Lung Transplant Education for Cystic Fibrosis

Recruiting at 10 trial locations

Overseen By Lauren Bartlett, BS, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Lung transplant recipients, others

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

Compensation: Varies

Number of Visits: 2

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specially designed website helps people with cystic fibrosis (CF) feel more prepared to discuss lung transplants with their doctors. CF can severely affect the lungs, and transplants may be crucial for those with very low lung function. Participants will access educational resources, including an investigator-designed lung transplant education resource and publicly available transplant education materials, and engage in discussions to better understand transplant options, particularly for communities with historically less access to this treatment. Ideal candidates have been diagnosed with CF and have lung function below 50% of the expected level. The trial includes online sessions, surveys, and recordings of doctor visits to track how lung transplants are discussed. As an unphased trial, this study offers participants the chance to contribute to innovative educational tools that may enhance future discussions about lung transplants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education and discussions about lung transplants rather than medication changes.

What prior data suggests that this educational resource is safe for use in lung transplant education?

Research has shown that educational resources for lung transplants, like the one tested in this study, help patients with cystic fibrosis (CF) understand their options and make informed decisions. These resources focus on education rather than medical treatments, so they don't include specific safety data.

The tools aim to teach people with CF about lung transplants, a crucial option for those with severe lung disease. While these resources don't involve taking medicine or undergoing procedures, they prepare individuals for important discussions about their treatment choices.

Since this trial focuses on education, it poses no safety risks or side effects like those associated with medical treatments. It centers on providing the right information to support informed decision-making. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lung Transplant Education resources for cystic fibrosis because they aim to enhance patient understanding and empowerment. Unlike standard transplant education, which often relies on publicly available resources, this trial includes a specially designed web-based educational tool crafted by investigators. This custom resource is tailored to address specific needs and concerns of patients with cystic fibrosis, potentially offering more relevant and comprehensive information. By providing targeted education, the hope is to improve patient decision-making and outcomes related to lung transplants.

What evidence suggests that this trial's educational resources could be effective for improving lung transplant discussions in cystic fibrosis?

This trial will compare two educational resources for people with cystic fibrosis (CF) considering lung transplants. Participants in one group will use an investigator-designed web-based educational resource. Previous research has shown that this resource can help people with CF better understand lung transplants by addressing patient-identified knowledge gaps. Participants in the other group will use a publicly available web-based educational resource. Both resources aim to prepare patients for discussions about lung transplant options. By increasing awareness, these resources may encourage more people with CF to consider lung transplants as a possible treatment, especially in areas with limited access to transplant opportunities. ^{1 2 6 7 8}

Who Is on the Research Team?

Kathleen Ramos, MD, MSc

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for individuals with cystic fibrosis whose lung function (FEV1) is less than half of what's expected. It's not open to those who've already had a lung transplant, can't consent for themselves, or don't understand English or Spanish well enough to use the resources and complete surveys.

Inclusion Criteria

Your lung function test shows that you can only exhale less than half of what is expected for someone your age and size.

I have been diagnosed with cystic fibrosis.

Exclusion Criteria

You have had a lung transplant.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to one of two educational resources and have access to the assigned resource for three months.

3 months

1 visit (virtual) at 2 weeks, 1 visit (in-person) at 2-3 months

Follow-up

Participants are monitored for preparedness and knowledge about lung transplant, with surveys conducted at 3 and 6 months.

3 months

1 visit (virtual) at 3 months, 1 visit (virtual) at 6 months

Long-term Follow-up

Web analytics are captured for a long-term follow-up period to determine usage patterns of educational resources.

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Investigator-designed lung transplant education resource
• Publicly available transplant education resource

Trial Overview

The study compares two educational resources on lung transplants: one designed by researchers and another that's publicly available. Over six months, participants will have Zoom sessions, take surveys, access a research website with educational content, and have a clinic visit audio-recorded to see how transplant talks are handled.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Attention-control Active Control 1 Intervention

Access to a publicly available web-based educational resource with information about transplant for three months.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

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]

A survey of 67 pediatric cystic fibrosis care programs revealed that while most teams actively address school-related concerns, only 19% have formal education risk assessments and support programs in place.

There is a significant gap in resources for education-related needs, with high demand for informational materials and staff training, indicating that improving these areas could enhance support for patients and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education-related needs for children with cystic fibrosis: Perspectives of US pediatric care teams. Hjelm, M., Hente, E., Schuler, CL., et al.[2023]

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]

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]

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]

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]

A structured education program for lung transplant patients was developed and integrated into their electronic files, improving coordination among the healthcare team and ensuring that key information was consistently provided.

After implementing the program, most patients reported feeling confident about managing their care at home, indicating potential effectiveness in enhancing patient self-management skills, although further testing is needed to confirm long-term knowledge retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a standardized, evidence-based education program using the patient's electronic file for lung transplant recipients. Schaevers, V., Schoonis, A., Frickx, G., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05135156

NCT05135156 | Lung Transplant READY Pilot Study

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). More than half of people with CF who die without a lung transplant ...

2.

pmc.ncbi.nlm.nih.gov

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

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

We engaged people with CF and CF physicians in human-centered design of “Take On Transplant” (TOT), a web-based education tool to prepare patients for LTx ...

3.

clinicaltrials.gov

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

Lung Transplant READY CF 2: A Multi-site RCT

The overall research objectives for this study are to test the efficacy of the investigator-designed educational resource to improve patient preparedness for ...

4.

kumc.trialstoday.org

kumc.trialstoday.org/list/print/NCT06030206

Lung Transplant READY CF 2: A Multi-site RCT

Based on prior research, investigators developed a novel lung transplant educational resource that addresses patient-identified knowledge gaps ...

5.

withpower.com

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

Lung Transplant Education for Cystic Fibrosis

What data supports the effectiveness of this treatment for lung transplant education in cystic fibrosis patients? Research shows that effective lung transplant ...

6.

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 ...

7.

withpower.com

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

Lung Transplant Education for Cystic Fibrosis

The research articles do not provide specific safety data for the Lung Transplant Education Website or similar educational interventions. They focus on adverse ...

8.

hopkinsmedicine.org

hopkinsmedicine.org/pulmonary/research/cystic-fibrosis/lung-transplantation

Johns Hopkins Lung Transplant Research Project List

Cohort Studies of Lung Transplant Outcomes in Cystic Fibrosis and other Diseases. This series of studies utilizes data from the United Network for Organ Sharing.