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NCT Number: NCT07128446

COPM-Based Goal Setting Strategies in the PICU

COPM-Based Goal Setting Strategies in the PICU

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Intensive Care Unit

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center, Seoul, Gangnam-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Client-Centredness of Goal Setting (C-COGS)

    Time frame: Immediately after pilot intervention completion.

    C-COGS questionnaire will assess the extent to which client-centred principles are reflected in goal-setting for PICU caregivers. The tool includes 13 items across two subscales: Participation (9 items, max 45 points) and Goal Subscale (up to 24 items). Total scores range from 0-50, with higher scores indicating greater client-centredness.

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

    Time frame: Immediately after pilot intervention completion.

    Structured survey developed for this study, based on items from MPOC-20, to assess caregiver perceptions of acceptability, feasibility, and perceived clinical relevance of the COPM-based goal-setting strategy. The survey includes 9 items (7 quantitative on 5-point Likert scale, 2 open-ended for qualitative analysis). Higher scores indicate greater perceived acceptability and feasibility.

Study contacts

Contact information is provided by the study sponsor or research team.

JEONG-YI KWON, MD, PHD

CONTACT

[email protected]

+821045911039

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Mar 10, 2026

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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