Lung Transplant Education for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by Kathleen Ramos, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Disqualifiers: Lung transplant recipients, others

No Placebo Group

Trial Summary

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

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}

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.

Trial 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 (Behavioral Intervention)
• Publicly available transplant education resource (Behavioral Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University Baltimore, MD

Baylor College of Medicine Houston, TX

University of California at Los Angeles (UCLA) Los Angeles, CA

Yale University New Haven, CT

More Trial Locations

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1858

Patients Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Patients Recruited

10,400,000+

References

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

Lung transplant or bust: patients' recommendations for ideal lung transplant education. [2014] Effective lung transplant education helps ensure informed decision making by patients and better transplant outcomes.

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

Identifying the educational needs of lung transplant recipients with cystic fibrosis. [2015] To elucidate the education needs of patients who have undergone lung transplant for cystic fibrosis while participating in the development of therapeutic education programs in French transplant centers.

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

An E-Learning Program Improves Patients' Knowledge After Lung Transplantation. [2021] Background: Adherence to immunosuppressive medicine in lung transplant recipients is associated with improved long-term survival. Patient education and support from health care providers are key components. We investigated e-learning as a tool to improve lung transplant recipients' knowledge of post-transplant care such as hygiene, self-monitoring, travel precautions, vaccinations, and the importance of adherence to medication. Objective: To compare the effect of e-learning and conventional patient education with respect to level of knowledge and drug adherence. A single-center open randomized controlled trial design was used. Methods: Lung transplant recipients were randomized to an e-learning program or standard care. One month before a scheduled follow-up visit, the intervention group received a link by e-mail to a 15-min e-learning program. At the follow-up visit, all lung transplant recipients completed two drug adherence questionnaires (Basel Assessment of Adherence with Immunosuppressive medication Scales [BAASIS] and Transplant Adherence Questionnaire [TAQ]) and a questionnaire testing their knowledge of post-transplant care. Results: Fifty lung transplant recipients were randomized with 24 recipients in each group completing the study. Recipient adherence measured by BAASIS showed a tendency toward improved drug adherence in the intervention group compared with the control group (71% vs. 55%, p&#8201;=&#8201;0.23). TAQ showed no difference between the two groups (p&#8201;=&#8201;1.0). Recipients in the intervention group had a significantly higher number of correct answers to questions about transplant-friendly lifestyle (median 11 vs. 10, p&#8201;=&#8201;0.02). Conclusion: A 15-min e-learning program is a simple and effective tool to improve lung transplant recipients' knowledge of post-transplant care.

4. Denmark pubmed.ncbi.nlm.nih.gov

A scoping review of pediatric transplant education. [2023] Education is crucial for pediatric patients and caregivers throughout the transplant continuum, yet data are lacking around which interventions are effective and in what circumstances.

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] Patient education is crucial to guarantee that transplant recipients are capable of adequate self-management. Until recently, our education program to prepare lung transplant patients for discharge lacked a systematic approach, meaning that it was unclear whether all key information had been provided and whether the patient understood the information. A lack of coordination among the multidisciplinary team members also was apparent.

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] In 2008 the Cystic Fibrosis (CF) Foundation launched the Respiratory Therapy Mentoring Program, which pairs a respiratory therapist (RT) relatively new to CF (apprentice) with a highly experienced RT (mentor) from a similar CF care center. We wished to determine if we had achieved our short-term goal of increasing CF-specific knowledge among the apprentices who participated in the program.

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

What do patients know? Education from the European Lung Foundation perspective. [2022] The European Lung Foundation (ELF) is an organisation whose mission is to bring together the public and patients with respiratory professionals to improve lung health. A core part of all its activities focus on education: the education of patients on their condition, including how to prevent, treat and manage it; the education of healthcare professionals on how to improve work with patients and awareness about the issues that are important to patients; and education of the public and policy makers of the importance of lung health at a European level. ELF was founded and works in a unique partnership with the European Respiratory Society (ERS). This article has been written by the recent past Chairs and the new Chairs of three ELF committees (Council (D. Smyth and I. Saraiva), Professional Advisory Committee (K. Lisspers and G. Hardavella) and Patient Advisory Committee (J. Fuertes and K. Hill)) in order to reflect on ELF's journey in this regard over recent years. In particular, it seems a good moment to assess the success and impact of the first patient Chair of ELF, Dan Smyth, and reflect on what this has meant for ELF's educational activities, and what the future now looks like.

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

Education-related needs for children with cystic fibrosis: Perspectives of US pediatric care teams. [2023] Patients with cystic fibrosis (CF) often bring education-related concerns to their medical teams. Concerns around the ability for CF care teams to identify and address these concerns exist. We sought to describe CF care team perceptions of (1) patient and family education-related needs, (2) how these needs are identified, documented and addressed, and (3) education-related resource gaps.