Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 8:59 PM
Study NCT ID:
NCT02231957
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2014-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2014-08-15', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)', 'timeFrame': '12 weeks after intervention start'}], 'secondaryOutcomes': [{'measure': 'Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)', 'timeFrame': '4 weeks after intervention start'}, {'measure': 'Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)', 'timeFrame': '24 weeks after intervention start'}, {'measure': 'Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination', 'timeFrame': '4 weeks after intervention start'}, {'measure': 'Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination', 'timeFrame': '12 weeks after intervention start'}, {'measure': 'Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination', 'timeFrame': '24 weeks after intervention start'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vaccination']}, 'referencesModule': {'references': [{'pmid': '28736201', 'type': 'DERIVED', 'citation': 'Hofstetter AM, Barrett A, Camargo S, Rosenthal SL, Stockwell MS. Text message reminders for vaccination of adolescents with chronic medical conditions: A randomized clinical trial. Vaccine. 2017 Aug 16;35(35 Pt B):4554-4560. doi: 10.1016/j.vaccine.2017.07.022. Epub 2017 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'There are a growing number of adolescents with chronic medical conditions in the United States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination is also recommended for certain high-risk patients. Limited studies suggest that vaccination coverage of this population remains sub-optimal. Text message vaccine reminder/recall has been shown to be effective in increasing uptake of select pediatric and adolescents vaccines, but has yet to be examined among patients with chronic medical conditions who may also face unique barriers to vaccination. This intervention aims to implement and evaluate the use of text message vaccine reminders among urban low-income minority adolescents with chronic medical conditions. This investigator-initiated study is supported in part by a grant from the Pfizer Medical Education Group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParent with\n\n1. adolescent aged 11-17 years;\n2. adolescent with ≥1 chronic medical condition;\n3. adolescent with clinic visit in last 12 months;\n4. cell phone number listed in hospital registration system\n\nExclusion Criteria:\n\nParent who:\n\n1. does not speak English or Spanish;\n2. is unwilling to receive text message vaccine reminders;\n3. anticipates moving from area in coming 12 months'}, 'identificationModule': {'nctId': 'NCT02231957', 'briefTitle': 'Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions', 'orgStudyIdInfo': {'id': 'AAAM3756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'educational text message reminders', 'description': 'receipt of education-embedded text message vaccine reminders', 'interventionNames': ['Other: educational text message reminders']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional text message reminders', 'description': 'receipt of conventional text message vaccine reminders', 'interventionNames': ['Other: conventional text message reminders']}], 'interventions': [{'name': 'educational text message reminders', 'type': 'OTHER', 'otherNames': ['educational text message vaccine reminders', 'education-embedded text message vaccine reminders'], 'armGroupLabels': ['educational text message reminders']}, {'name': 'conventional text message reminders', 'type': 'OTHER', 'otherNames': ['conventional text message vaccine reminders'], 'armGroupLabels': ['conventional text message reminders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Hospital/Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Annika M Hofstetter, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Annika Hofstetter', 'investigatorAffiliation': 'Columbia University'}}}}