Health Outcomes of Parents With Cystic Fibrosis-Aim 2

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Pittsburgh
Study ID
NCT06296394
Status
Recruiting
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Conditions

  • Cystic Fibrosis
  • Parenthood Status

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Parenthood — OTHER
    The intervention group will consist of participants who became first time parents to children under 5 years of age.

Study Details

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.

Key Dates

Start date
May 29, 2024
Status verified
Nov 2025
Primary completion
Feb 1, 2030
Completion
Feb 1, 2031

Study Design

Enrollment
146 participants (estimated)

Primary Outcome Measure

Forced Expiratory Volume (FEV1) [ Time Frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5 ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama-BirminghamBirminghamAlabama35294
George M Solomon, MD (PRINCIPAL_INVESTIGATOR)
National Jewish HealthDenverColorado80206
Alexandra Wilson
[email protected]
Jennifer Taylor-Cousar, MD, MSCS (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityEvanstonIllinois60208
Manu Jain, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Cynthia Brown, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Megan Behrman
[email protected]
Amanda Bruce, PhD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21218
Shivani Patel
[email protected]
Natalie West, MD, MPH (PRINCIPAL_INVESTIGATOR)
Boston Children's Hospital/Brigham and Women's HospitalBostonMassachusetts02115
Jonathan Greenberg
[email protected]
Manuela Cernadas, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Nivedita Chaudhary
[email protected]
Anna Georgiopoulos, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Shijing Jia, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Dena Johnson
[email protected]
Joanne Billings, MD, MPH (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Daniel Rosenbluth, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Elisabeth Dellon
[email protected]
Elisabeth Dellon, MD, MPH (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Aaron Trimble, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Denis Hadjiliadis, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213-
Medical University of South CarolinaCharlestonSouth Carolina29425
Patrick Flume, MD (PRINCIPAL_INVESTIGATOR)
University of Texas-SouthwesternDallasTexas75390
Ashley Keller
[email protected]
Raksha Jain, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Roshni Prabhu
[email protected]
Kathleen Ramos, MD, MS (PRINCIPAL_INVESTIGATOR)

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