A Virtual Post-Discharge Intervention For Patients With CKD

Официальное название

A Virtual Post-Discharge Intervention to Prevent Hospital Re-Admissions in Patients With CKD

Обзор

This pilot, interventional study is testing a combination of remote, virtual interventions, delivered to patients at home to patients with chronic kidney disease (CKD), with the goal of reducing admissions to hospital.

Подробное описание

Chronic kidney disease and kidney failure increase the risk of hospitalizations. Many hospital admissions are potentially avoidable. This pilot, interventional study is testing a combination of remote, virtual interventions, delivered to patients at home, with the goal of reducing admissions to hospital. The hypothesis for this pilot work is that the proposed interventions will be adopted by patients and will improve mental health, physical function, quality of life, and disease self-management, which are all key potential mediators of hospital readmission risk in patients with chronic kidney disease.

Вмешательства

• Другое Muti-faceted virtual, remote intervention
  Patients will be provided with tablets with internet connectivity and Aetonix software, along with a blood pressure cuff, weigh scale and pulse oximeter with blue tooth capability. These will be used to deliver virtual CBT sessions as well as remote monitoring of vital signs, symptoms and enhanced communication. The intervention duration will be 10 weeks.

Первичные конечные точки

• Patient uptake of the intervention [Срок оценки: 10 weeks]
• Patient acceptance of the intervention [Срок оценки: 10 weeks]

Вторичные конечные точки (12)

• Patients' reasons for not participating in virtual sessions. [Срок оценки: 10 weeks]
• Patient satisfaction with the intervention [Срок оценки: Measured at 10 weeks (study end)]
• Uptake of systolic and diastolic blood pressure monitoring [Срок оценки: 10 weeks]
• Changes in management as a result of remote monitoring [Срок оценки: 10 weeks]
• Change in depression [Срок оценки: 10 weeks]
• Change in anxiety [Срок оценки: 10 weeks]
• Change in disease self-efficacy [Срок оценки: 10 weeks]
• Change in overall self-reported health [Срок оценки: 10 weeks]
• Change in self-reported quality of life [Срок оценки: 10 weeks]
• Questionnaire completion [Срок оценки: 10 weeks]
• All-cause hospitalizations [Срок оценки: 10 weeks]
• Emergency room visits [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

• Adults with CKD (defined as an estimated glomerular filtration rate <30mL/min/1.73m2, including hemodialysis)
• Able to provide informed consent.
• Ongoing follow-up by the St Joseph's Hospital Hamilton Kidney Care Clinic or Dialysis Program and with a recent hospital admission.

Критерии исключения

• Unable to speak or understand English.
• Significant cognitive impairment (as per the treating inpatient care team)
• Serious mental illness (schizophrenia, severe untreated bipolar disorder, psychosis, active suicidal ideation)
• Significant vision or hearing impairment that prevents use of the technology or participation in any of the intervention components.
• Being discharged to long-term care, rehab or complex care.
• Peritoneal dialysis
• Home hemodialysis
• Functioning kidney transplant

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05274347 · 14620

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