Health Outcomes of Parents With Cystic Fibrosis

NCT ID: NCT05829694

Last Updated: 2024-09-19

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

COMPLETED

Total Enrollment

956 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-12

Study Completion Date

2024-08-12

Brief Summary

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This project will determine the health impact of parenthood on people with cystic fibrosis (CF). The study team will use retrospective data to provide relatively immediate evidence on parenthood's effect on pulmonary health.

Detailed Description

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This co-funded study sponsored by the National Institutes of Health and the CF Foundation (CFF) will seek to determine the health impact of parenthood on people with CF in the era of CF transmembrane conductance regulator (CFTR) modulators. To provide relatively immediate evidence on parenthood's effect on pulmonary health and the influence of the introduction and use of all available CFTR modulators, in Aim 1 the study team will assess changes in pre- vs. intra-parenthood percent predicted forced expiratory volume in 1 second (ppFEV1) in a retrospective longitudinal cohort study linking CFF patient registry (CFFPR) data with cross-sectional surveys collected from 249 new parents attending participating United States CF centers between 2012-2022. The study team will identify predictors and timing of lung function loss using 747 non-parents from participating centers as a comparison group and examine the impact of CFTR modulators on parental health.

Conditions

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Cystic Fibrosis Parenthood Status

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Parents

Individuals diagnosed with cystic fibrosis who became a first-time parent between January 1, 2012 and December 31, 2022.

Parental Status

Intervention Type OTHER

The aim of the study is to assess the impact parenthood has on health outcomes.

Non-parents

Individuals diagnosed with cystic fibrosis who have never been a parent.

No interventions assigned to this group

Interventions

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Parental Status

The aim of the study is to assess the impact parenthood has on health outcomes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed CF diagnosis with sweat or genotype analysis
* Participant in the CFFPR
* Became a first-time parent between the years 2012-2022 (exposure arm only)

Exclusion Criteria

* Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)
* 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 of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Traci M Kazmerski, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

UPMC

Pittsburgh, Pennsylvania, United States

Site Status

University of Texas-Southwestern

Dallas, Texas, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

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

STUDY22010135

Identifier Type: -

Identifier Source: org_study_id

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