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Behavioural Intervention
Home-Based Care for Advanced Kidney Disease
N/A
Recruiting
Led By Susan Wong, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who receive primary +/- nephrology care from VAPS as defined by having at least 1 outpatient primary or nephrology visit in the prior year
Patients who are unsure or do not wish to undergo maintenance dialysis
Must not have
Patients currently receiving maintenance dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new way of caring for patients with advanced kidney disease who have decided not to start dialysis. The study will see if this new care plan is practical and acceptable to patients, their
Who is the study for?
This trial is for patients with advanced chronic kidney disease who have decided not to start maintenance dialysis. It's a pilot study to see if a new conservative care pathway works well and is accepted by patients, their caregivers, and healthcare providers.
What is being tested?
The intervention being tested is a novel conservative care (CC) program designed as an alternative to regular dialysis treatment for those with severe kidney issues. The study randomly assigns participants to receive this CC program at home.
What are the potential side effects?
Since the trial involves non-dialytic management of kidney disease, side effects may include symptoms related to declining kidney function such as fatigue, swelling, shortness of breath, or changes in urination patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have seen a primary care or kidney doctor at VAPS in the last year.
Select...
I am unsure or do not want to start long-term dialysis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on maintenance dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Caregiver interviews
Clinician interviews
Document Review
+2 moreSecondary study objectives
Attrition
Consultation Satisfaction Questionnaire
EQ-5D-5L
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CC Program Received InterventionExperimental Treatment1 Intervention
The CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care.
Group II: Usual CareActive Control1 Intervention
Does not receive intervention.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,836 Total Patients Enrolled
Susan Wong, MD MSPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA