Health Outcomes of Parents With Cystic Fibrosis
HOPeCF
3 other identifiers
observational
956
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2024
CompletedSeptember 19, 2024
September 1, 2024
1.1 years
March 8, 2023
September 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1
Rate of decline of ppFEV1 as reported in the CFFPR
2012-2022
Secondary Outcomes (7)
Rate of pulmonary exacerbations
2012-2022
Rate of hospitalizations
2012-2022
Clinic visit attendance
2012-2022
BMI
2012-2022
Medication Use
2012-2022
- +2 more secondary outcomes
Study Arms (2)
Parents
Individuals diagnosed with cystic fibrosis who became a first-time parent between January 1, 2012 and December 31, 2022.
Non-parents
Individuals diagnosed with cystic fibrosis who have never been a parent.
Interventions
The aim of the study is to assess the impact parenthood has on health outcomes.
Eligibility Criteria
Individuals with cystic fibrosis who are participants in the Cystic Fibrosis Foundation's Patient Registry.
You may qualify if:
- 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)
You may not qualify if:
- Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)
- Does not speak/read English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Cystic Fibrosis Foundationcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (8)
National Jewish Health
Denver, Colorado, 80206, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
University of Texas-Southwestern
Dallas, Texas, 75390, United States
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Traci M Kazmerski, MD, MS
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
March 8, 2023
First Posted
April 26, 2023
Study Start
July 12, 2023
Primary Completion
August 12, 2024
Study Completion
August 12, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share