Transplant;Failure,KidneyNCT06396702

EASE-SOT Pilot Study

A study testing EASE-SOT in people with Transplant;Failure,Kidney and Transplant; Failure, Heart, run by University Health Network, Toronto at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Transplant;Failure,Kidney, Transplant; Failure, Heart, Transplant; Failure, Liver
What is being tested?: EASE-SOT
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteCanada
Study dates: May 2024to Aug 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants consented pre-transplant: Potential transplant recipients who are listed on the waitlist and are identified by pre-transplant staff, recipients who have a living donor arranged (pertaining to kidney and liver recipients), participants currently completely pre-transplant prehabilitation (pertaining to lung and heart recipients), or those who are on the top of their respective organ transplant waitlists.
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

Who cannot join

Patients in ICU.
Patients who are clinically unstable, have delirium or other severe mental health concern requiring psychiatric treatment - assessed by clinical team.
Non-English speaking patients.
Severe cognitive impairment as assessed by the recruitment and/or research team. This will be determined through communication with the organ transplant teams and by checking the patient's medical charts. If no cognitive impairment is indicated by the patients organ transplant team or is documented in their medical chart, the patient will be assessed to have no cognitive impairment.
Unwilling or unable to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Istvan Mucsi contact

4166596756

istvan.mucsi@utoronto.ca

Ana M Samudio contact

4163404800 ext. 2032

ana.samudio@uhn.ca

Canada1 site

Toronto General Hospital
Toronto, Ontario, M5G2C4
Ana M Samudio, +1 4163404800 ext. 2032, ana.samudio@uhn.ca
Heather Ford, +1 4163404800 ext. 6582, heather.ford@uhn.ca

Other trials in Canada

About this study

Official title: Emotion And Symptom-focused Engagement (EASE) Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study

Many transplant recipients may experience physical and emotional symptoms, such as anxiety, fatigue, sleep problems, pain, etc. Often, these symptoms are not reported or managed well, and can affect a patient's quality-of-life. Transplant recipients are grateful for the "gift of life" but physical and emotional symptoms reduce their quality-of-life. Transplant recipients and caregivers have felt unprepared for the ongoing symptoms and reduced quality-of-life post-transplant.

One way of monitoring and managing these symptoms is using the Emotion And Symptom-focused Engagement (EASE) intervention. EASE was originally developed for patients with acute leukemia and has begun to be adapted to help monitor and manage physical and emotional symptoms for organ transplant recipients.

EASE is comprised of two components:

Psychological - 8 supportive counselling sessions delivered by mental health clinicians to address concerns about mental health, losses from organ failure, coping with a transplant, experiences with living on the brink of death for a prolonged period of time, etc.
Physical - Regular assessments of physical symptoms using questionnaires and referral to healthcare professionals for symptom management as necessary.

EASE uses questionnaires, also called patient reported outcome measures (PROMs), for symptom assessment and monitoring. PROMs measure symptom severity, similarly to how bloodwork measures organ functioning. PROMs, as part of EASE, will ask recipients questions and help identify relevant physical, emotional, and social symptoms to enhance their care.

With the help of specialists, patients, and support from the Kidney Foundation of Canada, our team has begun to adapt the EASE intervention for transplant recipients. In order to finalize the adaptation of the EASE intervention for use in a routine transplant clinic, we are launching a pre-pilot study to gain real-life experience from managing symptoms of SOT recipients with the use of EASE-SOT.

Read the detailed description

This is a parallel arm, randomized, controlled pilot study that will assess the feasibility for a large effectiveness trial using the EASE intervention to screen and manage emotional distress and physical symptoms among solid organ transplant (SOT) recipients. We will use a sequential cluster organization for recruitment. Initially, we will recruit kidney and kidney-pancreas transplant recipients, since we already have funding for this portion of our work. Subsequently, we will complete our study plan by recruiting liver, lung, and heart transplant recipients.

EASE integrates supportive counseling and trauma-focused cognitive behavioral therapy (CBT) (EASE-psy) with systematic physical symptom screening and triggered referral to supportive care to manage moderate to severe physical symptoms (EASE-phys). 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 week 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).

