Cystic Fibrosis Reproductive and Sexual Health Collaborative: Building Online Research Partnerships

• Conditions: Cystic Fibrosis; Patient Engagement

• Registration Number: NCT04999865
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2019-04-19
• Primary Completion: 2020-08-15
• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-11
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-19
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 100

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.

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Exclusion Criteria

• Persons less than 18 years of age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in knowledge, confidence and satisfaction regarding patient-engagement methodology	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	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States