Lung Transplant READY CF 2: CARING CF Ancillary RCT

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06032273
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Investigator-designed lung transplant education website — BEHAVIORAL
    Caregiver participants assigned to the intervention will access the investigator-designed educational resource via their login to a secure website.

Study Details

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

Key Dates

Start date
Sep 6, 2023
Status verified
Dec 2024
Primary completion
Sep 30, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Access to investigator-designed lung transplant education website
    Access to an investigator-designed web-based educational resource with information about lung transplant for three months.
  • No Intervention: No access to lung transplant education website
    No access to the investigator-designed lung transplant educational resource.

Primary Outcome Measure

Brief Assessment Scale for Caregivers (BASC) [ Time Frame: Measured at the 3-month and 6-month study visits ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medical Center - MontlakeSeattleWashington98195
Lauren Bartlett, BS, CCRC
[email protected]
503-583-2869
Kathleen Ramos, MD, MSc

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University of Washington Medical Center - Montlake· Seattle, WA

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