A Virtual Post-Discharge Intervention For Patients With CKD

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other 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.

Primary outcome measures

• Patient uptake of the intervention [Time frame: 10 weeks]
• Patient acceptance of the intervention [Time frame: 10 weeks]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05274347 · 14620

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