Trial Outcomes & Findings for Lung Transplant READY Pilot Study (NCT NCT05135156)

NCT ID: NCT05135156

Last Updated: 2023-12-29

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: Measured at 2-week study visit
• Results posted on: 2023-12-29

Participant Flow

A screening survey was advertised at 15 CF Centers in the United States who agreed to approach their adult CF patients with an FEV1 <50% predicted to share information about our study. Survey respondents could 'opt in' to being contacted about additional research opportunities related to lung transplant. We also approached CF patients at the University of Washington Adult CF Center who had an FEV1 <50% predicted. Recruitment occurred from December 2021 to November 2022.

A total of 52 participants consented. Of these, 2 were lost to follow up and 50 were randomized to study arms, 25 per arm.

Participant milestones

Measure	Intervention Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Participants who consented but were not randomized
Overall Study STARTED	25	25	2
Overall Study COMPLETED	25	25	0
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Measure	Intervention Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Participants who consented but were not randomized
Overall Study Lost to Follow-up	0	0	2

Baseline Characteristics

Lung Transplant READY Pilot Study

Baseline characteristics by cohort

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Total n=50 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	40 years n=7 Participants	37 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Community of Concern (Yes/No)	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Taking CFTR modulator	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Current FEV1 %predicted 41-50%	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Current FEV1 %predicted 30-40%	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Current FEV1 %predicted <30%	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized n=2 Participants Consented but lost to follow up prior to baseline study visit
Feasibility of Participants Completing 2-week Study Visit	25 Participants	25 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Preparedness for Shared Decision Making (PrepDM) Scale	71 score on a scale Standard Deviation 16	57 score on a scale Standard Deviation 23	—

SECONDARY outcome

Timeframe: 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 transplant.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)	11.6 score on a scale Standard Deviation 6.0	8.8 score on a scale Standard Deviation 7.4	—

SECONDARY outcome

Timeframe: 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].

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Decisional Conflict Scale	-12 score on a scale Standard Deviation 17	-11 score on a scale Standard Deviation 17	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4)	3.4 units on a scale Standard Deviation 0.7	3.1 units on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Patient Health Questionnaire (PHQ-9)	5.6 score on a scale Standard Deviation 5.2	4.8 score on a scale Standard Deviation 4.8	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Patient Health Questionnaire (PHQ-9)	0.16 proportion of participants	0.12 proportion of participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Generalized Anxiety Disorder 7-item (GAD-7) Scale	4.6 score on a scale Standard Deviation 4.1	4.3 score on a scale Standard Deviation 4.3	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Generalized Anxiety Disorder 7-item (GAD-7) Scale	0.08 proportion of participants	0.16 proportion of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale	72 score on a scale Standard Deviation 22	77 score on a scale Standard Deviation 17	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 score from baseline to 4 weeks between study arms. This compares the effect of 4-week exposure to Take on Transplant [intervention arm] vs. 2-week exposure [control arm] on improvement in knowledge scores.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)	4.4 score on a scale Standard Deviation 4.2	1.2 score on a scale Standard Deviation 4.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 Transplant [intervention arm] vs. 2-week exposure [control arm] on improvement in knowledge scores.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
4-week Assessment for Decisional Conflict Scale	-16.4 score on a scale Standard Deviation 16.4	-10.4 score on a scale Standard Deviation 21.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at baseline, 2-week and 4-week study visits

Evaluate the proportion "Very prepared" at baseline, 2 weeks and 4 weeks in the intervention and control arms. Compare proportions across study arms at each time point.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant Baseline	0.52 proportion of participants	0.40 proportion of participants	—
4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant 2 weeks	0.52 proportion of participants	0.40 proportion of participants	—
4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant 4 weeks	0.76 proportion of participants	0.60 proportion of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2-week study visit

Median time spent using the research website from baseline to 2 weeks will be compared across study arms. Further, time spent using the investigator-designed website will be assessed as a predictor of: 1. change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit, 2. change in Likert preparedness from baseline to 2-week study visit, 3. change in Decisional Conflict Scale from baseline to 2-week study visit, and 4. mean PrepDM Scale at 2-weeks.

Outcome measures

Measure	Intervention n=25 Participants Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.	Control n=25 Participants Access to a publicly available web-based educational resource with information about transplant for two weeks. Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.	Consented, Not Randomized Consented but lost to follow up prior to baseline study visit
Time Spent Using the Research Website	133 minutes Interval 88.0 to 179.0	142 minutes Interval 81.0 to 215.0	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=25 participants at risk Investigator-designed lung transplant education resource (Research Intervention)	Control n=25 participants at risk Publicly available transplant education resource (Attention Control)
Psychiatric disorders Possible suicidality endorsed on PHQ-9	8.0% 2/25 • Number of events 3 • Adverse event data were collected during Zoom study visits (baseline, 2 weeks, 4 weeks).	4.0% 1/25 • Number of events 1 • Adverse event data were collected during Zoom study visits (baseline, 2 weeks, 4 weeks).

Additional Information

Dr. Kathleen J. Ramos

University of Washington

Phone: 2065430393

Email: ramoskj@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place