Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT05094518
Status:
UNKNOWN
Last Update Posted:
2021-10-26
First Post:
2021-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-21', 'size': 391484, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-21T14:39', 'hasProtocol': True}, {'date': '2021-10-21', 'size': 118047, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-10-21T14:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention group cluster will use the HERA application to receive appointment reminders. The Informed and Non-Informed Control groups will not be using the HERA application.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of attendance for prenatal care visits', 'timeFrame': '6 months', 'description': 'The number of 4 mandatory prenatal care appointments that are attended are presented here.'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic and Health information form data', 'timeFrame': '6 months', 'description': 'Data about sociodemographic and health information of participants will be presented here.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile health', 'Refugee'], 'conditions': ['Prenatal Care', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of mobile phone based appointment reminder notifications sent through Health Recording App (HERA) in increasing the uptake of 4 World Health Organization recommended prenatal visits among Syrian refugee population.', 'detailedDescription': 'Background: 12 million Syrians have been forcibly displaced from their homes since the start of Syrian Civil War in 2011. Despite Turkey providing free healthcare services through national insurance to nearly 4 million refugees that it hosts, pregnant Syrian women are less likely to attend prenatal visits and more likely to die during and after labor. An increase in the uptake of prenatal care may improve quality of life through healthy pregnancies and safer labor conditions in this population with double vulnerability.\n\nMobile phone-based reminders have been shown in randomized controlled trials and systematic reviews to increase the uptake of various services, including prenatal care. Mobile phone penetration is high among Syrian refugees in Turkey and qualitative studies demonstrate that mobile health interventions are acceptable and feasible for Syrian refugees.\n\nPrimary objective: To evaluate the impact of mobile phone-based reminders on the uptake of prenatal care among pregnant Syrian refugee women. More specifically, the study assesses the effectiveness of mobile phone-based reminders by measuring the percent increase in the number of prenatal appointments attended by intervention arm participants compared to the control arm participants.\n\nStudy design: This is a behavioral intervention study using an un-blinded, parallel groups, randomized controlled study design.\n\nPrimary Outcome:\n\nThe primary outcome of this study is the number of medical visits, following the initial baseline prenatal care visit, over the 6 month period prior to childbirth.\n\nSecondary outcomes:\n\nSecondary outcomes are based on the Sociodemographic and Health History form. The form gathers information about demographics of the participants (age, education, employment, marital status, number of children) and health history (previous pregnancies, delivery methods, miscarriages, stillborn, chronic conditions and medications. We will further examine these risk factors on the number of medical visits during the study period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having the status of "Syrian under temporary protection"\n* Being in the first trimester of the pregnancy\n* Initial prenatal visit\n* Age equal or greater than 18 years and less than or equal to 49\n\nExclusion Criteria:\n\n* Having a citizenship or a status other than "Syrian under temporary protection"\n* Not owning a mobile phone\n* Being unable to read and write\n* Not initial prenatal visit\n* Having a chronic disorder or high-risk pregnancy that requires the individual to go to the hospital frequently. Frequently is defined as more than 3 visits post the baseline visit.\n* While gestating, those that develop a high-risk pregnancy that requires more than 3 visits post the baseline visit.'}, 'identificationModule': {'nctId': 'NCT05094518', 'briefTitle': 'A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey', 'organization': {'class': 'OTHER', 'fullName': 'HERA Inc'}, 'officialTitle': 'A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey', 'orgStudyIdInfo': {'id': 'HeraInc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reminder', 'description': 'Participants will fill the sociodemographic and health history form. Participants will receive reminders in the form of push notifications for prenatal checkup dates automatically generated according to their pregnancy start data or initial check-up appointment for 6 months. Reminders will be sent at the following intervals: 1) 2 weeks before the appointment, 2) 1 day before the appointment, and 3) on the day of appointment. After this date, participants will receive push notifications asking whether they went to the appointment or not weekly for 1 month. This reminder algorithm will be used for each prenatal checkup for a total of four appointments: once in first trimester, once in second trimester and two in third trimester, using the World Health Organization and Turkish Ministry of Health prenatal checkup calendar. At the end of 6 months of follow up period, participants will be contacted via phone call to ask for any remaining appointments or unanswered notifications.', 'interventionNames': ['Behavioral: Mobile phone reminders']}, {'type': 'NO_INTERVENTION', 'label': 'Informed Control No Reminder', 'description': 'Participants will fill the sociodemographic and health history form. Their contact information will be gathered. Participants will be contacted at the end of 6 months and will be asked about the number of the prenatal care appointments they have attended during their pregnancy.'}, {'type': 'NO_INTERVENTION', 'label': 'Uninformed Control No Reminder', 'description': 'Participants will fill the sociodemographic and health history form. No contact information will be gathered. The purpose of this arm is to estimate the "true" baseline for the number of visits without any extra attention given by the medical staff.'}], 'interventions': [{'name': 'Mobile phone reminders', 'type': 'BEHAVIORAL', 'description': 'Appointment reminders in the form of push notifications will be sent through HERA app.', 'armGroupLabels': ['Reminder']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aral Surmeli, MD', 'role': 'CONTACT', 'email': 'a.surmeli@medak.org.tr', 'phone': '+905353140179'}], 'overallOfficials': [{'name': 'Aral Surmeli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Founder/CEO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HERA Inc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Rescue Association (MEDAK), Turkey', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}