Lung Transplant READY CF 2: CARING CF Ancillary RCT
This study is looking at how an educational website about lung transplants can help people with cystic fibrosis (CF) and their caregivers. Many people with CF who could benefit from a lung transplant don't get one, sometimes because they aren't referred or don't have enough information. This study aims to see if providing information through a website can help caregivers and people with CF understand lung transplant options better. Researchers will measure how well caregivers feel supported and how effective their social support is after using the website. You can join if you are an adult caregiver or loved one of someone with CF, or an adult with CF, who is already part of the main Lung Transplant READY CF 2 study. The study is currently unclear about its recruitment status and plans to enroll 132 participants.
- Study design
- This is an interventional study where participants are assigned to use an investigator-designed lung transplant education website. It plans to enroll 132 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months, with measurements taken at 3 and 6 months.
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Lung Transplant READY CF 2: CARING CF Ancillary RCT
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kathleen Ramos, MD, MS · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Brief Assessment Scale for Caregivers (BASC)Measured at the 3-month and 6-month study visits
The co-primary endpoint is an intention-to-treat assessment of the difference in caregivers' mean change in Brief Assessment Scale for Caregivers (BASC) in the intervention versus control arms of the study from the 3-month to the 6-month study visit using linear mixed models. The BASC is a validated 14-item measure of caregiver burden and includes subscales that reflect positive personal impact (PPI) and negative personal impact (NPI) of caregiving responsibilities. The BASC includes a 4-point Likert scale (scored 0 to 3), with higher scores indicating more burden, and the overall BASC score is an average of the 14 item scores. The BASC has high internal consistency in caregivers for adults with CF (Cronbach's alpha 0.88 for overall BASC and 0.82 for PPI).
- Social Support Effectiveness Questionnaire (SSE-Q)Measured at the 3-month and 6-month study visits
A co-primary endpoint is an intention-to-treat assessment of change in patient's Social Support Effectiveness Questionnaire (SSE-Q) from 3 months to 6 months and investigators will compare mean change between patients whose caregivers were randomized to the intervention versus control using linear mixed models. The SSE-Q is a validated 26-item measure of social support with higher scores indicating more effective support. The overall scale ranges from 0 to 80 and each subscale can range from 0 to 20. There are 4 subscales: task support, informational support, emotional support and negative effects of support. The first 15 questions are rated on a 5-point Likert scale and the last questions have yes/no responses. The SSE-Q has not previously been utilized in the CF population.