Health Outcomes of Parents With Cystic Fibrosis-Aim 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parenthood.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis, Parenthood Status. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other Parenthood
The intervention group will consist of participants who became first time parents to children under 5 years of age.
Primary outcome measures
- Forced Expiratory Volume (FEV1) [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
Secondary outcome measures (12)
- Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC) [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1) [Time frame: 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) [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- History of CF Diagnosis [Time frame: Year 1]
- History of CF Genotype Information [Time frame: Year 1]
- History of CF Mutation [Time frame: Year 1]
- Number of Hospitalizations [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Length of Hospitalizations [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Number of Pulmonary Exacerbations [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Severity of Pulmonary Exacerbations [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Treatment of Pulmonary Exacerbations [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
- Rate of Hospitalizations Due to Pulmonary Exacerbations [Time frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Undergone a lung transplant
- Does not speak/read English or Spanish
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 18 centers
- 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
- … and 10 more centers
Identifiers
NCT: NCT06296394 · STUDY23080161 · 1R01HL161164-01A1 · KAZMER22A0