Health Outcomes of Parents With Cystic Fibrosis-Aim 2
HOPeCF
3 other identifiers
observational
146
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2024
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedStudy Start
First participant enrolled
May 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2031
November 10, 2025
November 1, 2025
5.7 years
February 28, 2024
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced Expiratory Volume (FEV1)
Rate of change in ppFEV1 as reflected in the medical record from Year 1 to Year 5
Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5
Secondary Outcomes (33)
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
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 Diagnosis
Year 1
History of CF Genotype Information
Year 1
- +28 more secondary outcomes
Interventions
The intervention group will consist of participants who became first time parents to children under 5 years of age.
Eligibility Criteria
Individuals with cystic fibrosis who have become first-time parents to a child under 5 years of age.
You may qualify if:
- 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
You may not qualify if:
- Undergone a lung transplant
- Does not speak/read English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Cystic Fibrosis Foundationcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (18)
University of Alabama-Birmingham
Birmingham, Alabama, 35294, United States
National Jewish Health
Denver, Colorado, 80206, United States
Northwestern University
Evanston, Illinois, 60208, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital/Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas-Southwestern
Dallas, Texas, 75390, United States
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Traci M Kazmerski, MD
Faculty
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 6, 2024
Study Start
May 29, 2024
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
February 1, 2031
Last Updated
November 10, 2025
Record last verified: 2025-11