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?

This trial aims to determine if an educational website can help caregivers of people with cystic fibrosis (CF) better understand and discuss lung transplants. Lung transplants can be life-saving for those with severe lung disease from CF, but many aren't referred or choose not to pursue this option. The study will compare caregivers who use the investigator-designed lung transplant education website with those who don't, assessing whether it reduces stress and improves preparedness and knowledge. It suits caregivers of individuals with CF enrolled in a related study who can read English or Spanish. Participants will engage in three Zoom sessions, complete surveys, and possibly participate in an interview over six months. As an unphased trial, this study offers caregivers a unique opportunity to contribute to research that could enhance support and resources for others in similar situations.

Will I have to stop taking my current medications?

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

What prior data suggests that this lung transplant education website is safe for caregivers?

Research has shown that people with cystic fibrosis (CF) who have had lung transplants often feel much healthier and happier, indicating the procedure's effectiveness for many. However, this study does not test a new drug or surgery. Instead, it focuses on an educational website designed to help caregivers learn more about lung transplants.

Since this study involves sharing information rather than providing medical treatment, it does not carry the same safety concerns as trials for new drugs or surgeries. The website aims to reduce caregiver stress and offer better support for those considering a lung transplant, making it a safer option compared to other medical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to empower patients with cystic fibrosis who might need a lung transplant. Unlike standard treatments that focus on medical procedures and medications, this trial tests an educational approach using a web-based resource specifically designed to inform patients about lung transplants. This method could enhance patient understanding and engagement, potentially improving their preparation and decision-making regarding transplants. By focusing on education, the trial aims to address the gap in patient knowledge and support, which is not typically covered by existing medical treatments.

What evidence suggests that this lung transplant education website is effective for reducing caregiver burden in cystic fibrosis?

This trial will compare the effects of providing access to an investigator-designed lung transplant education website with not providing access. Research has shown that good education about lung transplants helps patients make informed choices and leads to better outcomes after the transplant. Personal stories from people with cystic fibrosis (CF) who have had lung transplants help about 74% of others understand and make decisions. Lung transplants can extend life and improve quality of life, but many CF patients with severe lung disease die before receiving a transplant. Educational resources are designed to help caregivers discuss and decide on lung transplants. By raising awareness and providing support, these resources aim to reduce the number of CF patients who die without receiving a lung transplant. ^{1 5 6 7 8}

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

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]

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]

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]

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]

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]

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]

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 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 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 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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9748576/

Take on transplant: human-centered design of a patient ...

Lung transplantation (LTx) can improve survival and quality of life,, but nearly 40% of US CF patients with advanced lung disease die before ...

2.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06030206?draw=2&rank=1

Lung Transplant READY CF 2: A Multi-site RCT

In the United States, more people with CF with forced expiratory volume in 1 second (FEV1) less than 30% of predicted die each year than undergo lung ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0738399125001892

Personal narratives to support learning about lung ...

Personal narratives from lung transplant recipients with CF enhance knowledge and preparedness for LTx among PwCF. · Decision-making preparedness improved for 74 ...

4.

withpower.com

withpower.com/trial/phase-cystic-fibrosis-8-2023-6061f

Lung Transplant Education for Cystic Fibrosis

Research shows that effective lung transplant education helps patients make informed decisions and leads to better transplant outcomes. Additionally, an e- ...

5.

atsjournals.org

atsjournals.org/doi/full/10.1513/AnnalsATS.202307-625OC

Qualitative Analysis of Perspectives on Lung Transplant ...

Rationale: Lung transplant (LTx) is a potentially lifesaving treatment option for individuals with advanced cystic fibrosis (CF), ...

6.

withpower.com

withpower.com/trial/phase-cystic-fibrosis-8-2023-25f92

Lung Transplant Education for Cystic Fibrosis

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

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0041134522002135

Results of Lung Transplantations Among Cystic Fibrosis ...

We describe good survival outcomes as 85% of our patients reaching 1-year follow-up and 75% of them surviving at least 3 years after the procedure. These ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11256549/

Attitudes toward and preparedness for lung transplantation ...

Outcomes for individuals with cystic fibrosis (CF) have improved due to highly effective modulator therapy (HEMT). However, lung transplant ...