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COPM-Based Goal Setting Strategies in the PICU
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Client-Centredness of Goal Setting (C-COGS) | 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. | Immediately after pilot intervention completion. |
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Inclusion Criteria:
Phase 1-2 (Delphi Survey - Experts)
Phase 3 (Pilot Testing - Caregivers & PICU Clinicians)
Caregivers:
PICU clinicians:
- Treating occupational or physical therapist involved in the child's care during PICU admission
Exclusion Criteria:
Phase 1-2 (Delphi Survey - Experts)
Phase 3 (Pilot Testing - Caregivers & PICU Clinicians)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JEONG-YI KWON, MD, PHD | Contact | +821045911039 | jeongyi.kwon@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Gangnam-gu | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37371217 | Result | 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. |
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Individual participant data will not be shared. The dataset includes sensitive clinical information from PICU patients and their caregivers. Due to concerns about patient privacy, potential re-identification risk, and institutional review boardrestrictions, IPD will be used solely for the purposes defined in the approved protocol and will not be made available for external access.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Caregiver Perceived Acceptability and Feasibility of COPM-Based Goal Setting in PICU | 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. | Immediately after pilot intervention completion. |
| Samsung Medical Center | Not yet recruiting | Seoul | 06351 | South Korea |
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| D013812 |
| Therapeutics |