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临床试验/NCT07055334
NCT07055334尚未招募不适用

Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation

Wei XIA, PhD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus

研究概览

简要总结

This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 3 to 7 years
  • •Clinical diagnosis of congenital heart disease
  • •Underwent a single open-heart surgical correction under direct vision at the study site
  • •Ability to communicate in Chinese

排除标准

  • •Postoperative arrhythmia
  • •Comorbid neurological, respiratory, or other systemic diseases
  • •Deemed unsuitable for exercise by a physician
  • •Cardiac function classified as NYHA Class IV
  • •Intellectual, language, or motor impairments resulting from perioperative complications or other causes
  • •Caregivers of Children With Congenital Heart Disease After Surgery
  • •Inclusion Criteria:
  • •Primary caregiver who voluntarily provides care
  • •Caregiver who spends the most time with the child
  • •Ability to communicate in Chinese
  • •Exclusion Criteria:
  • •Caregivers of children who voluntarily discontinued treatment before completion
  • •Paid or professional caregivers
  • •Diagnosed cognitive impairment or mental illness
  • •Inability to communicate effectively through spoken language
  • •Presence of serious conflict or instability in the caregiver-child relationship
  • •Inability to independently operate or use smart electronic devices and the internet
  • •Medical Professionals Involved in Congenital Heart Disease Care
  • •Inclusion Criteria:
  • •Licensed healthcare professionals, including physicians, nurses, dietitians, physical therapists, or psychological counselors
  • •At least 5 years of professional experience in congenital heart disease care, rehabilitation, or education
  • •Exclusion Criteria:
  • •Not currently engaged in frontline clinical work
  • •Not engaged in clinical work within the past year due to leave, study, or reassignment

结局指标

主要结局

Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus

时间窗: 12 months (from initiation to completion of scheme development)

The home rehabilitation scheme will be developed using a two-round Delphi method with a multidisciplinary expert panel. Each proposed module will be rated by experts for its relevance, feasibility, and clarity. Components reaching ≥75% agreement (rated as "agree" or "strongly agree") will be considered finalized. The outcome will be reported as the number and percentage of components finalized out of all proposed components.

次要结局

未报告次要终点

研究者

发起方
Wei XIA, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wei XIA, PhD

Associate professor

Sun Yat-sen University

研究点 (1)

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