COPM-guided goal setting for children in the PICU
Development and Feasibility Evaluation of Canadian Occupational Performance Measure-Based Goal Setting Strategies for Pediatric Intensive Care Unit Patients: A Multi-Phase Mixed-Methods Study
NA · Samsung Medical Center · NCT07128446
This will try using the COPM tool with therapists and caregivers to set personalized rehabilitation goals for children aged 1–18 who are admitted to the PICU.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Locations | 2 sites (Seoul, Gangnam-gu and 1 other locations) |
| Trial ID | NCT07128446 on ClinicalTrials.gov |
What this trial studies
The project uses a COPM (Canadian Occupational Performance Measure)-based approach to structure goal setting in the pediatric intensive care unit. Initial Delphi phases will enroll experienced pediatric rehabilitation clinicians to shape the strategy, followed by a pilot phase that tests the approach with caregivers of children (aged 1–18) and the treating PICU occupational or physical therapists. Interventions consist of standard physical and occupational therapy delivered alongside COPM-guided goal discussions. The work is being conducted at Samsung Medical Center in Seoul and requires Korean-language participation for surveys and caregiver engagement.
Who should consider this trial
Good fit: Ideal candidates for the pilot phase are children aged 1–18 admitted to the PICU for at least 24 hours, their Korean-speaking legal guardians, and the treating PICU occupational or physical therapists.
Not a fit: Patients under age 1, those discharged before 24 hours, non-Korean-speaking families, or caregivers judged too distressed to participate are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could produce clearer, family-centered rehabilitation goals that improve therapy focus and potentially speed functional recovery.
How similar studies have performed: The COPM is well established in pediatric rehabilitation settings, but its formal use specifically within the PICU is relatively novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Phase 1-2 (Delphi Survey - Experts) * Physicians specializing in pediatrics or physical medicine and rehabilitation, occupational therapists, physical therapists, and nursing staff * Minimum of 2 years of direct clinical experience in a Pediatric Intensive Care Unit (PICU) Phase 3 (Pilot Testing - Caregivers \& PICU Clinicians) Caregivers: * Legal guardian of a child aged 1-18 years admitted to PICU * ≥24 hours post-admission PICU clinicians: \- Treating occupational or physical therapist involved in the child's care during PICU admission Exclusion Criteria: Phase 1-2 (Delphi Survey - Experts) * Rehabilitation professionals without prior PICU clinical experience * Inability to read or respond to Korean-language surveys Phase 3 (Pilot Testing - Caregivers \& PICU Clinicians) * Caregivers experiencing severe emotional distress, or deemed inappropriate for participation by the treating clinician * Non-Korean-speaking caregivers * Refusal or withdrawal of informed consent at any stage
Where this trial is running
Seoul, Gangnam-gu and 1 other locations
- Samsung Medical Center — Seoul, Gangnam-gu, South Korea (RECRUITING)
- Samsung Medical Center — Seoul, South Korea (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: JEONG-YI KWON, MD, PHD
- Email: jeongyi.kwon@samsung.com
- Phone: +821045911039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Pediatric Intensive Care Unit