Impact of Parenthood on Health in People with Cystic Fibrosis
Health Outcomes of Parents With Cystic Fibrosis-Aim 2
This study looks at how becoming a parent affects the health of people with cystic fibrosis, especially their lung function and mental well-being, over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 18 sites (Birmingham, Alabama and 17 other locations) |
| Trial ID | NCT06296394 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the health effects of parenthood on individuals with cystic fibrosis (CF) in the context of modern CFTR modulator therapies. It will follow 146 new parents of children under 5 years old across 18 CF centers in the US, assessing both physical and mental health outcomes over a period of up to 5 years. The study will investigate how factors such as depression and parental responsibilities influence lung function, measured by percent predicted forced expiratory volume in one second (ppFEV1). Additionally, qualitative interviews will be conducted to gather insights on the psychosocial impacts of parenthood and identify potential areas for intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with cystic fibrosis who have recently become first-time parents to a child under 5 years of age.
Not a fit: Patients who have undergone a lung transplant or do not speak/read English or Spanish may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how parenthood affects the health of individuals with cystic fibrosis, potentially leading to targeted interventions that improve their quality of life.
How similar studies have performed: While this study explores a relatively novel area of research, similar studies have shown the importance of psychosocial factors in chronic illness management, indicating potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 17 other locations
- University of Alabama-Birmingham — Birmingham, Alabama, United States (Recruiting)
- National Jewish Health — Denver, Colorado, United States (Recruiting)
- Northwestern University — Evanston, Illinois, United States (Not_yet_recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital/Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- University of Texas-Southwestern — Dallas, Texas, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Traci M Kazmerski, MD — Faculty
- Study coordinator: Olivia M Stransky, MPH
- Email: stranskyom@upmc.edu
- Phone: 412-648-4701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.