Health Outcomes of Parents With Cystic Fibrosis (HOPeCF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis; Parenthood Status
• Intervention / Treatment: Other: Parental Status

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 996

Contacts and Locations

• Study Contact: Name: Traci M Kazmerski, MD, MS; Email: traci.kazmerski@chp.edu
• Study Contact Backup: Name: Olivia M Stransky, MPH; Phone Number: 412-648-4701; Email: stranskyom@upmc.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • Completed
      • National Jewish Health
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Johns Hopkins University
      • Principal Investigator: Natalie West, MD, MPH
      • Contact: Shivani Patel; Email: spate156@jhmi.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Completed
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Dena Johnson; Email: joh20459@umn.edu
      • Principal Investigator: Joanne Billings, MD, MPH
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina
      • Contact: Elisabeth Dellon; Email: elisabeth_dellon@med.unc.edu
      • Principal Investigator: Elisabeth Dellon, MD, MPH
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Completed
      • UPMC
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas-Southwestern
      • Contact: Ashley Keller; Email: Ashley.Keller@UTSouthwestern.edu
      • Principal Investigator: Raksha Jain, MD
  • Washington
    • Seattle, Washington, United States, 98195
      • Completed
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with cystic fibrosis who are participants in the Cystic Fibrosis Foundation's Patient Registry.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parents; Individuals diagnosed with cystic fibrosis who became a first-time parent between January 1, 2012 and December 31, 2022.	Other: Parental Status; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1	Rate of decline of ppFEV1 as reported in the CFFPR	2012-2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of pulmonary exacerbations	Rate of pulmonary exacerbations as reported in the CFFPR	2012-2022
Rate of hospitalizations	Rate of hospitalizations as reported in the CFFPR	2012-2022
Clinic visit attendance	Clinic visit attendance as reported in the CFFPR	2012-2022
BMI	BMI as reported in the CFFPR	2012-2022
Medication Use	Medication use as reported in the CFFPR	2012-2022
CFRD Control	HbgA1c as reported in the CFFPR	2012-2022
Microbiologic profile	Presence of specific types of bacteria, mycobacteria, fungus in cultures as reported in the CFFPR	2012-2022

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Cystic Fibrosis Foundation
• Investigators: Principal Investigator: Traci M Kazmerski, MD, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: cystic fibrosis; parenthood; highly-effective modulator therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: STUDY22010135; 1R01HL161164-01A1 (U.S. NIH Grant/Contract); KAZMER22A0 (Other Grant/Funding Number: Cystic Fibrosis Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No