ChiCTR2600118883 版本V1.0 版本创建时间2026/02/12 09:30:30 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600118883 

最近更新日期：

Date of Last Refreshed on：

2026-02-12 09:30:22 

注册时间：

Date of Registration：

2026-02-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于生态瞬时评估与干预的垂体腺瘤患者认知障碍管理平台构建与初步应用

Public title：

Development and Preliminary Application of an Ecological Momentary Assessment and Intervention–Based Cognitive Impairment Management Platform for Patients With Pituitary Adenoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于生态瞬时评估与干预的垂体腺瘤患者认知障碍管理平台构建与初步应用

Scientific title：

Development and Preliminary Application of an Ecological Momentary Assessment and Intervention–Based Cognitive Impairment Management Platform for Patients With Pituitary Adenoma

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

宋蓓蓓 

研究负责人：

宋蓓蓓 

Applicant：

Beibei Song 

Study leader：

Beibei Song 

申请注册联系人电话：

Applicant telephone：

+86 136 4569 7867

研究负责人电话：

Study leader's telephone：

+86 136 4569 7867

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

songbeibeiayfy@163.com

研究负责人电子邮件：

Study leader's E-mail：

songbeibeiayfy@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

安徽省合肥市绩溪路210号安医家属区25栋501

研究负责人通讯地址：

安徽省合肥市绩溪路210号安医家属区25栋501

Applicant address：

Room 501, Building 25, Anyi Residential Community, No. 210 Jixi Road, Hefei, Anhui Province, China

Study leader's address：

Room 501, Building 25, Anyi Residential Community, No. 210 Jixi Road, Hefei, Anhui Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

安徽医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Anhui Medical University

研究负责人所在单位：

安徽医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Anhui Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

安医一附院伦审一PJ 2024-13-71

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

安徽医科大学第一附属医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of The First Affiliated Hospital of Anhui Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-01-24 00:00:00

伦理委员会联系人：

陈奕豪

Contact Name of the ethic committee：

Yihao Chen

伦理委员会联系地址：

安徽省合肥市绩溪路210号

Contact Address of the ethic committee：

No. 210 Jixi Road, Hefei, Anhui Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 150 5517 3128

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

安徽医科大学第一附属医院神经外科

Primary sponsor：

Department of Neurosurgery, The First Affiliated Hospital of Anhui Medical University

研究实施负责（组长）单位地址：

安徽省合肥市绩溪路210号

Primary sponsor's address：

No. 210 Jixi Road, Hefei, Anhui Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽省

市(区县)：

合肥市

Country：

China

Province：

Anhui Province

City：

Hefei

单位(医院)：

安徽医科大学第一附属医院

具体地址：

安徽省合肥市绩溪路210号

Institution
hospital：

The First Affiliated Hospital of Anhui Medical University

Address：

No. 210 Jixi Road, Hefei, Anhui Province, China

经费或物资来源：

安徽省转化医学研究院护理学联合专项课题（项目编号：2024zhyx-hI-B26）。

Source(s) of funding：

Nursing Project of Anhui Institute of Translational Medicine (No. 2024zhyx-hI-B26)

Target disease：

Cognitive impairment in patients with pituitary adenoma

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

本研究旨在以微信小程序作为载体，构建基于生态瞬时评估与干预的垂体腺瘤患者认知障碍管理平台，实现实时监测和即时反馈机制，以改善垂体腺瘤患者的认知功能，提高整体生活质量。 验证该管理平台的可行性和有效性，进行初步应用验证其在实际护理中的效果和实用性，并根据试验结果进一步优化干预方案。为垂体腺瘤患者提供更加有效的护理支持。  

Objectives of Study：

This study aims to develop a cognitive impairment management platform for patients with pituitary adenoma based on ecological momentary assessment (EMA) and ecological momentary intervention (EMI), delivered via a WeChat mini program. The platform is designed to achieve real-time monitoring and instant feedback mechanisms to improve patients’ cognitive function and enhance their overall quality of life. The study seeks to evaluate the feasibility and effectiveness of the platform through preliminary application in clinical practice, verifying its practical utility in nursing care. Based on the findings, the intervention program will be further optimized to provide more effective nursing support for patients with pituitary adenoma.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.经影像学或病理学确诊的垂体腺瘤患者。2.年龄在18至65岁之间，无其他严重的躯体疾病或显著的神经认知功能障碍。3.具备基本的沟通能力，能够有效理解并使用微信小程序进行干预和评估。4.文化水平达到小学及以上学历，确保患者能够阅读、理解小程序中的评估内容及干预指令。5.术前完成基线神经认知功能评估，并且能够配合研究的各项评估和干预措施。6.具备使用智能手机的基本技能，能够独立操作小程序或在家属协助下使用。7.自愿参与本研究并签署知情同意书。

