Health Outcomes of Parents With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— HOPeCF  

Official title:

Health Outcomes of Parents With Cystic Fibrosis (HOPeCF): A Retrospective Analysis of Impact of Parenthood on Lung Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829694
• Other study ID #: STUDY22010135
• Secondary ID: 1R01HL161164-01A
• Status: Recruiting
• Start date: July 12, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Olivia M Stransky, MPH
• Phone: 412-648-4701
• Email: stranskyom[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 996
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Parenthood Status

Intervention

Other:
• Parental Status
The aim of the study is to assess the impact parenthood has on health outcomes.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Texas-Southwestern	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	University of Minnesota	Minneapolis	Minnesota
United States	UPMC	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1	Rate of decline of ppFEV1 as reported in the CFFPR	2012-2022
Secondary	Rate of pulmonary exacerbations	Rate of pulmonary exacerbations as reported in the CFFPR	2012-2022
Secondary	Rate of hospitalizations	Rate of hospitalizations as reported in the CFFPR	2012-2022
Secondary	Clinic visit attendance	Clinic visit attendance as reported in the CFFPR	2012-2022
Secondary	BMI	BMI as reported in the CFFPR	2012-2022
Secondary	Medication Use	Medication use as reported in the CFFPR	2012-2022
Secondary	CFRD Control	HbgA1c as reported in the CFFPR	2012-2022
Secondary	Microbiologic profile	Presence of specific types of bacteria, mycobacteria, fungus in cultures as reported in the CFFPR	2012-2022