Clinical trial NCT05274347: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Patient uptake of the intervention
timeFrame: 10 weeks
measure: Patient acceptance of the intervention
timeFrame: 10 weeks
Secondary outcomes:
measure: Patients' reasons for not participating in virtual sessions.
timeFrame: 10 weeks
measure: Patient satisfaction with the intervention
timeFrame: Measured at 10 weeks (study end)
measure: Uptake of systolic and diastolic blood pressure monitoring
timeFrame: 10 weeks
measure: Changes in management as a result of remote monitoring
timeFrame: 10 weeks
measure: Change in depression
timeFrame: 10 weeks
measure: Change in anxiety
timeFrame: 10 weeks
measure: Change in disease self-efficacy
timeFrame: 10 weeks
measure: Change in overall self-reported health
timeFrame: 10 weeks
measure: Change in self-reported quality of life
timeFrame: 10 weeks
measure: Questionnaire completion
timeFrame: 10 weeks
measure: All-cause hospitalizations
timeFrame: 10 weeks
measure: Emergency room visits
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Amber O Molnar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: