NCT05135156

Lung Transplant READY Pilot Study

Completed NA Results posted Last updated 29 December 2023

What this trial tests

NA trial testing Investigator-designed lung transplant education resource (Research Intervention) in Cystic Fibrosis in 52 participants. Completed in 1 November 2022.

Timeline

6 December 2021

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	52
Start date	6 December 2021
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Investigator-designed lung transplant education resource (Research Intervention)
• Publicly available transplant education resource (Attention Control)

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Participants Completing 2-week Study Visit Primary · Measured at 2-week study visit

The co-primary endpoint is feasibility, which will be defined as successful if 90% of enrolled participants complete the 2-week study visit (regardless of study arm).

Group	Value	95% CI
Intervention	25
Control	25
Consented, Not Randomized	0

Preparedness for Shared Decision Making (PrepDM) Scale Primary · Measured at 2-week study visit

The co-primary endpoint is an intention-to-treat assessment of the difference in mean Preparedness for Shared Decision Making (PrepDM) Scale in the intervention versus control arms of the study at the 2-week study visit. Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.

Group	Value	95% CI
Intervention	71	± 16
Control	57	± 23

Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) Secondary · Measured at 2-week study visit

Difference in mean confidence-weighted true false (CTF) knowledge score will be measured in the intervention versus control arms of the study. CTF scoring adds points for certainty in correct responses and deducts points for certainty in incorrect responses. Participants receive +2 points when "sure" about a correct response, +1 if unsure about a correct response, -1 if unsure about an incorrect response and -2 if sure about an incorrect response. For a 14-item knowledge test, the maximum score is +28 and the minimum score is -28, with higher scores indicating more knowledge about lung transpl

Group	Value	95% CI
Intervention	11.6	± 6.0
Control	8.8	± 7.4

Decisional Conflict Scale Secondary · Baseline to 2-week study visit

Decisional Conflict Scale change will be measured from the baseline study visit to the 2-week study visit. The intention-to-treat analysis will compare mean change in the Decisional Conflict Scale between the intervention and control arms of the study. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].

Group	Value	95% CI
Intervention	-12	± 17
Control	-11	± 17

Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4) Secondary · Measured at 2-week study visit

Likert rating of preparedness will be measured at the 2-week study visit (0=Don't know, 1= Not at all prepared, 2 = A little prepared, 3 = Moderately prepared, 4 = Very prepared). The intention-to-treat analysis will compare mean Likert-scale rating between the intervention and control arms of the study.

Group	Value	95% CI
Intervention	3.4	± 0.7
Control	3.1	± 0.9

Patient Health Questionnaire (PHQ-9) Secondary · Measured at 2-week study visit

PHQ-9 is a scale that measures symptoms of depression in the prior 2 weeks on a 0-27 scale, with higher scores indicating worsening depression and a score of 10 or higher consistent with a diagnosis of depression. Investigators will assess the difference in mean PHQ-9 score in the intervention versus control arms of the study at the 2-week study visit.

Group	Value	95% CI
Intervention	5.6	± 5.2
Control	4.8	± 4.8

Patient Health Questionnaire (PHQ-9) Secondary · Measured at 2-week study visit

PHQ-9 is a scale that measures symptoms of depression in the prior 2 weeks on a 0-27 scale, with higher scores indicating worsening depression and a score of 10 or higher consistent with a diagnosis of depression. Investigators will determine the proportion with new PHQ-9 score greater than or equal to 10 in each arm.

Group	Value	95% CI
Intervention	0.16
Control	0.12

Generalized Anxiety Disorder 7-item (GAD-7) Scale Secondary · Measured at 2-week study visit

GAD-7 is a scale that measures symptoms of anxiety in the prior 2 weeks on a 0-21 scale, with higher scores indicating worsening anxiety and a score of 10 or higher consistent with a diagnosis of generalized anxiety disorder. Investigators will assess the difference in mean GAD-7 score in the intervention versus control arms of the study at the 2-week study visit.

Group	Value	95% CI
Intervention	4.6	± 4.1
Control	4.3	± 4.3

Generalized Anxiety Disorder 7-item (GAD-7) Scale Secondary · Measured at 2-week study visit

GAD-7 is a scale that measures symptoms of anxiety in the prior 2 weeks on a 0-21 scale, with higher scores indicating worsening anxiety and a score of 10 or higher consistent with a diagnosis of generalized anxiety disorder. Investigators will determine the proportion with new GAD-7 score greater than or equal to 10 in each arm.

Group	Value	95% CI
Intervention	0.08
Control	0.16

4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale Secondary · Measured at 4-week study visit

The PrepDM Scale will be measured for all participants with respect to the investigator-designed educational resource (research intervention) and mean score will be compared for participants in the intervention (4 weeks of exposure) versus control arms (2 weeks of exposure). PrepDM scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.

Group	Value	95% CI
Intervention	72	± 22
Control	77	± 17

4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) Secondary · Measured at Baseline, 2-week study visit, 4-week study visit

Change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey with minimum possible score -28 and maximum possible score 28; higher scores indicate more knowledge about lung transplant) will be assessed from immediately prior to intervention exposure to the end of exposure time. For participants in the intervention arm, this represents change from baseline to 4-weeks. For participants in the Attention Control arm, this represents change from 2-week to 4-week study visits. The statistical analysis will compare mean change in the knowledge sco

Group	Value	95% CI
Intervention	4.4	± 4.2
Control	1.2	± 4.2

4-week Assessment for Decisional Conflict Scale Secondary · Measured at Baseline, 2-week study visit, 4-week study visit

Change in Decisional Conflict Scale (scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]) will be assessed from immediately prior to intervention exposure to the end of exposure time. For participants in the intervention arm, this represents change from baseline to 4-weeks. For participants in the Attention Control arm, this represents change from 2-week to 4-week study visits. The statistical analysis will compare mean change in Decisional Conflict Scale from baseline to 4 weeks between study arms. This compares the effect of 4-week exposure to Take on

Group	Value	95% CI
Intervention	-16.4	± 16.4
Control	-10.4	± 21.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected during Zoom study visits (baseline, 2 weeks, 4 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 0/25 (0%)

Deaths: 0/25

Control

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention	Control
Possible suicidality endorsed on PHQ-9	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT05135156 adverse events section.

Sponsor's own description

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). 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. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant.

The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with CF patients once their forced expiratory volume in one second (FEV1) is \<50% predicted. Considering lung transplant as a treatment option ahead of when it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist.

Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant.

Study involvement will span 4 weeks and study procedures will involve the following:

* Three Zoom interview sessions (30-60 minutes each)
* Survey assessments
* Access to a research website that contains educational resources about lung transplant (goal of 4 hours of use over the 4 week study period)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Decision aids for people facing health treatment or screening decisions.
   Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6