Lung Transplant Education for Cystic Fibrosis

Overseen By Lauren Bartlett, BS, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Inability to consent, Language barriers

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Patients' health discussion networks function to support individuals in health related matters and may provide critical support during the lung transplant journey. Increasing awareness of lung transplant, and promoting the process of deliberation and utilization of social support, could reduce the number of people with CF who die without lung transplant. Additionally, the most common patient-endorsed barrier to lung transplant discussions is a worry about being a burden on family and friends after lung transplant. For lung transplant recipients with complex post-operative courses, low social support is associated with increased mortality. Additionally, adequate social support is a requirement at all lung transplant programs in the US. Investigators are interested in understanding how caregivers may benefit from using lung transplant educational resources and how caregivers prepare for having discussions with their loved ones and/or helping them make decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether an investigator-designed research website compared to no caregiver intervention reduces caregiver burden (assessed with the Brief Assessment Scale for Caregivers, BASC), caregiver preparedness for lung transplant discussions, and caregiver lung transplant knowledge as an ancillary study in a multicenter RCT. Further, investigators will assess patient perceptions of caregiver support as measured by the Social Support Effectiveness Questionnaire (SSE-Q) and evaluate caregivers' willingness to provide support through semi-structured interviews in patient-caregiver dyads. Study involvement will span 6 months and study activities will involve the following: * Three Zoom research sessions (15-90 minutes each) * Survey assessments and an interview * Access to a research website that contains educational resources about lung transplant

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Lung Transplant Education Website safe for humans?

The research articles do not provide specific safety data for the Lung Transplant Education Website or similar educational interventions. They focus on adverse event reporting systems and their effectiveness in tracking safety issues in various medical contexts. ^{1 2 3 4 5}

How does the Lung Transplant Education for Cystic Fibrosis treatment differ from other treatments for this condition?

This treatment is unique because it focuses on educating patients about the lung transplant process through home-based video series, which helps them understand and navigate the transplant journey better. Unlike traditional treatments that focus on medical interventions, this approach emphasizes patient education and preparation, making it a novel addition to the standard care for cystic fibrosis patients awaiting lung transplants. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Lung Transplant Education Website for cystic fibrosis patients?

Research shows that educational tools like e-learning programs can improve patients' knowledge about post-transplant care, which is crucial for better outcomes. Additionally, patients found home-based video education informative and helpful, suggesting that online educational resources can be effective in preparing patients for lung transplants. ^{6 9 11 12 13}

Who Is on the Research Team?

Kathleen Ramos, MD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for caregivers or loved ones of individuals with cystic fibrosis (CF) who are enrolled in a related lung transplant study. Participants must be able to give informed consent and understand English or Spanish to complete surveys and use the educational website.

Inclusion Criteria

You are not a caregiver or family member of someone participating in the Lung Transplant READY CF 2 parent RCT study.

Someone with cystic fibrosis participating in a specific clinical trial called Lung Transplant READY CF 2.

Exclusion Criteria

I can read and understand either English or Spanish to complete surveys.

I am able to understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Caregiver participants take baseline surveys within 3 months of their loved one's enrollment in the parent Lung Transplant READY CF 2 RCT.

3 months

1 visit (virtual)

Intervention

Caregivers are randomly assigned to access the investigator-designed website or have no website access for the next three months. Surveys evaluate knowledge about lung transplant, preparedness for discussions, mental health, and caregiver burden.

3 months

3 visits (virtual)

Follow-up

Participants are monitored for changes in caregiver burden and social support effectiveness. Final surveys are completed, and caregivers gain access to the website.

3 months

1 visit (virtual)

Long-term Follow-up

Web analytics are captured to determine caregivers' usage patterns for the research website. Caregivers may be invited to participate in an interview.

up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Investigator-designed lung transplant education website

Trial Overview The trial tests an educational website designed to help caregivers of CF patients understand lung transplants, reduce caregiver burden, improve preparedness for discussions about transplantation, and increase knowledge about this treatment option.

How Is the Trial Designed?

Group I: Access to investigator-designed lung transplant education website Experimental Treatment 1 Intervention

Access to an investigator-designed web-based educational resource with information about lung transplant for three months.

Group II: No access to lung transplant education website Active Control 1 Intervention

No access to the investigator-designed lung transplant educational resource.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Published Research Related to This Trial

Lung transplant patients prioritize learning about sustaining their transplant and when to seek immediate help, indicating a strong need for comprehensive education early in the transplant process.

Patients prefer receiving information through internet resources and discussions with transplant professionals and recipients, highlighting the importance of accessible and relatable educational formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung transplant or bust: patients' recommendations for ideal lung transplant education. Davis, LA., Ryszkiewicz, E., Schenk, E., et al.[2014]

Patients who underwent lung transplants for cystic fibrosis reported significant improvements in health and quality of life, indicating the efficacy of the transplant procedure.

There is a clear need for ongoing education regarding transplant-related complications and immunosuppressive drug management, as well as support for psychological adjustment and information about new social rights post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the educational needs of lung transplant recipients with cystic fibrosis. David, V., Feldman, D., Danner-Boucher, I., et al.[2015]

A 15-minute e-learning program significantly improved lung transplant recipients' knowledge about post-transplant care compared to standard education, with participants answering more questions correctly (median 11 vs. 10).

