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

NCT04999865 | Unknown

• 1 other identifier: STUDY00006146
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Cystic Fibrosis; Education; Patient engaged research; Training; Evaluation; Patient

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  March 2021-December 2021

Interventions

4-part educational program to build patient-engagement methodology capacity OTHER

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Persons less than 18 years of age

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 34863273 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Patient Participation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Emily M Godfrey, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 11, 2021
• Study Start: April 19, 2019
• Primary Completion: August 15, 2020
• Study Completion: December 31, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)