Cystic FibrosisNCT04999865
Cystic Fibrosis Reproductive and Sexual Health Collaborative: Building Online Research Partnerships
An observational study of Cystic Fibrosis and Patient Engagement, run by University of Washington at 1 site in United States.
Trial summary
This is a Patient-Centered Outcomes Research Institute engagement effort aimed at training researchers/providers and patients to work in research teams together online throughout the research process (including: development, design, and dissemination) to address critical gaps in their care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis, Patient Engagement
- What is being tested?
- 4-part educational program to build patient-engagement methodology capacity
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 31 Dec 2021
- 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 Any age
- Child, Adult, Older adult
Study population: Eligible participants are members of the CF community (patients, caregivers, researchers, providers or other stakeholders) who have an interest in learning more about patient-engaged methodology.
Who may be able to join
- Any interested adult CF patients, CF caregivers, researchers or healthcare providers can be included in the online patient-engagement training program. Any interested patients/community members and researchers/providers involved in patient-centered outcomes reserach teams that engage online can be included for the online platform interviews.
Who cannot join
- Persons less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Online Research Partnerships to Improve Sexual and Reproductive Health for Women With Cystic Fibrosis (CF)
This is a Patient-Centered Outcomes Research Institute engagement effort aimed at training researchers/providers and patients to work in research teams together online throughout the research process (including: development, design, and dissemination) to address critical gaps in their care. This is a change from the typical research done with people with CF as they are frequently isolated from other members of the CF community because of infection control guidelines that restrict in-person contact to avoid the spread of bacteria between patients.
This project has four aims:
- build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
- create and disseminate a best practices PCOR user guide for populations that solely engage online,
- to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
- to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.
Read the detailed description
The CF Reproductive and Sexual Health Collaborative (CFReSHC) will introduce and support patient-centered outcomes research (PCOR) to the greater CF community using existing PCOR training products and adapt them so that they address key issues related to researcher-patient teams that solely engage online. We will create a best-practices user guide for online engagement by performing key-informant interviews with patient- or community-engaged teams and periodic assessments of day-to-day platform use with CFReSHC members and other PCOR teams.
This project has four aims:
- build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
- create and disseminate a best practices PCOR user guide for populations that solely engage online,
- to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
- to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.
- Conditions
- Cystic Fibrosis, Patient Engagement
- Being tested
- 4-part educational program to build patient-engagement methodology capacity
- Keywords
- Cystic Fibrosis, Education, Patient engaged research, Training, Evaluation, Patient
- Medical subject headings
- Cystic Fibrosis, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-part educational program to build patient-engagement methodology capacityOther
We created four online training sessions. Our first training for patients/caregivers only (Research 101) was an exception, however, in which we produced a 25-minute asynchronous, self-directed learning seminar intended to be viewed before the subsequent interactive PCOR sessions. Of the three following synchronous interactive training sessions, two included both learner working groups (patients/caregivers and researchers/providers) together (PCOR 101 and PCOR Team Dynamics) and one session (PCOR Study Design) was for researchers/healthcare providers only.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge, confidence and satisfaction regarding patient-engagement methodology
we evaluated each of our training sessions by administering a survey to participants before the training and another similar survey immediately after the training. For both the pre- and post-training surveys, we asked participants to rate their agreement about PCOR knowledge, confidence about engaging in PCOR and training session satisfaction (post-training only) using a 5 option Likert scale. Participants were given a statement related to the learning objective and asked to rate how much they agreed with the statement with options ranging from strongly disagree, disagree, neutral, agree and strongly agree. At the end of each survey, we asked open-ended questions regarding what the participants liked about the training session and how we could improve. Surveys were administered online via REDCap.
Measured: four separate training programs over the course of a year
Development of step-by-step training manual
3)4) 12-15 CF and PCOR community stakeholders, selected through an application process, will attend monthly virtual meetings to provide feedback on the development of the PCOR training manual.
Measured: March 2021-December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start19 Apr 2019
- Primary completion15 Aug 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Emily Godfrey, University of Washington
- Investigators
- Emily M Godfrey, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999865
- Sponsor's protocol ID
- STUDY00006146
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared
Publications
Godfrey EM, Thayer EK, Mentch L, Kazmerski TM, Brown G, Pam M, Al Achkar M. Development and evaluation of a virtual patient-centered outcomes research training program for the cystic fibrosis community. Res Involv Engagem. 2021 Dec 4;7(1):86. doi: 10.1186/s40900-021-00328-4.
