EASE for Organ Transplant Recipients

Overseen By Istvan Mucsi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: ICU, Clinically unstable, Delirium, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

120 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring and managing symptoms rather than changing existing treatments.

What data supports the effectiveness of the treatment EASE-SOT for organ transplant recipients?

Research suggests that exercise interventions can improve fitness and tolerance in organ transplant candidates, which may indirectly support the effectiveness of EASE-SOT if it includes exercise components. Additionally, exercise training has the potential to improve long-term outcomes like physical function and quality of life in transplant recipients. ^{1 2 3 4 5}

Is the EASE treatment generally safe for organ transplant recipients?

The available research does not provide specific safety data for the EASE treatment in organ transplant recipients, but it highlights the importance of monitoring medication safety and reporting adverse events in this population. ^{6 7 8 9 10}

How is the EASE treatment for organ transplant recipients different from other treatments?

The EASE treatment is unique because it uses a combination of clinical teaching and advanced technology to simplify medication education for organ transplant recipients, which is not typically a focus of other treatments. ^{10 11 12 13 14}

What is the purpose of this trial?

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: 1. 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. 2. 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.

Eligibility Criteria

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.

Inclusion Criteria

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

I consented to participate after receiving a transplant of kidney, liver, lung, heart, or kidney-pancreas at Ajmera Transplant Centre.

Exclusion Criteria

Unwilling or unable to provide informed consent

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 patient's organ transplant team or is documented in their medical chart, the patient will be assessed to have no cognitive impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the EASE intervention, including 8 supportive counseling sessions and regular physical symptom assessments using ePROMs.

8 weeks

Twice a week during inpatient stay, then once every 1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with additional ePROMs completed at baseline, 4, 8, 12, and 20 weeks.

12 weeks

ePROMs at 4, 8, 12, and 20 weeks

Long-term Follow-up

Participants continue to be monitored for post-transplant quality of life and symptom severity using PROMIS and other measures.

20 weeks

Treatment Details

Interventions

• EASE-SOT

Trial Overview 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.

Participant Groups

Group I: EASE-SOT Intervention Arm Experimental Treatment 1 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 Arm Active Control 1 Intervention

Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

A new patient education tool was developed to support solid organ transplant recipients after early hospital discharge, addressing the challenges of ensuring patient and family understanding of post-transplant care.

This tool aims to enhance self-care practices, promote wellness, and improve graft survival by providing essential information that can be easily reviewed during home care visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care guidelines: finding a common ground. Randolph, S., Scholz, K.[2019]

A pilot study involving 30 lung transplant recipients showed that a combination of group education and telephone coaching led to trends of lower weight gain and improved body composition compared to standard care over 12 months.

While the results were not statistically significant, the intervention group experienced less increase in weight, fat mass, and waist circumference, suggesting it may be a beneficial approach for managing weight post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we HALT obesity following lung transplant? A Dietitian- and Physiotherapy-directed pilot intervention. Emsley, C., Snell, G., Paul, E., et al.[2022]

Out of 543 serious adverse events reported in organ donation from 2016 to 2022, 53 cases (9.8%) were identified as proven or probable transmissions of diseases to recipients, highlighting the importance of monitoring disease transmission in organ transplantation.

Infections were the most common type of disease transmission, and the mortality rate among recipients who received infected organs was notably high at 23%, with a particularly alarming 50% mortality rate when malignant diseases were transmitted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vigilance Data in Organ Donation and Solid Organ Transplantation in Germany: Six Years of Experience 2016-2022. Böhler, K., Rahmel, A., Barreiros, AP.[2023]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Physical activity in solid organ transplant recipients: Participation, predictors, barriers, and facilitators. [2018]

2. Denmark pubmed.ncbi.nlm.nih.gov

Exercise interventions in solid organ transplant candidates: A systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Meeting report: consensus recommendations for a research agenda in exercise in solid organ transplantation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Self-care guidelines: finding a common ground. [2019]

5. Denmark pubmed.ncbi.nlm.nih.gov

Can we HALT obesity following lung transplant? A Dietitian- and Physiotherapy-directed pilot intervention. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Trends and Patterns in Reporting of Patient Safety Situations in Transplantation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Computer-Based Education Program in the Home for Solid Organ Transplant Recipients: Impact on Medication Knowledge, Satisfaction, and Adherence. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

A Randomized Control Trial Testing a Medication Safety Dashboard in Veteran Transplant Recipients. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Vigilance Data in Organ Donation and Solid Organ Transplantation in Germany: Six Years of Experience 2016-2022. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Using technology to enhance medication regimen education after solid organ transplantation. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical and Surgical Challenges in Kidney Transplantation: Toward a Personalized Approach? [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Primary Care of the Solid Organ Transplant Recipient. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Is Aesthetic Surgery Safe in the Solid Organ Transplant Patient? An International Survey and Review. [2017]

14. Spain pubmed.ncbi.nlm.nih.gov

Management of influenza infection in solid-organ transplant recipients: consensus statement of the Group for the Study of Infection in Transplant Recipients (GESITRA) of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) and the Spanish Network for Research in Infectious Diseases (REIPI). [2018]