Chronic Kidney DiseasesVIDIO-CKDNCT05274347
A Virtual Post-Discharge Intervention For Patients With CKD
A study testing Muti-faceted virtual, remote intervention in people with Chronic Kidney Diseases, run by McMaster University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Muti-faceted virtual, remote intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Virtual Post-Discharge Intervention to Prevent Hospital Re-Admissions in Patients With CKD
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Muti-faceted virtual, remote intervention
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muti-faceted virtual, remote interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Muti-faceted virtual, remote intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (12)
Patients' reasons for not participating in virtual sessions.
This will be collected for further detail on the uptake of the intervention.
Measured: 10 weeks
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: Measured at 10 weeks (study end)
Uptake of systolic and diastolic blood pressure monitoring
Mean number of missing blood pressure values per patient.
Measured: 10 weeks
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
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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
Measured: 10 weeks
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".
Measured: 10 weeks
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
Measured: 10 weeks
Questionnaire completion
Mean number of incomplete questionnaires per patient
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amber O Molnar, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274347
- Sponsor's protocol ID
- 14620
- Acronym
- VIDIO-CKD
- Status last verified
- Dec 2024
- First submitted
- 14 Feb 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Post-Discharge Intervention to Prevent Hospital Re-Admissions in Patients With CKD
- ClinicalTrials.gov ID
- NCT05274347
- Acronym / sponsor ID
- VIDIO-CKD / 14620
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-faceted virtual, remote intervention | Experimental | Other: Muti-faceted virtual, remote interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muti-faceted virtual, remote interventionPatients 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. | Other | Multi-faceted virtual, remote intervention |
Primary outcome
Patient uptake of the intervention
Time frame: 10 weeks
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
Time frame: 10 weeks
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.
12 secondary outcomes
Patients' reasons for not participating in virtual sessions.
Time frame: 10 weeks
Patient satisfaction with the intervention
Time frame: Measured at 10 weeks (study end)
Uptake of systolic and diastolic blood pressure monitoring
Time frame: 10 weeks
Changes in management as a result of remote monitoring
Time frame: 10 weeks
Change in depression
Time frame: 10 weeks
Change in anxiety
Time frame: 10 weeks
Change in disease self-efficacy
Time frame: 10 weeks
Change in overall self-reported health
Time frame: 10 weeks
Change in self-reported quality of life
Time frame: 10 weeks
Questionnaire completion
Time frame: 10 weeks
All-cause hospitalizations
Time frame: 10 weeks
Emergency room visits
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amber O Molnar, MD, MSc principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Muti-faceted virtual, remote intervention in people with Chronic Kidney Diseases, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber O Molnar, MD, MSc (905-522-1156 ext. 33191, amolnar@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient uptake of the intervention (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.