Based on individual preference, participants will receive these ePROMs either on tablets or their personal electronic devices via email, while in the hospital ward or in clinics, ensuring easy access and administration of these tools. 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.). This report will contain customized embedded URL links to the Symptomcare public domain. Embedded links will be in the form of: https://symptomcare.org/managing-my-symptoms-overview-patient/depression/?subjectid=1234\&token=abcd. If scoring above threshold for any symptom assessed during routine screening, participants will be referred/re-referred to a "symptom control" team. Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8 12 and 20 weeks by patients in both arms.

Conditions: Transplant;Failure,Kidney, Transplant; Failure, Heart, Transplant; Failure, Liver, Transplant; Failure, Pancreas, Transplant; Failure, Lung(S)
Being tested: EASE-SOT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EASE-SOTOther
EASE integrates supportive counseling and trauma-focused cognitive behavioral therapy (CBT) (EASE-psy) with systematic physical symptom screening and triggered referral to supportive care to manage moderate to severe physical symptoms (EASE-phys) using electronic patient reported outcome measures (ePROMs). The intervention duration is 8 weeks. Based on individual preference, EASE-psy may be administered in person or virtually via Microsoft Teams. Based on individual preference, participants may receive ePROMs either on tablets or to their personal electronic devices via email, while at the hospital ward and in clinics, ensuring easy access and administration of these tools.

Study groups in NCT06396702
Study group	Role	What they receive
EASE-SOT Intervention Arm	Experimental	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. Receives: Other: EASE-SOT
Control Arm	No intervention	Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment Target
Feasibility of the EASE-SOT intervention will be confirmed if our recruitment target of 120 participants (40 kidney and kidney-pancreas transplant recipients and 80 liver, lung, and heart transplant recipients) in a 30 month recruitment period is met.
Measured: Baseline
Consent Rate
The consent rate describes the proportion of eligible patients who decline consent. Feasibility of the EASE-SOT intervention will be confirmed if the decline rate is ≤50%.
Measured: Baseline
Retention Rate
The proportion of enrolled participants who continue to participate in the study at 8 weeks post-enrollment. Feasibility will be confirmed by a retention rate of 70%.
Measured: Baseline to week 8 (8 weeks)
Adherence Rate
The proportion of enrolled participants who complete the EASE-Psy sessions, the symptom screening (EASE-phys) and outcome measures at the time offered, and have meetings the supportive care team if indicated by screens. Feasibility will be confirmed if ≥50% of participants complete EASE-psy sessions and symptom screening (EASE-phys) and outcome measures ≥50% of the time offered and have ≥1 meeting with the supportive care team if indicated by screens.
Measured: Baseline to week 20 (20 weeks)
Drop-out Rate
The drop-out rate describes the proportion of enrolled participants who drop-out of the study for any reason (modality change, death, withdrawal, or loss to follow-up, etc.). Reasons for drop-out will be documented to assess the feasibility of the EASE-SOT intervention.
Measured: Baseline to week 20 (20 weeks)
Patient Acceptability
Proportion of patients who find the EASE-SOT intervention 1) acceptable, 2) not burdensome, and 3) important based on responses to the "Patient Satisfaction Survey". Acceptability will be confirmed if >80% of patients find EASE acceptable.
Measured: Baseline to week 20 (20 weeks)
Clinical Team Acceptability
Proportion of staff who find the EASE-SOT intervention intrusive to workflow, based on responses to the "Staff Satisfaction Survey". Acceptability will be confirmed if <20% of staff find the process intrusive to workflow.
Measured: Baseline to week 20 (20 weeks)

Secondary outcomes (6)

