A Virtual Post-Discharge Intervention For Patients With CKD

Study Overview
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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.

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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: Muti-faceted virtual, remote intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-faceted virtual, remote intervention<br>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. | Behavioral: Muti-faceted virtual, remote intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' reasons for not participating in virtual sessions. | This will be collected for further detail on the uptake of the intervention. | 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 | Measured at 10 weeks (study end) | 
| Uptake of systolic and diastolic blood pressure monitoring | Mean number of missing blood pressure values per patient. | 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 | 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. | 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. | 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 | 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. | 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 | 10 weeks | 
| Questionnaire completion | Mean number of incomplete questionnaires per patient | 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. | 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. | 10 weeks |