Clinical trial NCT04999865: Cystic Fibrosis Reproductive and Sexual Health Collaborative: Building Online Research Partnerships
Official title: Building Online Research Partnerships to Improve Sexual and Reproductive Health for Women With Cystic Fibrosis (CF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Patient Engagement
Keywords: Cystic Fibrosis
Education
Patient engaged research
Training
Evaluation
Patient
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-08-11
Enrollment: 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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:

1. build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
2. create and disseminate a best practices PCOR user guide for populations that solely engage online,
3. to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
4. 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:

1. build capacity for PCOR knowledge and skills applicable for longitudinal online engagement,
2. create and disseminate a best practices PCOR user guide for populations that solely engage online,
3. to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and
4. to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Persons less than 18 years of age

Primary outcomes:
measure: Change in knowledge, confidence and satisfaction regarding patient-engagement methodology
timeFrame: four separate training programs over the course of a year
measure: Development of step-by-step training manual
timeFrame: March 2021-December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Emily M Godfrey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.