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临床试验/NCT07128446
NCT07128446招募中不适用

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

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2025年8月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
5
试验地点
2
主要终点
Consensus Level for COPM Implementation Criteria in the PICU (Delphi Survey)

研究概览

简要总结

COPM-Based Goal Setting Strategies in the PICU

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Standard physical and occupational therapy (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Client-Centredness of Goal Setting (C-COGS)(Immediately after pilot intervention completion.)
  • Caregiver Perceived Acceptability and Feasibility of COPM-Based Goal Setting in PICU(Immediately after pilot intervention completion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Yi Kwon

Professor

Samsung Medical Center

研究点 (2)

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