Incidence Rate of Healthcare Use
11-item recent healthcare use questions regarding healthcare use events such as recent hospitalizations, emergency visits, healthcare use. Incidence rates (event/100 patient years) of hospitalization, emergency admission, and hospitalization. Incidence rates will be compared between the two groups.
Measured: Baseline to week 20 (20 weeks)
Post-transplant Quality of Life using the EQ-5D-5L
Measured by the the EuroQol-5 Dimension-5 Level (EQ5D5L) and Patient Reported Outcomes Measurement Information System (PROMIS) physical and mental health summary scores. The EQ5D5L measures quality of life (QOL) and utilities of health states by assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a single item for each domain, measured on five response levels. We will use the Canadian value set. The PROMIS physical and mental health summary scores are calculated using responses to the domain specific item banks included in the PROMIS 29+2 v2.1 Profile measure.
Measured: Baseline to week 20 (20 weeks)
Post-transplant Quality of Life using PROMIS physical and mental health summary scores
The Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v1.2 profile assesses pain intensity using a single 0-10 numeric rating item, cognitive function using 2 items, and seven additional domains of health (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance). The seven additional domains of health will be assessed using computer adaptive testing (CAT). The PROMIS 29 scales are scored on a T-score metric with a mean score of 50 and standard deviation of 10. For symptom domains, a higher score indicates a higher severity of that symptom. For function domains, a higher score indicates less impairment. The PROMIS physical and mental health summary scores are calculated using responses to the domain specific item banks included in the PROMIS 29+2 v2.1 Profile measure.
Measured: Baseline to week 20 (20 weeks)
Presence of post-traumatic stress symptoms post-transplant using the SASRQ
Measured by the Stanford Acute Stress Reaction Questionnaire (SASRQ). The SASRQ is a 30-item questionnaire used to measure traumatic stress symptoms, including anxiety and dissociation symptoms, using a valid and reliable scale. The instructions were modified to refer to organ failure and the transplant surgery as the "traumatic event".
Measured: Baseline to week 20 (20 weeks)
Presence of post-traumatic stress symptoms post-transplant using the PCL-5
Measured by the Post-traumatic stress disorder checklist (PCL-5). The PCL-5 is a 20-item questionnaire used to measure traumatic stress using a valid and reliable scale. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the Diagnostic and Statistical Manual - IV (DSM-IV).
Measured: Baseline to week 20 (20 weeks)
Severity of physical and emotional symptoms post-transplant
Measured by Patient Reported Outcomes Measurement Information System item banks administered using Computer Adaptive Testing (CAT) for anxiety, depression, dyspnea severity, fatigue, sleep disturbance, pain interference, pain intensity, physical function, cognitive function, and ability to participate in social roles and activities. For each domain specific item bank, responses to individual items are summed and converted into a standardized T-score, normalized to the US general population with a mean score of 50 and standard deviation of 10. For symptom domains, a higher score indicates a higher severity of that symptom. For function domains, a higher score indicates less impairment. When administered as CATs, 4 or more items are administered until standard error of measurement (SEM) is 0.30 or lower (equivalent to a reliability of 0.9 or higher) or 6 items have been asked. The recommended cut-off score for moderate-severe anxiety and depression symptoms on PROMIS tools is ≥60.
Measured: Baseline to week 20 (20 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2024Aug 2027

