Health Outcomes of Parents With Cystic Fibrosis

Study Overview
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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.

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

Conditions
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Cystic Fibrosis, Parenthood Status

Intervention / Treatment
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* Other: Parental Status


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents<br>Individuals diagnosed with cystic fibrosis who became a first-time parent between January 1, 2012 and December 31, 2022. | Other: Parental Status<br>* The aim of the study is to assess the impact parenthood has on health outcomes.<br>|
| Non-parents<br>Individuals diagnosed with cystic fibrosis who have never been a parent. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, parenthood, highly-effective modulator therapy