Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-17 @ 4:08 AM
Study NCT ID:
NCT02819895
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRIMM Trial (Phone Reminder for IMMunization)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunization Rates at 14 weeks', 'timeFrame': '14 Weeks', 'description': 'To determine if an automated customized telephone and email immunization reminder system can increase the 14-week immunization rates, by at least 10% among those who receive immunization reminders versus those who do not.'}], 'secondaryOutcomes': [{'measure': 'Immunization Rates at 14 Months', 'timeFrame': '14 Months', 'description': 'To determine the effect of an automated customized phone and email immunization reminder system on the proportion of children completely immunized at 14 months among those who receive immunization reminders versus those who do not.'}, {'measure': 'Timeliness of Immunization Receipt', 'timeFrame': '14 Months', 'description': 'To determine if the proportion of infants who receive their immunizations within 1-week of its due date is higher in infants of parents who receive phone and email immunization reminders versus those who do not.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phone Appointment Reminder', 'Immunization Rates', 'mHealth'], 'conditions': ['Immunization']}, 'referencesModule': {'references': [{'pmid': '31139442', 'type': 'DERIVED', 'citation': 'Ekhaguere OA, Oluwafemi RO, Badejoko B, Oyeneyin LO, Butali A, Lowenthal ED, Steenhoff AP. Automated phone call and text reminders for childhood immunisations (PRIMM): a randomised controlled trial in Nigeria. BMJ Glob Health. 2019 Apr 3;4(2):e001232. doi: 10.1136/bmjgh-2018-001232. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a customized automated telephone and email immunization reminder system will be feasible, acceptable, and significantly improve immunization utilization rates.', 'detailedDescription': 'Background: Worldwide, vaccine preventable diseases account for 29% of all deaths between 1 month and 5 years, underscoring the importance of immunizations. In Nigeria, routine childhood immunization rates are unacceptably inconsistent and low, ranging from 35-85% at 14 weeks and 10-37% for all routine immunizations at 12-24 months.\n\nGAP: The feasibility, acceptability and utility of an automated phone immunization reminder system have never been explored in this rural setting of Nigeria.\n\nHYPOTHESIS: Given \\~90% of the adult population in Nigeria uses a mobile phone, a customized mHealth immunization reminder system will be feasible and acceptable; and will significantly improve immunization rates in this rural setting of Ondo State, Nigeria.\n\nMETHODS: A prospective randomized controlled trial study design will be utilized. This study will recruit parents of healthy newborn infants delivered at Mother and Child Hospital Ondo, who live in Akure or Ondo Town and plan to receive their immunizations at Mother and Child Hospital Ondo.\n\nDATA ANALYSIS: The proportion of immunization visits between intervention and control groups will be compared using a two-sided, two sample test of proportions with p \\<0.05 being significant. Secondary analysis will focus on the predictive value of social demographic variables on immunization rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Week', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parents of healthy infants who have a cellular phone\n2. Born at Mother and Child Hospital Ondo (Akure or Ondo Town)\n3. Plans to receive immunizations at Mother and Child Hospital Ondo\n\nExclusion Criteria:\n\n1. Parents of infants requiring hospital admission due to illness or prematurity.\n2. Parents without a cellular phone'}, 'identificationModule': {'nctId': 'NCT02819895', 'briefTitle': 'PRIMM Trial (Phone Reminder for IMMunization)', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria', 'orgStudyIdInfo': {'id': '15-012572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Parents of healthy newborn infants delivered at Mother and Child Hospital Ondo (Akure or Ondo), who live in Akure or Ondo Town and plan to receive their immunizations at MCH Ondo will receive their usual care (an immunization card). In addition they will received automated text, calls and emails (if applicable) reminders through a customized windows® software application when their child's immunization visit is due.", 'interventionNames': ['Other: A customized windows® software application']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Parents of healthy newborn infants delivered at Mother and Child Hospital Ondo (Akure or Ondo), who live in Akure or Ondo Town and plan to receive their immunizations at MCH Ondo will receive usual care (an immunization card)'}], 'interventions': [{'name': 'A customized windows® software application', 'type': 'OTHER', 'description': 'A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Akure', 'state': 'Ondo State', 'country': 'Nigeria', 'facility': 'Mother and Child Hospital Ondo', 'geoPoint': {'lat': 7.25256, 'lon': 5.19312}}, {'zip': '11111', 'city': 'Ondo', 'country': 'Nigeria', 'facility': 'Mother and Child Hospital Ondo', 'geoPoint': {'lat': 7.09316, 'lon': 4.83528}}], 'overallOfficials': [{'name': 'Osayame Ekhaguere, MBBS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Andrew Steenhoff, MBBCh', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Elizbeth Lowenthal, MD, MSCE', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}