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Clinical Trials/NCT05274347
NCT05274347
Not Yet Recruiting
N/A

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

McMaster University0 sites30 target enrollmentMarch 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
McMaster University
Enrollment
30
Primary Endpoint
Patient uptake of the intervention
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2025
End Date
March 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Patient uptake of the intervention

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • Change in disease self-efficacy(10 weeks)
  • Change in overall self-reported health(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)
  • Questionnaire completion(10 weeks)
  • Emergency room visits(10 weeks)
  • Change in self-reported quality of life(10 weeks)

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