이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Case Management for Microtia

2026년 9월 23일 업데이트: Jing Xu

Development and Application of an Intelligent Whole-course Case Management Model for Patients With Microtia

The aim of this study is to develop an intelligent, full-course case management model for patients with microtia, enabling them to receive continuous, individualized nursing and health management services across the stages from diagnosis and treatment to rehabilitation.

The study seeks to address the following questions:

What practical needs do patients with microtia and their families have throughout the treatment process? How can case management and an information-based platform be used to provide continuous, personalized health management for these patients? Does implementation of an intelligent case management model improve patient health education, follow-up management and care experience?

What will participants be asked to do? During microtia-related diagnosis and treatment,

Participants will:

Establish a personal health record documenting disease- and treatment-related information; Receive stage-specific, individualized health education and nursing guidance; Obtain treatment reminders, follow-up notifications and rehabilitation tasks via an information platform; Complete corresponding health management tasks under the guidance of healthcare professionals; Communicate online with healthcare providers through the platform and provide timely feedback on treatment and rehabilitation; Undergo scheduled follow-up and outcome assessments. Through these procedures, the research team will integrate patients' fragmented needs for diagnosis, treatment, nursing and rehabilitation at different stages, forming a continuous management process that spans the entire course of care.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This study comprises two phases. In phase I, a case-management platform for patients with microtia will be developed. Semi-structured interviews with patients, family members, plastic surgeons, anaesthesiologists, clinical nurses and social workers, together with a literature review and expert meetings, will be conducted to inform platform design. Phase II is the effectiveness evaluation. Patients admitted for ear reconstruction surgery at the Eye, Ear, Nose and Throat Hospital of Fudan University between January and June 2026 will be assigned to the control group and receive routine care. Patients admitted between July and December 2026 will be assigned to the intervention group and receive care supported by the microtia case-management platform. Recruitment for the intervention cohort will begin after completion of control cohort enrolment, with no overlap. No randomisation will be performed. Primary and secondary outcomes will be compared between the two cohorts.

연구 유형

중재적

등록 (추정된)

188

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Shanghai, 중국, 201112
        • 모병
        • EYE & ENT Hospital, Fudan University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

6년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Aged 6-40 years
  • Meeting the diagnostic criteria for microtia as defined in Plastic Surgery of China, presenting typical microtia morphology and undergoing auricular reconstruction
  • Patients undergoing staged total ear reconstruction (including first-stage framework placement and ear elevation) or expander-based total ear reconstruction (expander implantation and semi-covered technique); temporoparietal fascia flap surgery; external auditory canal surgery

Exclusion Criteria:

  • Abnormal coagulation or other laboratory findings
  • Absence of normal fascial coverage of the affected ear, or presence of eczema, infection or other local pathology on the affected side
  • Severe cognitive impairment or psychiatric disorders
  • Concomitant major organ dysfunction
  • Refusal by the patient or family to participate in the study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control group

The control group will receive standard care according to current departmental practice, including routine perioperative nursing, conventional health education, discharge guidance and standard follow-up, without use of the intelligent case-management platform.

실험적: Intervention group

In addition to standard care, the intervention group will use the microtia case-management platform.

An intelligent, whole-course case-management model will be implemented for patients with microtia. Continuous electronic health records will be established, and stage-specific individualized health education, rehabilitation guidance and follow-up tasks will be provided. The platform will enable health information updates, task check-ins, message-based communication and online follow-up.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of postoperative complications after ear reconstruction
기간: Assessed 3 months postoperatively

This study includes common complications after ear reconstruction, namely haematoma, infection, flap necrosis, framework exposure and pressure injury. The incidence of postoperative complications is calculated as: incidence = (number of patients with complications / total number of patients) × 100%.

Assessed 3 months postoperatively

2차 결과 측정

결과 측정
측정값 설명
기간
Health education awareness rate
기간: Assessed 1 day before discharge

A self-developed questionnaire on health education awareness will be used. The questionnaire covers eight domains: postoperative disease knowledge, diet, precautions for postoperative activity, postoperative medication, catheter- and pain-related education, postoperative wound observation and discharge health education. Each item has three response options (aware, partly aware, and unaware), with "partly aware" and "unaware" both classified as unaware. Health education awareness rates will be calculated for the control and intervention groups using the formula: health education awareness rate = (number of unaware items / total number of items) × 100%.

Assessed 1 day before discharge
Patients' anxiety symptoms
기간: Assessed 1 month after discharge

The Screen for Child Anxiety Related Emotional Disorders (SCARED) is a self-report instrument for children and adolescents that assesses anxiety disorders across five factors: somatic/panic, generalized anxiety, separation anxiety, social phobia and school phobia. It comprises 41 items, each rated on a three-point scale from 0 to 2 (0: not true; 1: somewhat true; 2: very true). Higher scores indicate more severe anxiety.

Assessed 1 month after discharge
Caregivers' anxiety symptoms
기간: Assessed 1 month after discharge

SAS is used to assess the subjective experience of anxiety and consists of 20 items, each scored on a four-point scale. Five items are positively worded (items 5, 9, 13, 17 and 19), and 15 items are negatively worded (all remaining items). Family members of patients are assessed using the SAS: scores <50 indicate no anxiety, 50-59 mild anxiety, 60-69 moderate anxiety and >69 severe anxiety. Higher scores denote greater anxiety severity. In this study, the SAS is used to evaluate anxiety in patients aged 16 years or older and their caregivers.

Assessed 1 month after discharge
Patient follow-up rate
기간: Assessed at 1 and 3 months after discharge

The follow-up rates of patients in the control and intervention groups at 1 and 3 months after discharge were calculated as: patient follow-up rate = (number of patients who actually participated in follow-up / total number of patients scheduled for follow-up) × 100%.

Assessed at 1 and 3 months after discharge
Quality of life of patients
기간: Assessed 1 month after discharge

Quality of life was assessed using the Quality of Life Scale for Patients with Congenital Middle and External Ear Malformation. This scale evaluates three dimensions-physical functioning, psychological status and social relationships-with 18 items in total. Each item is scored on a five-point scale from 0 to 4; higher scores indicate poorer quality of life.

Assessed 1 month after discharge
Patient satisfaction
기간: Assessed 1 month after discharge

Evaluated using a self-designed satisfaction questionnaire comprising 15 items across five domains: consultation process and environment, quality of medical and nursing services, attitude of medical and nursing staff, health education and use of the information platform. Each item is rated on a three-point Likert scale (3 = satisfied, 2 = basically satisfied, 1 = dissatisfied), yielding a total score of 15-45. The sum of item scores represents overall satisfaction, with higher scores indicating greater patient satisfaction.

Assessed 1 month after discharge

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 1일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2027년 8월 31일

연구 등록 날짜

최초 제출

2026년 9월 23일

QC 기준을 충족하는 최초 제출

2026년 9월 23일

처음 게시됨 (실제)

2026년 9월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 23일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Case management for microtia

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared with external researchers due to patient privacy protection and institutional data policy. Aggregated study results will be reported in publications.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .