Cystic FibrosisHOPeCFNCT05829694
Health Outcomes of Parents With Cystic Fibrosis
An observational study of Cystic Fibrosis and Parenthood Status, run by University of Pittsburgh at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Parenthood Status
- What is being tested?
- Parental Status
- How many people
- 956 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Jul 2023to 12 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with cystic fibrosis who are participants in the Cystic Fibrosis Foundation's Patient Registry.
Who may be able to join
- 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)
Who cannot join
- Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)
- Does not speak/read English or Spanish
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Texas-Southwestern
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
University of Minnesota
Minneapolis, Minnesota, 55455
UPMC
Pittsburgh, Pennsylvania, 15213
University of Washington
Seattle, Washington, 98195
About this study
Official title: Health Outcomes of Parents With Cystic Fibrosis (HOPeCF): A Retrospective Analysis of Impact of Parenthood on Lung Function
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.
Read the detailed description
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.
- Conditions
- Cystic Fibrosis, Parenthood Status
- Being tested
- Parental Status
- Keywords
- cystic fibrosis, parenthood, highly-effective modulator therapy
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental StatusOther
The aim of the study is to assess the impact parenthood has on health outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Parents | Individuals diagnosed with cystic fibrosis who became a first-time parent between January 1, 2012 and December 31, 2022. Receives: Other: Parental Status | |
| Non-parents | Individuals diagnosed with cystic fibrosis who have never been a parent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Rate of decline of ppFEV1 as reported in the CFFPR
Measured: 2012-2022
Secondary outcomes (7)
Rate of pulmonary exacerbations
Rate of pulmonary exacerbations as reported in the CFFPR
Measured: 2012-2022
Rate of hospitalizations
Rate of hospitalizations as reported in the CFFPR
Measured: 2012-2022
Clinic visit attendance
Clinic visit attendance as reported in the CFFPR
Measured: 2012-2022
BMI
BMI as reported in the CFFPR
Measured: 2012-2022
Medication Use
Medication use as reported in the CFFPR
Measured: 2012-2022
CFRD Control
HbgA1c as reported in the CFFPR
Measured: 2012-2022
Microbiologic profile
Presence of specific types of bacteria, mycobacteria, fungus in cultures as reported in the CFFPR
Measured: 2012-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start12 Jul 2023
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 956 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Traci Kazmerski, University of Pittsburgh
- Investigators
- Traci M Kazmerski, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829694
- Sponsor's protocol ID
- STUDY22010135
- Other IDs
- 1R01HL161164-01A1, KAZMER22A0
- Acronym
- HOPeCF
- Status last verified
- Sep 2024
- First submitted
- 8 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes of Parents With Cystic Fibrosis (HOPeCF): A Retrospective Analysis of Impact of Parenthood on Lung Function
- ClinicalTrials.gov ID
- NCT05829694
- Acronym / sponsor ID
- HOPeCF / STUDY22010135
- Conditions
- Cystic Fibrosis, Parenthood Status
- Keywords
- cystic fibrosis, parenthood, highly-effective modulator therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 956 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Parental StatusIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with cystic fibrosis who are participants in the Cystic Fibrosis Foundation's Patient Registry.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)
- Does not speak/read English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental StatusThe aim of the study is to assess the impact parenthood has on health outcomes. | Other | Parents |
Primary outcome
FEV1
Time frame: 2012-2022
Rate of decline of ppFEV1 as reported in the CFFPR
7 secondary outcomes
Rate of pulmonary exacerbations
Time frame: 2012-2022
Rate of hospitalizations
Time frame: 2012-2022
Clinic visit attendance
Time frame: 2012-2022
BMI
Time frame: 2012-2022
Medication Use
Time frame: 2012-2022
CFRD Control
Time frame: 2012-2022
Microbiologic profile
Time frame: 2012-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Traci M Kazmerski, MD, MS principal investigator
University of Pittsburgh
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Parenthood Status, run by University of Pittsburgh at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: 2012-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.