While there was a trend towards better drug adherence in the e-learning group (71% vs. 55%), the difference was not statistically significant, indicating that while knowledge improved, it did not directly translate to adherence in this small study of 50 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An E-Learning Program Improves Patients' Knowledge After Lung Transplantation. Guldager, TB., Hyldgaard, C., Hilberg, O., et al.[2021]

A pilot study involving 17 patients and caregivers found that a home-based video series significantly improved pre-transplant education for lung transplant candidates, receiving high satisfaction ratings (4.7 out of 5).

Participants appreciated the real patient experiences shared in the videos but identified gaps in information regarding logistical aspects and concerns about medications and expenses, prompting plans to tailor future education to address these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mixed Methods Assessment of Home-Based Video Pretransplant Lung Education. Mansell, H., Fenton, ME., Tam, JS., et al.[2022]

A scoping review of 27 articles revealed that educational interventions for pediatric transplant patients, especially post-kidney transplant, significantly improved knowledge and satisfaction among patients and caregivers, but had limited impact on health-related outcomes like medication adherence.

Patients and caregivers often felt overwhelmed by the transplant process and expressed a strong desire for more information and support, highlighting the need for improved educational resources in pediatric transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of pediatric transplant education. Burghall, A., Ruhl, M., Rosaasen, N., et al.[2023]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

A systematic review of 130 studies on muscle strengthening training (MST) in youth revealed that only 33.8% reported on adverse events (AEs), highlighting a significant gap in safety monitoring during these interventions.

Among the studies that did report AEs, 40.1% documented at least one adverse event, with over half of the reported events (59.1%) linked directly to the training or testing, indicating a need for better definitions and reporting practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. Mack, DE., Anzovino, D., Sanderson, M., et al.[2023]

The study successfully mapped 11 different adverse event reporting systems related to the donation and transplantation of cells, organs, and tissues, providing a comprehensive overview of the terminology used in each system.

This scoping review, which analyzed 24 articles and materials, aims to improve future reporting systems by highlighting key features and terms, ultimately enhancing safety and efficacy in transplantation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting Systems in Cells, Organs, and Tissues Donation and Transplantation: Scoping Review. Schuantes-Paim, SM., Wachholz, LF., Knihs, NDS., et al.[2023]

In 2011, the MedWatch system received 600,000 adverse event reports, highlighting its role in improving drug and device safety awareness, but it also faces challenges with reporting bias and data accuracy.

A study analyzing 10.2 million reports found that while patient information was mostly accurate, suspect product data was often incomplete or incorrect, with significant gaps in key details like dosage and product lot numbers, which could lead to incorrect conclusions about drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. Getz, KA., Stergiopoulos, S., Kaitin, KI.[2017]

The Decision Aid developed by ASCO significantly improved the accuracy of attributing serious adverse events (SAEs) to investigational drugs, with an odds ratio of 3.60, indicating a strong potential for enhancing safety reporting.

Although the Decision Aid did not significantly affect the accuracy of determining the seriousness of AEs, most participants found it helpful and reported increased confidence and improved decision-making time, suggesting it could reduce the administrative burden in safety reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors. Mileham, KF., Schenkel, C., Chuk, MK., et al.[2020]

The Respiratory Therapy Mentoring Program successfully increased CF-specific knowledge among 37 respiratory therapists, with median knowledge scores rising from 12 to 31 after mentorship (P < .001).

Mentors' assessments of their apprentices' knowledge showed similar results, indicating that the program effectively enhanced understanding of cystic fibrosis care among new therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary evaluation of the effectiveness of the Cystic Fibrosis Foundation Mentoring Program for Respiratory Care. Richards, KM., Lester, MK., Chin, MJ., et al.[2013]

The Cystic Fibrosis Foundation plays a crucial role in advancing research and treatment for cystic fibrosis, contributing to a significant increase in the median predicted age of survival for patients.

The article emphasizes the importance of respiratory therapists in the cystic fibrosis community, highlighting their key role in patient care and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cystic fibrosis foundation: achieving the mission. Marshall, BC., Penland, CM., Hazle, L., et al.[2019]

The European Lung Foundation (ELF) focuses on educating patients about their respiratory conditions, which is crucial for effective management and prevention, highlighting the importance of knowledgeable patients in healthcare.

ELF emphasizes the need for healthcare professionals to be prepared to work with educated patients and advocates for improved educational standards at the European level, showcasing the organization's commitment to enhancing lung health through education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do patients know? Education from the European Lung Foundation perspective. Powell, P., Smyth, D., Saraiva, I., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Lung transplant or bust: patients' recommendations for ideal lung transplant education. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Identifying the educational needs of lung transplant recipients with cystic fibrosis. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

An E-Learning Program Improves Patients' Knowledge After Lung Transplantation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Mixed Methods Assessment of Home-Based Video Pretransplant Lung Education. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

A scoping review of pediatric transplant education. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting Systems in Cells, Organs, and Tissues Donation and Transplantation: Scoping Review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

A preliminary evaluation of the effectiveness of the Cystic Fibrosis Foundation Mentoring Program for Respiratory Care. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Cystic fibrosis foundation: achieving the mission. [2019]

13. England pubmed.ncbi.nlm.nih.gov

What do patients know? Education from the European Lung Foundation perspective. [2022]