HOPeCF: Health Outcomes of Parents With Cystic Fibrosis

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05829694
• Collaborator: Cystic Fibrosis Foundation (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 996
• Locations: 7
• Anticipated Duration (Months): 14
• Patients Per Site: 142.3
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis; Parenthood Status	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 Design

• Study Type: Observational
• Anticipated Enrollment: 996 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Health Outcomes of Parents With Cystic Fibrosis (HOPeCF): A Retrospective Analysis of Impact of Parenthood on Lung Function
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. FEV1 [2012-2022]

   Rate of decline of ppFEV1 as reported in the CFFPR

Secondary Outcome Measures

1. Rate of pulmonary exacerbations [2012-2022]

   Rate of pulmonary exacerbations as reported in the CFFPR

2. Rate of hospitalizations [2012-2022]

   Rate of hospitalizations as reported in the CFFPR

3. Clinic visit attendance [2012-2022]

   Clinic visit attendance as reported in the CFFPR

4. BMI [2012-2022]

   BMI as reported in the CFFPR

5. Medication Use [2012-2022]

   Medication use as reported in the CFFPR

6. CFRD Control [2012-2022]

   HbgA1c as reported in the CFFPR

7. Microbiologic profile [2012-2022]

   Presence of specific types of bacteria, mycobacteria, fungus in cultures as reported in the CFFPR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Jewish Health	Denver	Colorado	United States	80206
2	Johns Hopkins University	Baltimore	Maryland	United States	21218
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	University of Minnesota	Minneapolis	Minnesota	United States	55455
5	University of North Carolina	Chapel Hill	North Carolina	United States	27599
6	University of Texas-Southwestern	Dallas	Texas	United States	75390
7	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Traci M Kazmerski, MD, MS, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Traci Kazmerski, Assistant Professor of Pediatrics, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT05829694
• Other Study ID Numbers: STUDY22010135; 1R01HL161164-01A1; KAZMER22A0
• First Posted: Apr 26, 2023
• Last Update Posted: Apr 26, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Traci Kazmerski, Assistant Professor of Pediatrics, University of Pittsburgh: cystic fibrosis; parenthood; highly-effective modulator therapy
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Apr 26, 2023