First posted2 May 2024
Study startMay 2024 (estimated)
Primary completionAug 2027 (estimated)
Study completionAug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (108)Papers the sponsor has linked to this study.
Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06396702
Sponsor's protocol ID: 22-6002
Status last verified: Apr 2024
First submitted: 25 Apr 2024
Last updated: 2 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Costanzo MR, Mills RM, Wynne J. Characteristics of "Stage D" heart failure: insights from the Acute Decompensated Heart Failure National Registry Longitudinal Module (ADHERE LM). Am Heart J. 2008 Feb;155(2):339-47. doi: 10.1016/j.ahj.2007.10.020. Epub 2007 Dec 19.
PubMed 18215606
Ko DT, Alter DA, Austin PC, You JJ, Lee DS, Qiu F, Stukel TA, Tu JV. Life expectancy after an index hospitalization for patients with heart failure: a population-based study. Am Heart J. 2008 Feb;155(2):324-31. doi: 10.1016/j.ahj.2007.08.036.
PubMed 18215604
Canadian Institute for Health Information, Canadian Organ Replacement Register annual report: treatment of end-stage organ failure in Canada, 2004 to 2013. 2015, Canadian Institute for Health Information: Ottawa, Ontario.
Zelmer JL. The economic burden of end-stage renal disease in Canada. Kidney Int. 2007 Nov;72(9):1122-9. doi: 10.1038/sj.ki.5002459. Epub 2007 Aug 15.
PubMed 17700643
ECONOMIC BURDEN OF ILLNESS IN CANADA, 2005-2008. 2017, Public Health Agency of Canada.
Kidney Foundation of Canada, Facing the facts: includes highlights from the Canadian Organ Replacement Register. 2015.
Klarenbach SW, Tonelli M, Chui B, Manns BJ. Economic evaluation of dialysis therapies. Nat Rev Nephrol. 2014 Nov;10(11):644-52. doi: 10.1038/nrneph.2014.145. Epub 2014 Aug 26.
PubMed 25157840
Joshi VD. Quality of life in end stage renal disease patients. World J Nephrol. 2014 Nov 6;3(4):308-16. doi: 10.5527/wjn.v3.i4.308.
PubMed 25374827
Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
PubMed 21883901
Molnar-Varga M, Molnar MZ, Szeifert L, Kovacs AZ, Kelemen A, Becze A, Laszlo G, Szentkiralyi A, Czira ME, Mucsi I, Novak M. Health-related quality of life and clinical outcomes in kidney transplant recipients. Am J Kidney Dis. 2011 Sep;58(3):444-52. doi: 10.1053/j.ajkd.2011.03.028. Epub 2011 Jun 12.
PubMed 21658828
Kovacs AZ, Molnar MZ, Szeifert L, Ambrus C, Molnar-Varga M, Szentkiralyi A, Mucsi I, Novak M. Sleep disorders, depressive symptoms and health-related quality of life--a cross-sectional comparison between kidney transplant recipients and waitlisted patients on maintenance dialysis. Nephrol Dial Transplant. 2011 Mar;26(3):1058-65. doi: 10.1093/ndt/gfq476. Epub 2010 Aug 4.
PubMed 20685829
CIHI, Annual Statistics on Organ Replacement in Canada: Dialysis, Transplantation and Donation, 2010 to 2019. 2020, Canadian Institute for Health Information: Ottawa, Ontario, Canada.
Bryant RA, Creamer M, O'Donnell M, Silove D, McFarlane AC. The capacity of acute stress disorder to predict posttraumatic psychiatric disorders. J Psychiatr Res. 2012 Feb;46(2):168-73. doi: 10.1016/j.jpsychires.2011.10.007. Epub 2011 Nov 14.
PubMed 22088925
Rosson S, Monaco F, Miola A, Cascino G, Stubbs B, Correll CU, Firth J, Ermis C, Perrotti A, Marciello F, Carvalho AF, Brunoni AR, Fusar-Poli P, Fornaro M, Gentile G, Granziol U, Pigato G, Favaro A, Solmi M. Longitudinal Course of Depressive, Anxiety, and Posttraumatic Stress Disorder Symptoms After Heart Surgery: A Meta-Analysis of 94 Studies. Psychosom Med. 2021 Jan 1;83(1):85-93. doi: 10.1097/PSY.0000000000000872.
PubMed 33021524
Rodin G, Yuen D, Mischitelle A, Minden MD, Brandwein J, Schimmer A, Marmar C, Gagliese L, Lo C, Rydall A, Zimmermann C. Traumatic stress in acute leukemia. Psychooncology. 2013 Feb;22(2):299-307. doi: 10.1002/pon.2092. Epub 2011 Nov 13.
PubMed 22081505

Interested in taking part?

Istvan Mucsi

4166596756

istvan.mucsi@utoronto.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Emotion And Symptom-focused Engagement (EASE) Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study
ClinicalTrials.gov ID: NCT06396702
Acronym / sponsor ID: 22-6002
Conditions: Transplant;Failure,Kidney, Transplant; Failure, Heart, Transplant; Failure, Liver, Transplant; Failure, Pancreas, Transplant; Failure, Lung(S)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Study start: May 2024 (estimated)
Primary completion: Aug 2027 (estimated)
Study completion: Aug 2027 (estimated)
First posted: 2 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

EASE is comprised of two components:

