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Nurse-Pharmacist Counseling for Medication Adherence (COLLAB Trial)
N/A
Waitlist Available
Led By Tonia Carr, BSN
Research Sponsored by Tonia Carr
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days following study visit
Awards & highlights
COLLAB Trial Summary
This trial looks at how a counseling session can help people learn more about their biologic medication, increase their confidence in taking it and prevent side effects.
Who is the study for?
This trial is for adults who are starting a biologic medication (omalizumab, risankizumab-rzaa, or ustekinumab) at the University of Kentucky Specialty and Infusion Services and will be self-administering it at home. It's not for those under 18, non-English speakers, patients who have had these drugs elsewhere, or won't be doing self-injections.Check my eligibility
What is being tested?
The study tests if counseling by nurses and pharmacists can boost patient understanding and confidence in using biologics on their own after initial office administration. Participants will answer surveys before and after counseling to measure this effect.See study design
What are the potential side effects?
While the intervention itself may not cause side effects, participants' experiences with potential side effects from their specific biologic medications will be monitored over six months.
COLLAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days following study visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days following study visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in patient-perceived medication knowledge and confidence.
Secondary outcome measures
Medication adherence/persistence
Medication adverse events/self-administration errors
COLLAB Trial Design
1Treatment groups
Experimental Treatment
Group I: Collaborative nurse-pharmacist counselingExperimental Treatment1 Intervention
Collaborative nurse-pharmacist counseling - At the interventional appointment, study participants will first complete a modified Okere-Reiner pre-survey assessing patient perceptions of confidence and knowledge in their biologic therapy. Subsequently, a pharmacist will perform a refresher medication counseling, detailing indication, dosing, storage, and side effects. Upon completion of this counseling, an infusion nurse will then provide education demonstrating proper self-administration to the patient. The patient will then self-administer the medication with coaching and direct observation from the nurse. Afterwards, the patient will complete the Okere-Reiner post-survey to determine the effectiveness of the counseling session at improving perceived confidence and knowledge. Patients will complete both the pre-and post-surveys with direct entry to REDCap on an institution iPad during the study intervention visit.
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Who is running the clinical trial?
Tonia CarrLead Sponsor
Tonia Carr, BSNPrincipal InvestigatorUniversity of Kentucky
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I do not speak English.I will not be giving myself treatments at home.I do not manage my own medication.I am taking omalizumab, risankizumab-rzaa, or ustekinumab.I am referred to the University of Kentucky for special medication administration.I will be giving myself the medication.
Research Study Groups:
This trial has the following groups:- Group 1: Collaborative nurse-pharmacist counseling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experiment currently available to participants?
"Clinicaltrials.gov confirms that this medical experiment, which first appeared on May 1st 2023 and was last altered on April 3rd 2023, is not recruiting anymore. Fortunately, there are 134 other trials still open for applications from patients."
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