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Lung Transplant Education for Cystic Fibrosis

N/A

Recruiting

Led By Kathleen Ramos, MD, MS

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at the 3-month and 6-month study visits

Awards & highlights

Study Summary

This trial aims to understand how caregivers can better support individuals with CF considering lung transplant by providing educational resources and assessing the benefits of such support.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves using an educational website rather than a medical treatment, traditional side effects are not applicable. However, participants may experience emotional or psychological impacts from the information provided.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at the 3-month and 6-month study visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at the 3-month and 6-month study visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at the 3-month and 6-month study visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brief Assessment Scale for Caregivers (BASC)

Social Support Effectiveness Questionnaire (SSE-Q)

Secondary outcome measures

Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)

Generalized Anxiety Disorder 7-item (GAD-7) Scale

Likert-scale rating of preparedness to discuss lung transplant with their loved one (0-4)

+1 more

Other outcome measures

Assessment of Brief Assessment Scale for Caregivers (BASC): among caregivers of members of communities of concern (low socioeconomic status, Hispanic ethnicity, or Black/Asian/Other race).

Assessment of Brief Assessment Scale for Caregivers (BASC): by caregiver gender

Assessment of Social Support Effectiveness Questionnaire (SSE-Q): among members of communities of concern (low socioeconomic status, Hispanic ethnicity, or Black/Asian/Other race).

+2 more

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cystic Fibrosis FoundationOTHER

189 Previous Clinical Trials

37,078 Total Patients Enrolled

182 Trials studying Cystic Fibrosis

34,141 Patients Enrolled for Cystic Fibrosis

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,628 Total Patients Enrolled

24 Trials studying Cystic Fibrosis

45,735 Patients Enrolled for Cystic Fibrosis

Kathleen Ramos, MD, MSPrincipal InvestigatorUniversity of Washington

1 Previous Clinical Trials

52 Total Patients Enrolled

1 Trials studying Cystic Fibrosis

52 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial still available?

"Affirmative. The clinical trial, which was first posted on September 6th 2023 is currently recruiting patients according to the information found on clinicaltrials.gov. This research has a total of 132 participants and is only taking place in one medical centre."

Answered by AI

What is the upper limit of participation for this clinical trial?

"Affirmative. According to the information listed on clinicaltrials.gov, this experiment is still actively recruiting individuals as of September 10th 2023, when it was last updated; it initially posted on June 9th 2023 and calls for 132 participants at one primary location."

Answered by AI

What are the intended outcomes of this research project?

"As the primary outcome, Social Support Effectiveness Questionnaire (SSE-Q) will be assessed at 3 months and 6 months. Secondary outcomes include a Likert-scale rating of preparedness to discuss lung transplant with their loved ones, Patient Health Questionnaire (PHQ-8), and Generalized Anxiety Disorder 7-item (GAD-7) Scale that measure depression/anxiety symptoms over two weeks. An intention-to treat analysis via linear mixed models will compare mean change in scores between intervention vs control arms as well ascertain proportion who exceed thresholds for diagnosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lung Transplant READY CF 2: CARING CF Ancillary RCT

Kathleen Ramos 2023. "Lung Transplant READY CF 2: CARING CF Ancillary RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032273.

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