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Case Management for Microtia

2026年9月23日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

188

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Shanghai、中国、201112
        • 募集
        • EYE & ENT Hospital, Fudan University
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6年~40年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:非ランダム化
  • 介入モデル:順次割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし: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.

実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of postoperative complications after ear reconstruction
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Health education awareness rate
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月1日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2027年8月31日

試験登録日

最初に提出

2026年9月23日

QC基準を満たした最初の提出物

2026年9月23日

最初の投稿 (実際)

2026年9月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月29日

QC基準を満たした最後の更新が送信されました

2026年9月23日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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