Lung Transplant Education for Cystic Fibrosis

Recruiting in Cincinnati (<99 mi)

+10 other 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

Trial Summary

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 data supports the effectiveness of this treatment for lung transplant education in cystic fibrosis patients?

Research shows that effective lung transplant education helps patients make informed decisions and leads to better transplant outcomes. Additionally, an e-learning program improved patients' knowledge about post-transplant care, suggesting that structured educational resources can enhance understanding and adherence to necessary care practices. ^{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 lung transplants specifically for cystic fibrosis, helping them make informed decisions and potentially improving transplant outcomes, rather than being a direct medical intervention. ^{1 2 6 7 8}

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. Rates of death without transplant are higher for people with CF who are members of marginalized communities, including those with Black race, Hispanic ethnicity, or low socioeconomic status. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant. The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second (FEV1) is \<50% predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant ("communities of concern"). Study involvement will span 6 months and study activities will involve the following: * Four Zoom research sessions (15-30 minutes each) * Survey assessments * Access to a research website that contains educational resources about lung transplant * Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and his/her/their CF doctor

Research Team

Kathleen Ramos, MD, MSc

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

References

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. Denmark pubmed.ncbi.nlm.nih.gov

A scoping review of pediatric transplant education. [2023]

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

Implementing a standardized, evidence-based education program using the patient's electronic file for lung transplant recipients. [2019]

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

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

7. England pubmed.ncbi.nlm.nih.gov

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

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

Education-related needs for children with cystic fibrosis: Perspectives of US pediatric care teams. [2023]