132 Participants Needed

Lung Transplant Education for Cystic Fibrosis

LB
Overseen ByLauren Bartlett, BS, CCRC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.678910

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.24111213

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

Research Team

KR

Kathleen Ramos, MD, MS

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Access to investigator-designed lung transplant education websiteExperimental Treatment1 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 websiteActive Control1 Intervention
No access to the investigator-designed lung transplant educational resource.

Find a Clinic Near You

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+

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

References

Lung transplant or bust: patients' recommendations for ideal lung transplant education. [2014]
Identifying the educational needs of lung transplant recipients with cystic fibrosis. [2015]
An E-Learning Program Improves Patients' Knowledge After Lung Transplantation. [2021]
A Mixed Methods Assessment of Home-Based Video Pretransplant Lung Education. [2022]
A scoping review of pediatric transplant education. [2023]
The impact of minor adverse event tracking on subject safety: a web-based system. [2009]
Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. [2023]
Adverse Events Reporting Systems in Cells, Organs, and Tissues Donation and Transplantation: Scoping Review. [2023]
Evaluating the completeness and accuracy of MedWatch data. [2017]
10.United Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
A preliminary evaluation of the effectiveness of the Cystic Fibrosis Foundation Mentoring Program for Respiratory Care. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Cystic fibrosis foundation: achieving the mission. [2019]
What do patients know? Education from the European Lung Foundation perspective. [2022]
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