EASE-SOT Pilot Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое EASE-SOT
  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

Первичные конечные точки

• Recruitment Target [Срок оценки: Baseline]
• Consent Rate [Срок оценки: Baseline]
• Retention Rate [Срок оценки: Baseline to week 8 (8 weeks)]
• Adherence Rate [Срок оценки: Baseline to week 20 (20 weeks)]
• Drop-out Rate [Срок оценки: Baseline to week 20 (20 weeks)]
• Patient Acceptability [Срок оценки: Baseline to week 20 (20 weeks)]
• Clinical Team Acceptability [Срок оценки: Baseline to week 20 (20 weeks)]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Toronto General Hospital — Toronto

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 25374827

Идентификаторы

NCT: NCT06396702 · 22-6002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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