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A Virtual Post-Discharge Intervention For Patients With CKD

NCT ID: NCT05274347

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Multi-faceted virtual, remote intervention

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.

Group Type EXPERIMENTAL

Muti-faceted virtual, remote intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amber O Molnar, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Central Contacts

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Amber O Molnar, MD, MSc

Role: CONTACT

Phone: 905-522-1156

Email: [email protected]

Other Identifiers

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14620

Identifier Type: -

Identifier Source: org_study_id