COA-APTIC Caregiver Concept Elicitation Study

NCT04392180 | Completed

• 1 other identifier: Pro00105117
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a concept elicitation study to identify important aspects of pain assessment, treatment, and response to treatment in children under than 3 years of age from a caregiver's perspective.

Conditions

Pain Measurement

Keywords

acute pain; pediatrics

Outcome Measures

Primary Outcomes (4)

• Caregiver perspective on how to identify or recognize pain in children 0 to <3 years old.

  A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess how caregivers identify and recognize acute pain in infants and young children.

  1 hour

• Caregiver perspective on how and when to intervene for acute pain in children 0 to <3 years old.

  A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess caregiver's perspective on how and when to treat acute pain in infants and young children.

  1 hour

• Caregiver perspective on how to evaluate response to treatment for acute pain in children 0 to <3 years old.

  A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess how caregivers evaluate response to treatment for acute pain in infants and young children.

  1 hour

• Caregiver perspective on important side effects of acute pain therapeutics in children 0 to <3 years old.

  A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess caregiver's perspective on important side effects of acute pain in infants and young children.

  1 hour

Study Arms (1)

Caregivers

Caregivers who care for a child that is both under 3 years of age and has experienced acute pain. This cohort will participate in a qualitative interview about pain assessment, treatment, and response to treatment in their child.

Other: Qualitative Interview

Interventions

Qualitative Interview OTHER

There is no intervention as part of this study. Caregivers will participate in a qualitative interview over the phone or by video.

Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be caregivers of children 0 to \<3 years old who have experienced acute pain. Eligible caregivers will be identified by Pediatric Trials Network sites across the United States. Eligible participants will be identified through recruitment for a pre-existing Pediatric Trials Network study called Pharmacokinetics and Safety of Anesthetics and Analgesics in Children and Adolescents.

You may qualify if:

• Cares for a child who is both:
• Between 0 and \<3 years of age
• Experiencing or has experienced acute pain in one of the following categories:
• Malignant or non-malignant visceral or hematologic disease
• Surgery (or other procedure)
• Trauma or injury
• Congenital conditions
• Is over the age of 18 years old.
• Can speak and understand English.
• Is capable of and willing to provide informed consent for interview participation and to collect medical data from the child's medical record.

You may not qualify if:

• Lack of access to a telephone or computer for interview
• Has a child with acute pain that is extremely premature (less than 32 weeks gestation at the time of enrollment) and no other eligible child.

Sponsors & Collaborators

• Duke University: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryce Reeve, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Kanecia Zimmerman, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 18, 2020
• Study Start: June 23, 2021
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: June 9, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)