A Virtual Post-Discharge Intervention For Patients With CKD

Chronic Kidney Diseases Clinical Trial

— VIDIO-CKD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05274347
• Other study ID #: 14620
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: Amber O Molnar, MD, MSc
• Phone: 905-522-1156
• Email: amolnar[@]stjosham.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient uptake of the intervention	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.	10 weeks
Primary	Patient acceptance of the intervention	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.	10 weeks
Secondary	Patients' reasons for not participating in virtual sessions.	This will be collected for further detail on the uptake of the intervention.	10 weeks
Secondary	Patient satisfaction with the intervention	Satisfaction with both the technology and virtual physiotherapy and CBT sessions. This outcome will be determined using a locally developed patient experience survey instrument that includes 13 questions asking patients to rate various elements of the intervention with the response options "strongly disagree", "disagree", "neutral", "agree", "strongly agree". The Satisfaction with Therapy and Therapist Scale- Revised (STTS-R) will be used to measure satisfaction with the CBT intervention.	Measured at 10 weeks (study end)
Secondary	Uptake of systolic and diastolic blood pressure monitoring	Mean number of missing blood pressure values per patient.	10 weeks
Secondary	Changes in management as a result of remote monitoring	Mean number of alert values per patient from the monitoring pathway, mean number of alerts that resulted in a change in management per patient, mean number of medication errors detected per patient	10 weeks
Secondary	Change in depression	Change in Patient Health Questionnaire-9 (PHQ-9) score (measured every 2 weeks). The PHQ-9 score ranges from 0 to 27. A higher score indicates a higher degree of depressive symptoms.	10 weeks
Secondary	Change in anxiety	Change in Generalized Anxiety Disorder-7 (GAD-7) score (measured every 2 weeks). The GAD-7 score ranges from 0 to 21, with a higher score indicating a higher degree of anxiety.	10 weeks
Secondary	Change in disease self-efficacy	Change in Self Efficacy for Managing Chronic Disease (SEMCD) score (measured every 2 weeks). The SEMCD score is the mean score from 6 items, with a means score range from 1 to 10. A higher score indicates higher self-efficacy	10 weeks
Secondary	Change in overall self-reported health	Measured every 2 weeks using the single question Global QOL score. Participants will be asked to rate their overall health as "excellent, good, fair, or poor".	10 weeks
Secondary	Change in self-reported quality of life	measured week 1, week 5 and week 10 using the Short Form-36 (SF-36) questionnaire. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability	10 weeks
Secondary	Questionnaire completion	Mean number of incomplete questionnaires per patient	10 weeks
Secondary	All-cause hospitalizations	Hospitalizations will be determined by patient report directly into their Aetonix tablet (weekly question) or clinical staff following up on alerts for missed CBT/physio sessions or >3 consecutive missed daily symptom/vitals questionnaires.	10 weeks
Secondary	Emergency room visits	Emergency room visits will be determined by patient report directly into their Aetonix tablet (weekly question) or clinical staff following up on alerts for missed CBT/physio sessions or >3 consecutive missed daily symptom/vitals questionnaires.	10 weeks