Psychological - 8 supportive counselling sessions delivered by mental health clinicians to address concerns about mental health, losses from organ failure, coping with a transplant, experiences with living on the brink of death for a prolonged period of time, etc.
Physical - Regular assessments of physical symptoms using questionnaires and referral to healthcare professionals for symptom management as necessary.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
EASE-SOT Intervention Arm	Experimental	Other: EASE-SOTParticipants 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.
Control Arm	No intervention	–Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants consented pre-transplant: Potential transplant recipients who are listed on the waitlist and are identified by pre-transplant staff, recipients who have a living donor arranged (pertaining to kidney and liver recipients), participants currently completely pre-transplant prehabilitation (pertaining to lung and heart recipients), or those who are on the top of their respective organ transplant waitlists.
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

Key exclusion criteria (5 listed)

Patients in ICU.
Patients who are clinically unstable, have delirium or other severe mental health concern requiring psychiatric treatment - assessed by clinical team.
Non-English speaking patients.
Severe cognitive impairment as assessed by the recruitment and/or research team. This will be determined through communication with the organ transplant teams and by checking the patient's medical charts. If no cognitive impairment is indicated by the patients organ transplant team or is documented in their medical chart, the patient will be assessed to have no cognitive impairment.
Unwilling or unable to provide informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EASE-SOTEASE integrates supportive counseling and trauma-focused cognitive behavioral therapy (CBT) (EASE-psy) with systematic physical symptom screening and triggered referral to supportive care to manage moderate to severe physical symptoms (EASE-phys) using electronic patient reported outcome measures (ePROMs). The intervention duration is 8 weeks. Based on individual preference, EASE-psy may be administered in person or virtually via Microsoft Teams. Based on individual preference, participants may receive ePROMs either on tablets or to their personal electronic devices via email, while at the hospital ward and in clinics, ensuring easy access and administration of these tools.	Other	EASE-SOT Intervention Arm

Primary outcome

Recruitment Target
Time frame: Baseline
Feasibility of the EASE-SOT intervention will be confirmed if our recruitment target of 120 participants (40 kidney and kidney-pancreas transplant recipients and 80 liver, lung, and heart transplant recipients) in a 30 month recruitment period is met.
Consent Rate
Time frame: Baseline
The consent rate describes the proportion of eligible patients who decline consent. Feasibility of the EASE-SOT intervention will be confirmed if the decline rate is ≤50%.
Retention Rate
Time frame: Baseline to week 8 (8 weeks)
The proportion of enrolled participants who continue to participate in the study at 8 weeks post-enrollment. Feasibility will be confirmed by a retention rate of 70%.
Adherence Rate
Time frame: Baseline to week 20 (20 weeks)
The proportion of enrolled participants who complete the EASE-Psy sessions, the symptom screening (EASE-phys) and outcome measures at the time offered, and have meetings the supportive care team if indicated by screens. Feasibility will be confirmed if ≥50% of participants complete EASE-psy sessions and symptom screening (EASE-phys) and outcome measures ≥50% of the time offered and have ≥1 meeting with the supportive care team if indicated by screens.
Drop-out Rate
Time frame: Baseline to week 20 (20 weeks)
The drop-out rate describes the proportion of enrolled participants who drop-out of the study for any reason (modality change, death, withdrawal, or loss to follow-up, etc.). Reasons for drop-out will be documented to assess the feasibility of the EASE-SOT intervention.
Patient Acceptability
Time frame: Baseline to week 20 (20 weeks)
Proportion of patients who find the EASE-SOT intervention 1) acceptable, 2) not burdensome, and 3) important based on responses to the "Patient Satisfaction Survey". Acceptability will be confirmed if >80% of patients find EASE acceptable.
Clinical Team Acceptability
Time frame: Baseline to week 20 (20 weeks)
Proportion of staff who find the EASE-SOT intervention intrusive to workflow, based on responses to the "Staff Satisfaction Survey". Acceptability will be confirmed if <20% of staff find the process intrusive to workflow.

