COPM-Based Goal Setting Strategies in the PICU

NCT ID: NCT07128446

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2025-12-31

Brief Summary

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COPM-Based Goal Setting Strategies in the PICU

Detailed Description

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Conditions

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Critical Illness Pediatric Intensive Care Unit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard physical and occupational therapy

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.

Group Type EXPERIMENTAL

Standard physical and occupational therapy

Intervention Type 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.

Interventions

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Standard physical and occupational therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Yi Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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JEONG-YI KWON, MD, PHD

Role: CONTACT

+821045911039

Facility Contacts

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Youngsub Hwang, Ph.D

Role: primary

+821065292034

References

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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.

Reference Type RESULT
PMID: 37371217 (View on PubMed)

Other Identifiers

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2025-08-032

Identifier Type: -

Identifier Source: org_study_id

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