A Virtual Post-Discharge Intervention For Patients With CKD
- Conditions
- Chronic Kidney Diseases
- Interventions
- Other: Muti-faceted virtual, remote intervention
- Registration Number
- NCT05274347
- Lead Sponsor
- McMaster University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Multi-faceted virtual, remote intervention Muti-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.
- Primary Outcome Measures
Name Time Method Patient uptake of the intervention 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 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.
- Secondary Outcome Measures
Name Time Method Change in disease self-efficacy 10 weeks 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 10 weeks 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".
Uptake of systolic and diastolic blood pressure monitoring 10 weeks Mean number of missing blood pressure values per patient.
Change in depression 10 weeks 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.
All-cause hospitalizations 10 weeks 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.
Patients' reasons for not participating in virtual sessions. 10 weeks This will be collected for further detail on the uptake of the intervention.
Patient satisfaction with the intervention Measured at 10 weeks (study end) 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.
Changes in management as a result of remote monitoring 10 weeks 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 anxiety 10 weeks 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.
Questionnaire completion 10 weeks Mean number of incomplete questionnaires per patient
Emergency room visits 10 weeks 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.
Change in self-reported quality of life 10 weeks 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