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A Virtual Post-Discharge Intervention For Patients With CKD (VIDIO-CKD)

Primary Purpose

Chronic Kidney Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muti-faceted virtual, remote intervention
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Unable to participate in physical therapy (as determined by treating physicians or inpatient physiotherapists) will be excluded from physical therapy but may still participate in the study if they otherwise meet all eligibility criteria.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Multi-faceted virtual, remote intervention

    Arm Description

    The intervention will use the Aetonix - aTouchAwayTM software platform (AETONIX Systems Inc). Each study participant will receive a tablet with Aetonix software. Interventions Components: 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. 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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Patients' reasons for not participating in virtual sessions.
    This will be collected for further detail on the uptake of the intervention.
    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"
    Uptake of systolic and diastolic blood pressure monitoring
    Mean number of missing blood pressure values per patient.
    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
    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.
    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.
    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
    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".
    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
    Questionnaire completion
    Mean number of incomplete questionnaires per patient
    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.
    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.

    Full Information

    First Posted
    February 14, 2022
    Last Updated
    October 20, 2023
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05274347
    Brief Title
    A Virtual Post-Discharge Intervention For Patients With CKD
    Acronym
    VIDIO-CKD
    Official Title
    A Virtual Post-Discharge Intervention to Prevent Hospital Re-Admissions in Patients With CKD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Multi-faceted virtual, remote intervention
    Arm Type
    Experimental
    Arm Description
    The intervention will use the Aetonix - aTouchAwayTM software platform (AETONIX Systems Inc). Each study participant will receive a tablet with Aetonix software. Interventions Components: 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. 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Muti-faceted virtual, remote intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Patient uptake of the intervention
    Description
    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.
    Time Frame
    10 weeks
    Title
    Patient acceptance of the intervention
    Description
    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.
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Patients' reasons for not participating in virtual sessions.
    Description
    This will be collected for further detail on the uptake of the intervention.
    Time Frame
    10 weeks
    Title
    Patient satisfaction with the intervention
    Description
    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"
    Time Frame
    Measured at 10 weeks (study end)
    Title
    Uptake of systolic and diastolic blood pressure monitoring
    Description
    Mean number of missing blood pressure values per patient.
    Time Frame
    10 weeks
    Title
    Changes in management as a result of remote monitoring
    Description
    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
    Time Frame
    10 weeks
    Title
    Change in depression
    Description
    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.
    Time Frame
    10 weeks
    Title
    Change in anxiety
    Description
    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.
    Time Frame
    10 weeks
    Title
    Change in disease self-efficacy
    Description
    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
    Time Frame
    10 weeks
    Title
    Change in overall self-reported health
    Description
    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".
    Time Frame
    10 weeks
    Title
    Change in self-reported quality of life
    Description
    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
    Time Frame
    10 weeks
    Title
    Questionnaire completion
    Description
    Mean number of incomplete questionnaires per patient
    Time Frame
    10 weeks
    Title
    All-cause hospitalizations
    Description
    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.
    Time Frame
    10 weeks
    Title
    Emergency room visits
    Description
    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.
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amber O Molnar, MD, MSc
    Phone
    905-522-1156
    Ext
    33191
    Email
    amolnar@stjosham.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amber O Molnar, MD, MSc
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Virtual Post-Discharge Intervention For Patients With CKD

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