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Completed

NCT Number: NCT04392180

COA-APTIC Caregiver Concept Elicitation Study

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.

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Key information

Conditions

Pain Measurement Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27701, United States

About this study

The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials for acute pain therapeutics in infants and young children from a caregiver's perception. Study team members will conduct phone-based qualitative interviews, using a semi-structured interview guide, with 42 primary caregivers of pediatric patients under 3 years of age who are experiencing or have experienced acute pain. Once participants give verbal consent, they will fill out a demographics form. Interviews will last about one hour and will address the participant's experience recognizing and managing their child's acute pain. The investigators will use these concept elicitation interviews to identify important aspects of acute pain assessment, treatment, and response to treatment in children who are under 3 years old. Interviews will be audio recorded and transcribed with participant permission. Transcripts or interviewer notes will be reviewed by two analysts and will be double coded until inter-rater reliability is reached by agreement of at least 80%. The study team will conduct a thematic analysis of the coded transcripts. This is a minimal risk study. All information will be kept confidential and information will be stored on a secure network which is only accessible to the study team.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 hour

    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.

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

    Time frame: 1 hour

    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.

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

    Time frame: 1 hour

    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.

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

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

COA-APTIC Caregiver Concept Elicitation Study: A Qualitative Concept Elicitation Study to Identify Important Aspects of Pain Assessment, Treatment, and Response to Treatment in Children Who Are 0 to <3 Years of Age

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 18, 2020
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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