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Health Outcomes of Parents With Cystic Fibrosis-Aim 2

NCT ID: NCT06296394

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-29

Study Completion Date

2031-02-01

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Parenthood Status

Keywords

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cystic fibrosis parenthood highly effective modulator therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Parenthood

The intervention group will consist of participants who became first time parents to children under 5 years of age.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Traci Kazmerski

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Traci M Kazmerski, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

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University of Alabama-Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

National Jewish Health

Denver, Colorado, United States

Site Status RECRUITING

Northwestern University

Evanston, Illinois, United States

Site Status NOT_YET_RECRUITING

Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Boston Children's Hospital/Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

University of Texas-Southwestern

Dallas, Texas, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Olivia M Stransky, MPH

Role: CONTACT

Phone: 412-648-4701

Email: [email protected]

Facility Contacts

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Alexandra Wilson

Role: primary

Megan Behrman

Role: primary

Shivani Patel

Role: primary

Nivedita Chaudhary

Role: primary

Jonathan Greenberg

Role: primary

Dena Johnson

Role: primary

Elisabeth Dellon

Role: primary

Ashley Keller

Role: primary

Roshni Prabhu

Role: primary

Other Identifiers

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1R01HL161164-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KAZMER22A0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY23080161

Identifier Type: -

Identifier Source: org_study_id