Critical IllnessNCT07128446
COPM-Based Goal Setting Strategies in the PICU
A study testing Standard physical and occupational therapy in people with Critical Illness and Pediatric Intensive Care Unit, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
COPM-Based Goal Setting Strategies in the PICU Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Critical Illness, Pediatric Intensive Care Unit
- What is being tested?
- Standard physical and occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 29 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- ≥24 hours post-admission
- PICU clinicians:
- Treating occupational or physical therapist involved in the child's care during PICU admission
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 06351
JEONG-YI KWON, Ph.D, +821065292034, jeongyi.kwon@samsung.com
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
Youngsub Hwang, Ph.D, +821065292034, asiaargento@naver.com
About this study
Official 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
COPM-Based Goal Setting Strategies in the PICU
- Conditions
- Critical Illness, Pediatric Intensive Care Unit
- Being tested
- Standard physical and occupational therapy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physical and occupational therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard physical and occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initial Delphi invitation to completion of second round (estimated 2-3 weeks).
Secondary outcomes (2)
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.
Measured: Immediately after pilot intervention completion.
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.
Measured: Immediately after pilot intervention completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start29 Aug 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128446
- Sponsor's protocol ID
- 2025-08-032
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37371217
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07128446
- Acronym / sponsor ID
- 2025-08-032
- Conditions
- Critical Illness, Pediatric Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COPM-Based Goal Setting Strategies in the PICU
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard physical and occupational therapy | Experimental | Other: Standard physical and occupational therapyParticipants 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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)
- Legal guardian of a child aged 1-18 years admitted to PICU
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard physical and occupational therapyParticipants 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. | Other | Standard physical and occupational therapy |
Primary outcome
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.
2 secondary outcomes
Client-Centredness of Goal Setting (C-COGS)
Time frame: Immediately after pilot intervention completion.
Caregiver Perceived Acceptability and Feasibility of COPM-Based Goal Setting in PICU
Time frame: Immediately after pilot intervention completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 37371217Hwang 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physical and occupational therapy in people with Critical Illness and Pediatric Intensive Care Unit, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JEONG-YI KWON, MD, PHD (+821045911039, jeongyi.kwon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07128446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.