Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use … (NCT04064086) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans
United States656 participantsStarted 2020-03-25
Plain-language summary
This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Veterans registered to receive healthcare from the NF/SG VHS
* 18 years or older
* Advanced CKD (stage 4 or 5) and not on dialysis
Exclusion Criteria:
* Non-English speakers
* Veterans who are homeless or living in assisted living facilities or nursing homes
* Veterans with diagnosed dementia
* Veterans with the life-expectancy less than 6 months
* Any additional special concerns of a Veteran's provider
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically studying whether comprehensive education before kidney failure affects whether veterans choose home dialysis — am I a veteran, and if so, could my doctor help me understand whether I'd be eligible to participate or benefit from this kind of pre-dialysis education program?
2Since this trial is no longer recruiting, does that mean the education approach being studied is already available to me now, or would I need to wait for the results before my care team could offer something similar?
3The trial is comparing home dialysis options like peritoneal dialysis and home hemodialysis against in-center hemodialysis — can my doctor walk me through what each of those actually looks like day-to-day for someone at my stage of kidney disease?
4Because this is a Phase N/A education study rather than a drug or device trial, what are the main risks or downsides of receiving intensive pre-dialysis education, and could it lead me toward a treatment path that isn't the best fit for my specific situation?
5If the results of this trial eventually show that early education increases home dialysis use, how might that change the way my care team prepares me for the possibility of dialysis in the future?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.