Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-01 @ 3:19 AM
Study NCT ID:
NCT04933812
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarahn.wheeler@duke.edu', 'phone': '919-668-5462', 'title': 'Dr. Sarahn Wheeler', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks after delivery (approximately 1 year)', 'eventGroups': [{'id': 'EG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'IUFD (Intrauterine Fetal Demise)', 'notes': 'Unrelated to study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Sessions Attended by Each Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'description': 'As a measure of effectiveness', 'unitOfMeasure': 'sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Implementation as Measured by the Number of Sessions Including Each Topic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Sessions', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'Individualized Prematurity Prevention Plan', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Changing Baby - Changing You', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'TEAMING UP Together', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Preterm Labor - Warning Signs / Symptoms', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'The Labor Process', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy Progression', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Late Pregnancy Warning Signs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Reunion', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'unitOfMeasure': 'Sessions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sessions', 'denomUnitsSelected': 'Sessions'}, {'type': 'PRIMARY', 'title': 'Engagement as Measured by Number of Participants Who Attended More Than One Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'description': 'Intervention sustainability based on continued engagement from the participants', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Engagement as Measured by Number of Participants Who Completed PSA (Pregnancy-specific Anxiety), IPC-18 (Interpersonal Processes of Care), MSSS (Maternal Social Support Scale), and CSQ-9 (Client Satisfaction Questionnaire) at All Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'description': 'Intervention sustainability based on continued engagement from the participants', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IP3 Knowledge Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'Cervix length and cerclage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Low dose aspirin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Lifestyle modification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at intake', 'description': 'Questionnaire includes approximately four questions aimed to evaluate a participants knowledge about the details of their IP3 plan. Participants will only receive questions that pertain to their specific IP3. They will be given the answers immediately following the assessment. Understanding of preterm birth and precautions; higher scores better, each questionnaire ranges from 0 to 5 questions correct', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received each question per their IP3 plan.'}, {'type': 'SECONDARY', 'title': 'Pregnancy-specific Anxiety (PSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'At intake', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'At Gestational Age 20-28 weeks', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At intake and at gestational age 20-28 weeks', 'description': 'The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. On a Likert scale of 1 to 5, higher scores indicate greater anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Interpersonal Processes of Care (IPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'Lack of clarity', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Elicited concerns, responded', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Explained results', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Decided together', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Emotional support, compassion', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Discriminated due to race/ethnicity', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Disrespectful office staff', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at intake', 'description': 'The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Interpersonal Processes of Care (IPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'Lack of clarity', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Elicited concerns, responded', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Explained results', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Decided together', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Emotional support, compassion', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Discriminated due to race/ethnicity', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Disrespectful office staff', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Gestational age 20-28 weeks', 'description': 'The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Interpersonal Processes of Care (IPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'Lack of clarity', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Elicited concerns, responded', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Explained results', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Decided together', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Emotional support, compassion', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Discriminated due to race/ethnicity', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Disrespectful office staff', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Gestational age >= 30 weeks', 'description': 'The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Social Support Scale (MSSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'At intake', 'categories': [{'measurements': [{'value': '27.3', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Gestational age 20-28 weeks', 'categories': [{'measurements': [{'value': '28.2', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Gestational age >= 30 weeks', 'categories': [{'measurements': [{'value': '27.7', 'spread': '4.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At intake, gestational age 20-28 weeks, and gestational age >=30 weeks', 'description': "The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. On a Likert scale of 1 to 5, higher scores indicate greater social support.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Adherent to the IP3 Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'classes': [{'title': 'IOM weight gain guidelines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Tobacco cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '17-P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cerclage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Serial cervix length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Low dose aspirin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post delivery (up to approximately 40 weeks)', 'description': 'Adherence to the IP3 based on both participant report and EHR chart review; dichotomized as adherent or not adherent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants to which the measure was relevant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.