Lung Transplant Education for Cystic Fibrosis
Recruiting in Palo Alto (17 mi)
Overseen byKathleen Ramos, MD, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Disqualifiers: Inability to consent, Language barriers
Stay on Your Current Meds
No Placebo Group
Approved in 1 Jurisdiction
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.
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
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.
12345Is 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.
678910How 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.
24111213Eligibility 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.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Washington Medical Center - MontlakeSeattle, WA
Loading ...
Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
Cystic Fibrosis FoundationCollaborator
References
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.
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.
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 = 0.23). TAQ showed no difference between the two groups (p = 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 = 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.
A Mixed Methods Assessment of Home-Based Video Pretransplant Lung Education. [2022]Introduction: Patients awaiting lung transplantation must learn new information to successfully navigate the transplant process. A supplemental video series was piloted to patients at home during the Covid-19 pandemic to improve pre-transplant education. Methods: A mixed methods study was undertaken to assess patient experiences with this method of education, confirm the ideal timing of the education, and identify gaps that require further attention. Semi-structured interviews were conducted with 17 one-on-one or dyadic (patients and caregivers) who viewed the video series at home. A third-party researcher (not involved in creation of the educational materials) conducted the interviews by phone, which were audio recorded and then transcribed verbatim. NVivo 12 Pro for Windows software was used to code the data and identify emerging themes. Results: Participants indicated that home-based videos were applicable, and informative and helpful (4.7 on 5-point Likert scale) and appreciated the advice and experiences of real patients. They were satisfied with their transplant education (4.2/5). While there were few aspects that the participants disliked about the videos, the interviews elicited outstanding questions about the transplant process (eg, logistical aspects of travel) and transplant concerns (eg, medications, expenses, and precautions in daily life). Conclusion: Patients being assessed or listed for lung transplant valued the novel electronic video education, and we will implement the home-based process into standard of care after the patient's initial visit with the transplant respirologist. Pre-transplant education will be tailored to help address the outstanding gaps identified in this program evaluation.
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.
The impact of minor adverse event tracking on subject safety: a web-based system. [2009]BASED ON THE ASSUMPTION THAT MINOR symptoms may presage serious events, we report four years' experience with a web-based adverse event (AE) tracking system (eAETS) designed to capture AEs of a minor nature that would not meet criteria for ethical review. The eAETS has supported 175 diverse clinical protocols, is user-friendly and navigationally intuitive, and restricts access based on protocol ownership. The user creates an initial risk profile for comparison to subsequent AEs to identify unanticipated patterns. Out of 2,440 AE reports, 1,053 did not match the risk profile. Corrective modification was recommended in 6 (13%) protocols. The eAETS provides a framework for weighing the impact of AEs on subject safety.
Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. [2023]Clear definition, identification, and reporting of adverse event (AE) monitoring during training interventions are essential for decision making regarding the safety of training and testing in youths.
Adverse Events Reporting Systems in Cells, Organs, and Tissues Donation and Transplantation: Scoping Review. [2023]This study aimed to map adverse events reporting systems in cells, organs, and tissues donation and transplantation, including the terms applicable in each system and scientific literature.
Evaluating the completeness and accuracy of MedWatch data. [2017]The Food and Drug Administration's MedWatch system--a voluntary surveillance program--received 600,000 adverse event reports on marketed drugs and devices in 2011. The Food and Drug Administration credits the MedWatch system with improving awareness, and expediting early detection, of drug and device risks and in illuminating the adoption of medical treatments. Reporting bias has been acknowledged as a limitation of the MedWatch system. No systematic assessment of the accuracy and completeness of adverse event reporting has been conducted, yet inaccurate adverse event reporting may lead drug safety professionals to draw incorrect conclusions, manufacturers may be wrongly forced to suspend and withdraw medications and interventions, health professionals may mistakenly alter their clinical practices, and patients may be denied safe and effective treatments. In 2011, the Tufts Center for the Study of Drug Development gathered and analyzed 10.2 million adverse event reports filed with the MedWatch system. Patient information was generally complete and accurate. Suspect product information, on the other hand, showed high levels of incomplete and inaccurate data. Start and end dates of suspect product use had 37% and 23% completion rates, respectively. Dosage level was completed only 31% of the time, and product lot numbers had only a 9% completion rate. More than 25% of the names of reported suspect products were inaccurate, and 31% of suspect product start dates were inaccurate. Higher levels of completion and accuracy were associated with reports filed closer to the date when the adverse event was observed. Implications of the results and suggested improvements are discussed.
Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors. [2020]Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of uninformative investigational new drug safety reports that sponsors submit to the US Food and Drug Administration and participating investigators, which strain resources and impede the detection of valid safety signals. To improve the quality of serious AE (SAE) reporting by physician-investigators and research staff, ASCO developed and tested a Decision Aid.
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.
Cystic fibrosis foundation: achieving the mission. [2019]The Cystic Fibrosis Foundation is a voluntary, nonprofit, health organization whose mission is "to assure the development of the means to cure and control cystic fibrosis and to improve the quality of life for those with the disease." While substantial progress has been made, as evidenced by a marked increase in the median predicted age of survival, much work remains to be done. Ongoing medical programs and activities of the Cystic Fibrosis Foundation, which span basic science, drug discovery, drug development, clinical care, patient education, and advocacy, will be described in this article. The key role of respiratory therapists in the cystic fibrosis community will be highlighted.
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.