Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT06397794
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigating Pregnancy and Parenthood With Lyme Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D000077342', 'term': 'Post-Lyme Disease Syndrome'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': "Semi-structured qualitative interviews will be conducted with parents with LD, PTLDS, and/or CL to understand their lived experience. The interviewer will follow a structured interview guide about participants' Lyme disease history, pregnancy, parenting experience, relationships, and their priorities. The interviewer will ask open-ended questions to understand participants' context and allow participants to share what they feel is important to them."}], 'secondaryOutcomes': [{'measure': 'Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': 'Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) prior to their qualitative interviews. The EPDS is a 10-question standardized postnatal depression screener.'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': 'Participants will complete the General Anxiety Disorder-7 (GAD-7) screener prior to their qualitative interviews. The GAD-7 is a 7-question standardized assessment that measures severity of anxiety symptoms.'}, {'measure': 'Parenting Stress Index 4th Edition, Short Form (PSI-4 SF)', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': 'Participants will complete the Parenting Stress Index 4th Edition, Short Form (PSI-4 SF) prior to their qualitative interviews. The PSI-4 SF is a standardized assessment that measures child and parent characteristics and stress experienced by a parent.'}, {'measure': '36-Item Short Form Survey (SF-36)', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': 'Participants will complete the36-Item Short Form Survey (SF-36) prior to their qualitative interviews. The SF-36 is a standardized quality of life assessment.'}, {'measure': 'World Health Organization Disability Assessment Schedule (WHODAS 2.0)', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': 'Participants will complete the WHO Disability Assessment Schedule (WHODAS 2.0) prior to their qualitative interviews. The WHODAS 2.0 is a 36-question standardized measure of health and disability.'}, {'measure': 'Posttraumatic Diagnostic Scale (PDS-5)', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': 'Participants will complete a modified version of the Posttraumatic Diagnostic Scale (PDS-5) prior to their qualitative interviews. The PDS-5 is a 24-question standardized measure of posttraumatic stress symptomatology. Participants will answer questions specific to their experience with Lyme disease.'}, {'measure': 'Positive Affect and Well-Being Scale', 'timeFrame': '3/20/2024 - 3/1/2025', 'description': "Participants will complete the Positive Affect and Well-Being Scale prior to their qualitative interviews. The Positive Affect and Well-Being Scale is a 9-item measure of participants' sense of well-being."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lyme Disease', 'Post Treatment Lyme Disease', 'Chronic Lyme Disease', 'Tick-Borne Infections', 'Tick-Borne Diseases', 'Pregnancy Complications', 'Parenting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cri-datacap.org/surveys/?s=Y443RE43E43XN9D8', 'label': 'Participant enrollment screener'}]}, 'descriptionModule': {'briefSummary': "This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.", 'detailedDescription': "Patients with chronic conditions may experience the perinatal period and the experience of parenting differently than their healthy peers. The purpose of this study is to understand the lived experiences of pregnancy and parenting among gestational parents with Lyme disease.\n\nParticipants may be included in this study if they report having received a diagnosis of Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), or chronic Lyme (CL) and they have given birth to at least one liveborn child. The investigators hypothesize that patients with LD/PTLDS/CL will experience unique challenges related to pregnancy, experiences in medical care settings, and their child's development.\n\nEnrolled participants will complete a brief set of online quantitative questionnaires on topics such as their demographic characteristics, family information, Lyme disease histories, and mental health. The investigators will report on these data to illustrate similarities and differences between participants in the study for potentially relevant factors (e.g., timing of Lyme diagnosis relative to pregnancy, symptoms, mental health concerns). The questionnaires will be followed by an in-depth qualitative interview in English with each participant to learn about their experiences related to pregnancy and parenting with LD/PTLDS/CL, including specific questions about navigating the health care system, information seeking behaviors, and their child's development."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will enroll up to 30 participants in this study, all of whom have been pregnant in the past and given birth to at least one liveborn child. There is no limit to the number of children a participant has, age of child(ren), or duration of Lyme-related symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age and reside in the United States or Canada\n* Diagnosed with acute Lyme disease, PTLDS, and/or Chronic Lyme by a health care provider while they were pregnant OR PTLDS/CL prior to becoming pregnant with ongoing symptoms during pregnancy\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Live outside of the United States or Canada\n* Never been diagnosed with Lyme disease by a medical provider\n* Never been pregnant\n* Never given birth to a liveborn infant\n* Previously participated in a qualitative study about their experience with Lyme disease\n* Do not want to agree to having their interviews audio recorded'}, 'identificationModule': {'nctId': 'NCT06397794', 'briefTitle': 'Navigating Pregnancy and Parenthood With Lyme Disease', 'organization': {'class': 'OTHER', 'fullName': "Children's National Research Institute"}, 'officialTitle': 'Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease', 'orgStudyIdInfo': {'id': '00000932'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gestational parents with Lyme disease', 'description': 'Participants in this study will be enrolled following a screening call to assess their eligibility. All participants must report that they were diagnosed with acute Lyme disease, PTLDS, and/or Chronic Lyme by a health care provider while they were pregnant OR PTLDS/CL prior to becoming pregnant with ongoing symptoms during pregnancy.\n\nAfter being consented for the study, participants will then complete a set of online questionnaires and participate in a qualitative interview with a member of the research team.', 'interventionNames': ['Other: Quantitative surveys and qualitative interview']}], 'interventions': [{'name': 'Quantitative surveys and qualitative interview', 'type': 'OTHER', 'description': 'All participants will complete online surveys on topics including demographic and socioeconomic information, medical history (parent and child), pregnancy history, and mental health and well-being. They will then participate in a qualitative interview about their pregnancy and parenting experiences as gestational parents with Lyme disease.', 'armGroupLabels': ['Gestational parents with Lyme disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meagan Williams, MSPH, CCRC', 'role': 'CONTACT', 'email': 'mewilliams@childrensnational.org', 'phone': '202-476-3388'}, {'name': 'Sarah B. Mulkey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roberta L. DeBiasi, MD, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Meagan E Williams, MSPH, CCRC', 'role': 'CONTACT', 'email': 'mewilliams@childrensnational.org', 'phone': '202-476-3388'}, {'name': 'Sarah B. Mulkey, MD, PhD', 'role': 'CONTACT', 'email': 'sbmulkey@childrensnational.org'}], 'overallOfficials': [{'name': 'Sarah B. Mulkey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's National Research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's National Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Trials Network for Lyme and Other Tick-Borne Diseases', 'class': 'UNKNOWN'}, {'name': 'Steven & Alexandra Cohen Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}