- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623583
Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
A Randomized Controlled Study of the Effect of a Needle Phobia or Apprehension Intervention With or Without Synera® on Conversion From Central Venous Catheters to Arteriovenous Fistula or Graft
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with long-term CVCs (> 180 days) will be recruited for study participation by being asked "Why haven't you gotten a graft or fistula?" Those who indicate fear or discomfort with needles in the top 3 reasons will be consented into the study and administered the AVF/AVG Stages of Change Questionnaire.
The Stages of Change questionnaire has been used extensively in research and has been shown to be highly predictive of people engaging in the behavior of interest. The five stages of change include: 1) Precontemplation: Patient doesn't know about, or knows about but doesn't want to think about, a behavior change; 2) Contemplation: Patients knows about and is beginning to consider behavior change; 3) Planning: Patient is actively investigating and making plans for behavior change; 4) Action: Patient is committed to make the change and/or has taken concrete steps to change behavior; and 5) Maintenance: Patient has made the behavior change and is trying maintain that change.
Patients will be cluster-randomized to receive a standard needle phobia intervention (n = 32), or an enhanced intervention consisting of a standard intervention plus a demonstration of the Synera patch (n = 32) within 15 days of baseline. The intervention will be administered by a study team member. In clinics where there is more than 1 patient randomized to a group, the intervention can be administered to multiple patients simultaneously. The standard intervention will last approximately 20 to 30 minutes. During this time, patients will receive information about the advantages of arteriovenous fistula or graft over central-venous catheter, be taught basic relaxation breathing, see a brief video of a patient overcoming needle fear, and have the opportunity to safely interact with a cannulation needle. In the enhanced intervention, the patient will receive the standard intervention with 2 enhancements: (1) the video will include a segment in which a patient experiences the analgesic effects of the a Synera patch and (2) a Synera patch will be applied at the beginning of the intervention, and 30 minutes later the patient will be given the chance to explore the analgesic effects of Synera.
Patients will complete a Stages of Change questionnaire 1 week after the intervention. Patients will then be followed for 4 months to determine whether or not they have scheduled a vein mapping appointment or have had a fistula or graft access placed.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
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Rancho Cordova, California, United States, 95670
- Sunset Dialysis Center
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Sacramento, California, United States, 95834
- Natomas Dialysis
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North Carolina
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Asheville, North Carolina, United States, 28805
- Asheville Kidney Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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, may interfere with protocol adherence or subjects' ability to provide informed consent
- Patient is unable to read or comprehend English at a 6th grade level
- Patient has a visual impairment and is unable to read the survey instruments
- Patient has a suspected or known access-related infection at the time of enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Needle Phobia Intervention
Patients will receive enhanced needle phobia intervention comprising the standard intervention plus demonstration of Synera
|
The enhanced intervention will include the standard intervention, with two enhancements:
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Active Comparator: Standard Needle Phobia Intervention
Patients will receive the standard intervention for needle phobia
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The standard intervention will include the following components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire
Time Frame: One week after intervention meeting
|
The primary outcome measure is how many patients progress from a score of 1 or 2 on the questionnaire (precontemplation or contemplation) as measured before the intervention to a score of 3 or 4 (planning or action) after the intervention, and it is measured one week after the intervention.
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One week after intervention meeting
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients for whom the intervention was successful
Time Frame: Four months after intervention meeting
|
The secondary outcome measure will be assessed as a two-stage dichotomous indicator of intervention success.
Stage 1 will assess if a patient has had dialysis treatment with a fistula or graft as primary access.
If yes, the intervention will be considered a success; if no, stage 2 will ask if the patient has had a vein mapping procedure, which would be considered a success.
|
Four months after intervention meeting
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mahesh Krishnan, MD, MPH, MBA, DaVita Clinical Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-02-02-NVO-MI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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