\n\nFacebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-01', 'size': 443935, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-09T14:24', 'hasProtocol': True}, {'date': '2023-01-17', 'size': 502928, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-09T14:24', 'hasProtocol': False}, {'date': '2021-12-17', 'size': 196709, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-03T15:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intervention Arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2021-06-14', 'resultsFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-30', 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)'}, {'measure': 'Number of Sessions Attended by Each Participant', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'description': 'As a measure of effectiveness'}, {'measure': 'Implementation as Measured by the Number of Sessions Including Each Topic', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)'}, {'measure': 'Engagement as Measured by Number of Participants Who Attended More Than One Session', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'description': 'Intervention sustainability based on continued engagement from the participants'}, {'measure': 'Engagement as Measured by Number of Participants Who Completed PSA (Pregnancy-specific Anxiety), IPC-18 (Interpersonal Processes of Care), MSSS (Maternal Social Support Scale), and CSQ-9 (Client Satisfaction Questionnaire) at All Time Points', 'timeFrame': 'up to 12 weeks after delivery (approximately 1 year)', 'description': 'Intervention sustainability based on continued engagement from the participants'}], 'secondaryOutcomes': [{'measure': 'IP3 Knowledge Questionnaire', 'timeFrame': 'at intake', 'description': 'Questionnaire includes approximately four questions aimed to evaluate a participants knowledge about the details of their IP3 plan. Participants will only receive questions that pertain to their specific IP3. They will be given the answers immediately following the assessment. Understanding of preterm birth and precautions; higher scores better, each questionnaire ranges from 0 to 5 questions correct'}, {'measure': 'Pregnancy-specific Anxiety (PSA)', 'timeFrame': 'At intake and at gestational age 20-28 weeks', 'description': 'The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. On a Likert scale of 1 to 5, higher scores indicate greater anxiety.'}, {'measure': 'Interpersonal Processes of Care (IPC)', 'timeFrame': 'at intake', 'description': 'The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.'}, {'measure': 'Interpersonal Processes of Care (IPC)', 'timeFrame': 'Gestational age 20-28 weeks', 'description': 'The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.'}, {'measure': 'Interpersonal Processes of Care (IPC)', 'timeFrame': 'Gestational age >= 30 weeks', 'description': 'The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.'}, {'measure': 'Maternal Social Support Scale (MSSS)', 'timeFrame': 'At intake, gestational age 20-28 weeks, and gestational age >=30 weeks', 'description': "The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. On a Likert scale of 1 to 5, higher scores indicate greater social support."}, {'measure': 'Number of Participants Who Were Adherent to the IP3 Plan', 'timeFrame': 'Post delivery (up to approximately 40 weeks)', 'description': 'Adherence to the IP3 based on both participant report and EHR chart review; dichotomized as adherent or not adherent.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '36636112', 'type': 'DERIVED', 'citation': 'Wheeler SM, Massengale KEC, Fitzgerald TA, Truong T, Ostbye T, Corneli A, Swamy GK. IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk. Health Equity. 2022 Dec 19;6(1):922-932. doi: 10.1089/heq.2022.0089. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger trial focused on determining efficacy. Feasibility will be measured using the RE-AIM framework4: Reach or Participation (Primary Outcome): (a) percent of eligible participants who are successfully recruited and attend at least one group session; Effectiveness: retention rate in the intervention; Implementation: fidelity to the intervention protocol; Maintenance: intervention sustainability based on continued engagement from the participants.', 'detailedDescription': 'Non-Hispanic black (NHB) women are 49% more likely to experience a preterm birth (PTB), delivery before 37 weeks. PTB is associated with increased risk of poor short and long-term neonatal outcomes. PTB can occur in multiple clinical scenarios including spontaneous PTB (e.g. preterm labor, preterm pre-labor rupture of membranes) and medically induced preterm labor (e.g. preeclampsia). Women with a history of PTB are at 1.5 - 2 fold increased risk for future PTB. There are medical therapies than can reduce the risk of recurrent PTB specific to the presumed etiology of the prior PTB. Thus, women with a history of a prior PTB who receive care with Duke Maternal Fetal Medicine (MFM) receive and Individualized Prematurity Prevention Plan (IP3) to reduce their risk of recurrent PTB. The IP3 plans are often labor intensive with requirements ranging from daily medications, weekly clinic visits, painful injections or invasive ultrasounds.\n\nGiven the increased rate so of PTB among NHB women and some suggestion of decreased adherence in this population1, we previously conducted qualitative studies with NHB women to uncover patient perceived barriers to IP3 adherence2,3. These studies revealed that NHB women with prior preterm birth felt that stress and lack of support were key barriers to preterm birth prevention adherence. Stress and limited support made women feel isolated from their peers and community. Based on these data we worked with a stakeholder group to develop a patient-centered, community-involved intervention that will increased adherence to an individualized prematurity prevention plan using community-level social supports. The resulting invention titled, EngagINg the COmmunity to Reduce Preterm Birth via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3) includes community doula led group social support.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self describe race as Non-hispanic black\n* history of prior singleton preterm delivery (before 37 weeks gestation\n* current singleton gestation, with Individualized Prematurity Prevention (IP3) plan.\n\nExclusion Criteria:\n\n* women with anomalous fetuses\n* age below 18 years\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT04933812', 'briefTitle': 'EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3)', 'orgStudyIdInfo': {'id': 'Pro00107668'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group Social Support Meetings and Facebook Group', 'description': 'Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.', 'interventionNames': ['Behavioral: Facebook discussions and Virtual group meetings']}], 'interventions': [{'name': 'Facebook discussions and Virtual group meetings', 'type': 'BEHAVIORAL', 'description': 'Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom', 'armGroupLabels': ['Group Social Support Meetings and Facebook Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sarahn Wheeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}