TerminatedPhase 4

Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias

Stopped: limited qualifying patient population

United States10 participantsStarted 2014-04

Plain-language summary

An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the eligibility criterial will be asked to participate. Patients will receive either a standard or an enhanced intervention to address their fear of needles. The enhanced intervention includes the standard intervention plus video training about Synera and trying out an actual patch. Over the 4 months following the intervention, how many patients sign up to switch access will be tracked.

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: * Patient receiving hemodialysis at a DaVita clinic/dialysis center * Receiving in-center hemodialysis thrice weekly * Central venous catheter (CVC) use for \> 180 days * Patients report a fear of needles as a top-3-reason for failure to get an arteriovenous fistula/graft Exclusion Criteria: * Patients have a known intolerance or hypersensitivity to Synera * Patient with a history of or past diagnosis of severe hepatic disease * Patient is currently receiving any class 1 antiarrhythmic drugs (i.e., tocainide, mexiletine, etc) * Patient has a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study * Patient has an AVF or AVG in place or is scheduled for placement * Women and men whose partners are of childbearing potential (defined as premenopausal and not surgically sterilized \[ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\] or postmenopausal for \< 2 years) agree to practice 1 of the following medically acceptable methods of birth control and agree to continue with the regimen throughout the duration of the study: Oral, implantable, or injectable contraceptives for 3 consecutive months before the Screening Visit; Intrauterine device (IUD); and double barrier method (ie, condom, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream) * Patient has significant disease or condition that, in the PI's opinion, …

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire

Timeframe: One week after intervention meeting

Trial details

NCT IDNCT01623583

SponsorDavita Clinical Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

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