A Virtual Post-Discharge Intervention For Patients With CKD

NCT05274347 | Not Yet Recruiting

• 1 other identifier: 14620
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Patients' reasons for not participating in virtual sessions.

  10 weeks

• Patient satisfaction with the intervention

  Measured at 10 weeks (study end)

• Uptake of systolic and diastolic blood pressure monitoring

  10 weeks

• Changes in management as a result of remote monitoring

  10 weeks

• Change in depression

  10 weeks

Study Arms (1)

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.

Other: Muti-faceted virtual, remote intervention

Interventions

Muti-faceted virtual, remote intervention OTHER

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.

Multi-faceted virtual, remote intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amber O Molnar, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber O Molnar, MD, MSc

CONTACT

905-522-1156; amolnar@stjosham.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share