Parenthood Impact on Health for Cystic Fibrosis

(HOPeCF Trial)

Recruiting at 18 trial locations

Overseen By Olivia M Stransky, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: CFTR modulators

Disqualifiers: Lung transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how becoming a parent affects people in the U.S. with cystic fibrosis (CF), particularly those using CFTR modulators, common CF treatments. Researchers aim to determine if having CF, combined with depression or high parental stress, accelerates lung function decline. They also seek to understand if CFTR modulators help slow this decline. Ideal participants are new parents with CF who have not undergone a lung transplant and became a parent to a child under five in the last six months. As an unphased trial, this study allows participants to contribute to understanding the broader impacts of CF treatments on new parents.

Why are researchers excited about this trial?

This trial is noteworthy because it explores the health outcomes of parents with cystic fibrosis, a unique focus compared to traditional studies that often concentrate solely on patients themselves. Researchers are excited about this trial because it aims to uncover how being a parent might influence the health and well-being of individuals with cystic fibrosis. This could lead to a better understanding of the social and psychological factors that affect health outcomes, potentially opening doors to more holistic and personalized care strategies for patients managing both cystic fibrosis and parenthood.

Who Is on the Research Team?

Traci M Kazmerski, MD

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with cystic fibrosis through a sweat test or genetic testing.

I became a parent to a child under 5 in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Data Collection

Participants complete quarterly surveys during the first year of parenthood and biannual surveys thereafter to assess health impacts.

5 years

Quarterly visits in Year 1, biannual visits in Years 2-5

Follow-up

Participants are monitored for changes in health outcomes, including ppFEV1 and other health measures.

5 years

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+