COPM-Based Goal Setting Strategies in the PICU

NCT07128446 | Recruiting

• 1 other identifier: 2025-08-032
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

COPM-Based Goal Setting Strategies in the PICU

Conditions

Critical Illness; Pediatric Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Consensus Level for COPM Implementation Criteria in the PICU (Delphi Survey)

  Level of expert consensus on specific clinical and procedural criteria for implementing COPM-based goal-setting in PICU, measured via a two-round online Delphi survey. Consensus is defined as ≥70% agreement (≥6/10 on a Likert scale) and mean score ≥7 for Likert items, or ≥50% selection for categorical items.

  From initial Delphi invitation to completion of second round (estimated 2-3 weeks).

Secondary Outcomes (2)

• Client-Centredness of Goal Setting (C-COGS)

  Immediately after pilot intervention completion.

• Caregiver Perceived Acceptability and Feasibility of COPM-Based Goal Setting in PICU

  Immediately after pilot intervention completion.

Study Arms (1)

Standard physical and occupational therapy

EXPERIMENTAL

Participants will receive standard physiacal and occupational therapy as routinely provided in the PICU. The therapy may include activities of daily living training, positioning, range of motion exercises, and caregiver education, according to each patient's condition. No experimental intervention is introduced; the study focuses on evaluating patient-centered outcomes using the Canadian Occupational Performance Measure.

Other: Standard physical and occupational therapy

Interventions

Standard physical and occupational therapy OTHER

Participants admitted to the Pediatric Intensive Care Unit (PICU) will receive standard occupational therapy as part of routine clinical care. Interventions will be tailored to each patient's medical status and functional needs and may include activities of daily living (ADL) training, positioning, range of motion exercises, sensory stimulation, and caregiver education. No additional experimental treatment will be introduced for study purposes. The primary focus of the study is to evaluate patient-centered outcomes using the Canadian Occupational Performance Measure (COPM), without altering the standard therapeutic approach.

Standard physical and occupational therapy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

NOT YET RECRUITING

Related Publications (1)

• Hwang Y, Kwon JY, Cho J, Choi J. Individualized Goal Setting for Pediatric Intensive Care Unit-Based Rehabilitation Using the Canadian Occupational Performance Measure. Children (Basel). 2023 May 31;10(6):985. doi: 10.3390/children10060985.

  PMID: 37371217 RESULT

MeSH Terms

Conditions

Critical Illness

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

JEONG-YI KWON, MD, PHD

CONTACT

+821045911039; jeongyi.kwon@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)