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Caregiver for Acute Pain (COA-APTIC Trial)
N/A
Recruiting
Led By Kanecia Zimmerman, MD, MPH
Research Sponsored by Duke University
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 approximately 1 hour
Awards & highlights
COA-APTIC Trial Summary
Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to <2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - <2 years).
COA-APTIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who find the indicators included in the clinical outcome assessments complete and relevant
Number of participants who understand features of the clinical outcome assessments
COA-APTIC Trial Design
2Treatment groups
Experimental Treatment
Group I: ClinicianExperimental Treatment1 Intervention
Participants will take part in a semi-structured qualitative interview (~1 hour).
The first set of questions will provide an opportunity for the clinicians to describe observable indicators that a young child is in pain.
4 YouTube video links based on age groups (birth to 1 month,1 month to 6 months, 6 months to 12 months, and12 months to 24 months), will be reviewed by participants. Clinicians will be asked to rate the child's pain using the ClinRO measures while being probed for question content and understanding.
Subsequently, the cognitive interview scripts will be structured to evaluate different components of the ClinRO measures, including the instructions, the question stems, the response options, and other key aspects of the COA. Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.
Group II: CaregiverExperimental Treatment1 Intervention
Participants will take part in a semi-structured qualitative interview (~1 hour).
The first set of questions will provide an opportunity for the caregiver to describe the type of conditions or injuries their child has experienced and how their child reacted to the potentially painful experiences.
Subsequently, the cognitive interview scripts will be structured to evaluate different components of the questionnaire (ObsRO measure), including the instructions, the question stems, the response options, and other key aspects of the COA.Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,420,582 Total Patients Enrolled
9 Trials studying Acute Pain
8,342 Patients Enrolled for Acute Pain
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,546 Total Patients Enrolled
1 Trials studying Acute Pain
1,709 Patients Enrolled for Acute Pain
Kanecia Zimmerman, MD, MPHPrincipal InvestigatorDuke University
5 Previous Clinical Trials
4,932 Total Patients Enrolled
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