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Идёт набор NCT06397794

Navigating Pregnancy and Parenthood With Lyme Disease

— Наблюдательное Lyme Disease Post Treatment Lyme Disease Chronic Lyme Disease Tick-Borne Infections

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Quantitative surveys and qualitative interview.
Кому может быть актуально
Состояния в реестре: Lyme Disease, Post Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease

Обзор

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.

Подробное описание

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.

Participants 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.

Enrolled 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.

Вмешательства

  • Другое Quantitative surveys and qualitative interview
    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.

Первичные конечные точки

  • Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL [Срок оценки: 3/20/2024 - 3/1/2025]
Вторичные конечные точки (7)
  • Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: 3/20/2024 - 3/1/2025]
  • General Anxiety Disorder-7 (GAD-7) [Срок оценки: 3/20/2024 - 3/1/2025]
  • Parenting Stress Index 4th Edition, Short Form (PSI-4 SF) [Срок оценки: 3/20/2024 - 3/1/2025]
  • 36-Item Short Form Survey (SF-36) [Срок оценки: 3/20/2024 - 3/1/2025]
  • World Health Organization Disability Assessment Schedule (WHODAS 2.0) [Срок оценки: 3/20/2024 - 3/1/2025]
  • Posttraumatic Diagnostic Scale (PDS-5) [Срок оценки: 3/20/2024 - 3/1/2025]
  • Positive Affect and Well-Being Scale [Срок оценки: 3/20/2024 - 3/1/2025]

Критерии участия

Критерии включения

  • Over 18 years of age and reside in the United States or Canada
  • 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

Критерии исключения

  • Under 18 years of age
  • Live outside of the United States or Canada
  • Never been diagnosed with Lyme disease by a medical provider
  • Never been pregnant
  • Never given birth to a liveborn infant
  • Previously participated in a qualitative study about their experience with Lyme disease
  • Do not want to agree to having their interviews audio recorded

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Children's National Hospital — Washington D.C.

Идентификаторы

NCT: NCT06397794 · 00000932

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