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COPM-Based Goal Setting Strategies 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07128446
Enrollment
5
Registered
2025-08-19
Start date
2025-08-29
Completion date
2026-12-31
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Pediatric Intensive Care Unit

Brief summary

COPM-Based Goal Setting Strategies in the PICU

Interventions

OTHERStandard 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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
Client-Centredness of Goal Setting (C-COGS)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.
Caregiver Perceived Acceptability and Feasibility of COPM-Based Goal Setting in PICUImmediately 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.

Countries

South Korea

Contacts

CONTACTJEONG-YI KWON, MD, PHD
jeongyi.kwon@samsung.com+821045911039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026