured using "safe sleep quiz" questionnaire'}], 'secondaryOutcomes': [{'measure': 'determine which incentive item provided is most effective in reinforcing the safe sleep message', 'timeFrame': 'Change from Baseline to 2 Months', 'description': 'determination to be assessed using questionnaire completed by caregiver'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sudden Infant Death Syndrome', 'SIDS', 'safe sleep', 'safe sleep message'], 'conditions': ['Safe Sleep Education']}, 'descriptionModule': {'briefSummary': 'This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent of 1-month old baby\n* Over the age of 18\n* Be able to speak and read English\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02010450', 'briefTitle': 'Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives: Pilot Testing of the MSSC Physician Safe Sleep Taskforce Caregiver Incentive Toolkit', 'orgStudyIdInfo': {'id': '13-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wearable Blanket', 'description': 'subjects randomized to this group will receive a wearable blanket (sleep sack) that contains a safe sleep message.', 'interventionNames': ['Other: Wearable Blanket (Sleep Sack)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'subjects randomized to this group will receive an incentive item (such as a University of Kansas Pediatrics water Bottle) that does not contain the safe sleep message.', 'interventionNames': ['Other: Incentive Item']}], 'interventions': [{'name': 'Wearable Blanket (Sleep Sack)', 'type': 'OTHER', 'armGroupLabels': ['Wearable Blanket']}, {'name': 'Incentive Item', 'type': 'OTHER', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'KU Wichita Pediatrics', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}], 'overallOfficials': [{'name': 'Carolyn R Ahlers-Schmidt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}