Health Outcomes of Parents With Cystic Fibrosis-Aim 2
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: Parenthood.
- Кому может быть актуально
- Состояния в реестре: Cystic Fibrosis, Parenthood Status. Базовые параметры: от 18 лет · Все.
- 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are: H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression. H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.
Подробное описание
The investigators will follow 146 new parents of children \<5 years of age at 18 participating US adult CF centers to assess the primary outcome of percent predicted forced expiratory volume in one second (ppFEV1) up to 5 years after becoming a parent. A prospective approach will capture the immediate and long-term impact of the use of the highly effective CFTR modulator ETI (elexacaftor/tezacaftor/ivacaftor) by \~90 percent of US adults with CF. By combining objective health measures and participant surveys, the investigators can comprehensively assess the psychosocial impacts of parenthood and explore the interplay between the parenting role and physical and mental health. The investigators anticipate identifying modifiable factors that may ameliorate negative health impacts of parenthood. The investigators will conduct hypothesis-generating, semi-structured dyadic interviews with a subset of parents and their key supports (partner/family/friend) to inform future interventions. The investigators have selected qualitative methodology to avoid preconceived theories/hypotheses.
Вмешательства
- Другое Parenthood
The intervention group will consist of participants who became first time parents to children under 5 years of age.
Первичные конечные точки
- Forced Expiratory Volume (FEV1) [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
Вторичные конечные точки (12)
- Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC) [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1) [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75) [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- History of CF Diagnosis [Срок оценки: Year 1]
- History of CF Genotype Information [Срок оценки: Year 1]
- History of CF Mutation [Срок оценки: Year 1]
- Number of Hospitalizations [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Length of Hospitalizations [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Number of Pulmonary Exacerbations [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Severity of Pulmonary Exacerbations [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Treatment of Pulmonary Exacerbations [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Rate of Hospitalizations Due to Pulmonary Exacerbations [Срок оценки: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
Критерии участия
Критерии включения
- Diagnosed with cystic fibrosis via sweat test or genotype analysis
- Became a first-time parent (including foster parent, step parent, adoptive parent, or legal guardian) to a child under 5 years of age within the last 180 days
Критерии исключения
- Undergone a lung transplant
- Does not speak/read English or Spanish
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 18 центров
- University of Alabama-Birmingham — Birmingham
- National Jewish Health — Denver
- Northwestern University — Evanston
- Indiana University — Indianapolis
- University of Kansas Medical Center — Kansas City
- Johns Hopkins University — Baltimore
- Massachusetts General Hospital — Boston
- Boston Children's Hospital/Brigham and Women's Hospital — Boston
- … и ещё 10 центров
Идентификаторы
NCT: NCT06296394 · STUDY23080161 · 1R01HL161164-01A1 · KAZMER22A0