Health Outcomes of Parents With Cystic Fibrosis-Aim 2

(HOPeCF Trial)

Recruiting at 17 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?

The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are: H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression. H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.

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+