Health Outcomes of Parents With Cystic Fibrosis-Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 18
- 主要终点
- Forced Expiratory Volume (FEV1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Undergone a lung transplant
- •Does not speak/read English or Spanish
结局指标
主要结局
Forced Expiratory Volume (FEV1)
时间窗: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5
Rate of change in ppFEV1 as reflected in the medical record from Year 1 to Year 5
次要结局
- Length of Hospitalizations(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- History of CF Diagnosis(Year 1)
- Number of Hospitalizations(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Microbiologic Profile(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- BMI(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Parental Stress(Up to 4 times in Year 1, Up to 2 times in Year 2 through Year 5.)
- Life Stressors(Up to 2 times per year in Year 1 through Year 5.)
- Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC)(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1)(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Number of Pulmonary Exacerbations(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Severity of Pulmonary Exacerbations(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Rate of Hospitalizations Due to Pulmonary Exacerbations(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- CF-Related Diabetes Control - Insulin Prescription Usage(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Cystic Fibrosis Questionnaire to evaluate quality of life domains(Up to 2 times per year in Year 1 through Year 5.)
- Parental Responsibility(Up to 4 times in Year 1, Up to 2 times in Year 2 through Year 5.)
- Depression(Up to 4 times in Year 1, Up to 2 times in Year 2 through Year 5.)
- Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75)(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- History of CF Genotype Information(Year 1)
- History of CF Mutation(Year 1)
- Treatment of Pulmonary Exacerbations(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Clinic Visit Attendance(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Medication use(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- History of CF-Related Diabetes Status(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- CF-Related Diabetes Control - Hemoglobin A1C(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- CF-Related Diabetes Control - Glucose Tolerance(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Liver Disease Status(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Transplantation Status(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Sleep Quality(Up to 4 times in Year 1, Up to 2 times in Year 2 through Year 5.)
- Transplantation Type(Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5)
- Social Support(Up to 4 times in Year 1, Up to 2 times in Year 2 through Year 5.)
- Daily Care Check-In(Up to 2 times per year in Year 1 through Year 5.)
- Anxiety(Up to 4 times in Year 1, Up to 2 times in Year 2 through Year 5.)
- Self-Reported Adherence(Up to 2 times per year in Year 1 through Year 5.)
研究者
Traci Kazmerski
Assistant Professor
University of Pittsburgh