PubMed 34863273
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Online Research Partnerships to Improve Sexual and Reproductive Health for Women With Cystic Fibrosis (CF)
- ClinicalTrials.gov ID
- NCT04999865
- Acronym / sponsor ID
- STUDY00006146
- Conditions
- Cystic Fibrosis, Patient Engagement
- Keywords
- Cystic Fibrosis, Education, Patient engaged research, Training, Evaluation, Patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Aug 2021 (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 is a Patient-Centered Outcomes Research Institute engagement effort aimed at training researchers/providers and patients to work in research teams together online throughout the research process (including: development, design, and dissemination) to address critical gaps in their care. This is a change from the typical research done with people with CF as they are frequently isolated from other members of the CF community because of infection control guidelines that restrict in-person contact to avoid the spread of bacteria between patients.
This project has four aims:
- build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
- create and disseminate a best practices PCOR user guide for populations that solely engage online,
- to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
- to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.
Detailed description
The CF Reproductive and Sexual Health Collaborative (CFReSHC) will introduce and support patient-centered outcomes research (PCOR) to the greater CF community using existing PCOR training products and adapt them so that they address key issues related to researcher-patient teams that solely engage online. We will create a best-practices user guide for online engagement by performing key-informant interviews with patient- or community-engaged teams and periodic assessments of day-to-day platform use with CFReSHC members and other PCOR teams.
This project has four aims:
- build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
- create and disseminate a best practices PCOR user guide for populations that solely engage online,
- to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
- to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible participants are members of the CF community (patients, caregivers, researchers, providers or other stakeholders) who have an interest in learning more about patient-engaged methodology.
Key inclusion criteria (1 listed)
- Any interested adult CF patients, CF caregivers, researchers or healthcare providers can be included in the online patient-engagement training program. Any interested patients/community members and researchers/providers involved in patient-centered outcomes reserach teams that engage online can be included for the online platform interviews.
Key exclusion criteria (1 listed)
- Persons less than 18 years of age
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 |
|---|---|---|
| 4-part educational program to build patient-engagement methodology capacityWe created four online training sessions. Our first training for patients/caregivers only (Research 101) was an exception, however, in which we produced a 25-minute asynchronous, self-directed learning seminar intended to be viewed before the subsequent interactive PCOR sessions. Of the three following synchronous interactive training sessions, two included both learner working groups (patients/caregivers and researchers/providers) together (PCOR 101 and PCOR Team Dynamics) and one session (PCOR Study Design) was for researchers/healthcare providers only. | Other | – |
Primary outcome
Change in knowledge, confidence and satisfaction regarding patient-engagement methodology
Time frame: four separate training programs over the course of a year
we evaluated each of our training sessions by administering a survey to participants before the training and another similar survey immediately after the training. For both the pre- and post-training surveys, we asked participants to rate their agreement about PCOR knowledge, confidence about engaging in PCOR and training session satisfaction (post-training only) using a 5 option Likert scale. Participants were given a statement related to the learning objective and asked to rate how much they agreed with the statement with options ranging from strongly disagree, disagree, neutral, agree and strongly agree. At the end of each survey, we asked open-ended questions regarding what the participants liked about the training session and how we could improve. Surveys were administered online via REDCap.
Development of step-by-step training manual
Time frame: March 2021-December 2021
3)4) 12-15 CF and PCOR community stakeholders, selected through an application process, will attend monthly virtual meetings to provide feedback on the development of the PCOR training manual.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 34863273Godfrey EM, Thayer EK, Mentch L, Kazmerski TM, Brown G, Pam M, Al Achkar M. Development and evaluation of a virtual patient-centered outcomes research training program for the cystic fibrosis community. Res Involv Engagem. 2021 Dec 4;7(1):86. doi: 10.1186/s40900-021-00328-4.
- Individual participant dataSharing planned: No. individual participant data will not be shared
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Emily M Godfrey, MD, MPH principal investigator
University of Washington
1 site 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 Patient Engagement, run by University of Washington at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Change in knowledge, confidence and satisfaction regarding patient-engagement methodology (time frame: four separate training programs over the course of a year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999865, which also lists 1 linked publication.
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 Aug 2021.