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EASE for Organ Transplant Recipients
N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants consented post-transplant: Incident kidney, kidney-pancreas, liver, lung, or heart transplant recipients identified during index transplant hospital admission at the inpatient transplant unit of the Ajmera Transplant Centre at Toronto General Hospital
Be older than 18 years old
Must not have
Patients in ICU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 20 (20 weeks)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to help organ transplant recipients manage physical and emotional symptoms through the Emotion And Symptom-focused Engagement (EASE) intervention. EASE involves counseling sessions and regular assessments to address mental health
Who is the study for?
The EASE-SOT Pilot Study is for organ transplant recipients experiencing physical and emotional symptoms post-transplant. It aims to help those who struggle with anxiety, fatigue, sleep issues, and pain after receiving a kidney, liver, pancreas, heart or lung transplant.
What is being tested?
This study tests the Emotion And Symptom-focused Engagement (EASE) intervention adapted for transplant patients. It includes psychological support through counseling sessions and physical symptom assessments using questionnaires to improve overall care.
What are the potential side effects?
Since EASE-SOT primarily involves counseling and symptom assessment rather than medication or invasive procedures, side effects are minimal but may include discomfort from discussing personal experiences or emotions during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I consented to participate after receiving a transplant of kidney, liver, lung, heart, or kidney-pancreas at Ajmera Transplant Centre.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently in the Intensive Care Unit (ICU).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 20 (20 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 20 (20 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence Rate
Clinical Team Acceptability
Consent Rate
+4 moreSecondary study objectives
Incidence Rate of Healthcare Use
Post-transplant Quality of Life using PROMIS physical and mental health summary scores
Post-transplant Quality of Life using the EQ-5D-5L
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EASE-SOT Intervention ArmExperimental Treatment1 Intervention
Participants in the intervention group receive EASE plus usual care. Each participant will participate in 8 EASE-psy sessions, starting twice a week during the inpatient stay and once every 1-2 weeks thereafter. They will also be screened for physical symptoms using electronic patient-reported outcome measures (ePROMs) twice a week while in-patient and once a week during the rest of the 8-week intervention period (EASE-phys). Participants will receive an output report that provides graphic representation of their current and previous scores on the various domains of health (e.g., depression, fatigue, etc.). If scoring above threshold for any symptom assessed during routine screening, participants will be referred/re-referred to a "symptom control" team. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.
Group II: Control ArmActive Control1 Intervention
Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,526 Previous Clinical Trials
503,126 Total Patients Enrolled