6 secondary outcomes

Incidence Rate of Healthcare Use
Time frame: Baseline to week 20 (20 weeks)
Post-transplant Quality of Life using the EQ-5D-5L
Time frame: Baseline to week 20 (20 weeks)
Post-transplant Quality of Life using PROMIS physical and mental health summary scores
Time frame: Baseline to week 20 (20 weeks)
Presence of post-traumatic stress symptoms post-transplant using the SASRQ
Time frame: Baseline to week 20 (20 weeks)
Presence of post-traumatic stress symptoms post-transplant using the PCL-5
Time frame: Baseline to week 20 (20 weeks)
Severity of physical and emotional symptoms post-transplant
Time frame: Baseline to week 20 (20 weeks)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Background: PubMed 18215606Costanzo MR, Mills RM, Wynne J. Characteristics of "Stage D" heart failure: insights from the Acute Decompensated Heart Failure National Registry Longitudinal Module (ADHERE LM). Am Heart J. 2008 Feb;155(2):339-47. doi: 10.1016/j.ahj.2007.10.020. Epub 2007 Dec 19.
Background: PubMed 18215604Ko DT, Alter DA, Austin PC, You JJ, Lee DS, Qiu F, Stukel TA, Tu JV. Life expectancy after an index hospitalization for patients with heart failure: a population-based study. Am Heart J. 2008 Feb;155(2):324-31. doi: 10.1016/j.ahj.2007.08.036.
BackgroundCanadian Institute for Health Information, Canadian Organ Replacement Register annual report: treatment of end-stage organ failure in Canada, 2004 to 2013. 2015, Canadian Institute for Health Information: Ottawa, Ontario.
Background: PubMed 17700643Zelmer JL. The economic burden of end-stage renal disease in Canada. Kidney Int. 2007 Nov;72(9):1122-9. doi: 10.1038/sj.ki.5002459. Epub 2007 Aug 15.
BackgroundECONOMIC BURDEN OF ILLNESS IN CANADA, 2005-2008. 2017, Public Health Agency of Canada.
BackgroundKidney Foundation of Canada, Facing the facts: includes highlights from the Canadian Organ Replacement Register. 2015.
Background: PubMed 25157840Klarenbach SW, Tonelli M, Chui B, Manns BJ. Economic evaluation of dialysis therapies. Nat Rev Nephrol. 2014 Nov;10(11):644-52. doi: 10.1038/nrneph.2014.145. Epub 2014 Aug 26.
Background: PubMed 25374827Joshi VD. Quality of life in end stage renal disease patients. World J Nephrol. 2014 Nov 6;3(4):308-16. doi: 10.5527/wjn.v3.i4.308.
Background: PubMed 21883901Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
Background: PubMed 21658828Molnar-Varga M, Molnar MZ, Szeifert L, Kovacs AZ, Kelemen A, Becze A, Laszlo G, Szentkiralyi A, Czira ME, Mucsi I, Novak M. Health-related quality of life and clinical outcomes in kidney transplant recipients. Am J Kidney Dis. 2011 Sep;58(3):444-52. doi: 10.1053/j.ajkd.2011.03.028. Epub 2011 Jun 12.
Background: PubMed 20685829Kovacs AZ, Molnar MZ, Szeifert L, Ambrus C, Molnar-Varga M, Szentkiralyi A, Mucsi I, Novak M. Sleep disorders, depressive symptoms and health-related quality of life--a cross-sectional comparison between kidney transplant recipients and waitlisted patients on maintenance dialysis. Nephrol Dial Transplant. 2011 Mar;26(3):1058-65. doi: 10.1093/ndt/gfq476. Epub 2010 Aug 4.
BackgroundCIHI, Annual Statistics on Organ Replacement in Canada: Dialysis, Transplantation and Donation, 2010 to 2019. 2020, Canadian Institute for Health Information: Ottawa, Ontario, Canada.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Istvan Mucsi contact

4166596756

istvan.mucsi@utoronto.ca

Ana M Samudio contact

4163404800 ext. 2032

ana.samudio@uhn.ca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EASE-SOT in people with Transplant;Failure,Kidney and Transplant; Failure, Heart, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Istvan Mucsi (4166596756, istvan.mucsi@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Target (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06396702, which also lists 108 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.