跳至主要内容
临床试验/NCT05274347
NCT05274347尚未招募不适用

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

McMaster University0 个研究点目标入组 30 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Patient uptake of the intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Multi-faceted virtual, remote intervention

Experimental

The intervention will use the Aetonix - aTouchAwayTM software platform (AETONIX Systems Inc). Each study participant will receive a tablet with Aetonix software. Interventions Components:

  1. Cognitive behavioral therapy (CBT): After discharge, patients will receive weekly group CBT sessions delivered virtually by a psychologist. Throughout the series of CBT sessions, patients will learn strategies for problem-solving, assertive communication, relaxation, behavioural activation, time-based pacing, challenging unhelpful thinking, building motivation, and goal setting.
  2. Remote monitoring of vital signs and symptoms: Messages will be sent to patients asking them to measure their vitals, to report symptoms, and answer questions about medications. Concerning responses will be flagged for review by the patient's healthcare team.

干预措施: Muti-faceted virtual, remote intervention (Other)

结局指标

主要结局

Patient uptake of the intervention

时间窗: 10 weeks

Patient use of the Aetonix platform and virtual intervention components. Uptake of the virtual CBT intervention will be determined by the number of attended sessions.

Patient acceptance of the intervention

时间窗: 10 weeks

Acceptability of the technology will be determined by the proportion of patients who provide a mean Telehealth Usability Questionnaire (TUQ) score \>5/7. The mean TUQ score ranges from 1 to 7, with a higher score indicating greater acceptance of the intervention.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

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