Inclusion criteria

1.Patients with pituitary adenoma confirmed by imaging or pathological diagnosis. 2.Aged 18–65 years, with no other severe physical illness or marked neurocognitive disorder. 3.Able to communicate effectively and to understand and use the WeChat mini-program for intervention and assessment. 4.Education level of primary school or above, ensuring the ability to read and comprehend the assessment content and intervention instructions in the mini-program. 5.Baseline neurocognitive assessment completed preoperatively, and able to comply with all study evaluations and interventions. 6.Possesses basic smartphone skills, able to operate the mini-program independently or with assistance from family members. 7.Voluntarily agrees to participate and signs the informed consent form.

排除标准：

1.既往有其他神经系统疾病或严重精神疾病史的患者。2.术前已存在严重神经认知功能障碍或心理疾病，无法进行有效评估和干预的患者。3.有严重听力或视力障碍，影响问卷和评估工具使用的患者。4.参加其他干预性研究，可能干扰本研究结果的患者。

Exclusion criteria：

1.Patients with a history of other neurological disorders or severe psychiatric illness. 2.Patients with preoperative severe neurocognitive impairment or psychiatric conditions that preclude effective assessment or intervention. 3.Patients with significant hearing or visual impairment that interferes with the use of questionnaires and assessment tools. 4.Patients participating in other interventional studies that may confound the outcomes of this study.

研究实施时间：

Study execute time：

从 From 2025-05-01 00:00:00至 To 2027-01-23 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-05-01 00:00:00 至 To 2027-01-23 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

20

Group：

Intervention group

Sample size：

干预措施：

使用基于生态瞬时评估和干预的微信小程序作为干预措施。

干预措施代码：

Intervention：

Use a WeChat mini program based on ecological momentary assessment and intervention (EMA/EMI) as the intervention.

Intervention code：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

常规护理

干预措施代码：

Intervention：

Routine care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

  

Country：

China 

Province：

Anhui Province 

City：

 

单位(医院)：

安徽医科大学第一附属医院 

单位级别：

三级甲等 

Institution
hospital：

The First Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A,

测量指标：

Outcomes：

指标中文名：

蒙特利尔认知

指标类型：

主要指标

Outcome：

Montreal Cognitive, MoCA

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

简易精神状态

指标类型：

主要指标

Outcome：

MiniMental State, MMSE

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

公开日期：不迟于 2027-03-31（数据库锁定后，且主要结果发表后 6 个月内公开）。 方式与平台（仅国内平台）：采取分级共享。 开放共享材料：在科学数据银行 ScienceDB（https://www.scidb.cn）公开数据字典/变量说明、代码本、统计分析脚本等，并生成永久标识（DOI/CSTR），发布后回填 DOI/链接。 原始行级数据（受控访问/EDC）：去标识化个体原始数据存放于 ResMan 临床研究公共管理平台/EDC（https://www.medresman.org），采用申请制共享；申请者提交用途说明、伦理批件与数据使用协议（DUA），经 PI 与本院伦理审核通过后提供一次性加密下载或受控访问。 联系人：宋蓓蓓（songbeibeiayfy@163.com）。 合规与期限：数据去标识化处理，仅限非商业学术用途；保存期限≥5年；版本化更新并记录变更说明。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Public release date: No later than 2027-03-31 (after database lock and within 6 months following publication of the primary results). Approach and platforms (domestic platforms only): A tiered data-sharing model will be adopted. Open materials: Data dictionary/variable descriptions, codebook, statistical analysis scripts, and related materials will be made publicly available on the Science Data Bank (ScienceDB; [https://www.scidb.cn](https://www.scidb.cn)). A persistent identifier (DOI/CSTR) will be generated, and the DOI/link will be completed once available. Row-level raw data (controlled access/EDC): De-identified individual-level raw data will be stored in the ResMan Clinical Research Public Management Platform/EDC ([https://www.medresman.org](https://www.medresman.org)) and shared via an application-based mechanism. Applicants must submit a statement of intended use, ethics approval documentation, and a Data Use Agreement (DUA). Access will be granted upon approval by the PI and the hospital ethics committee, and provided via a one-time encrypted download link or controlled access. Contact: Beibei Song ([songbeibeiayfy@163.com](mailto:songbeibeiayfy@163.com)). Compliance and retention: Data will be de-identified and limited to non-commercial academic use; retention period ≥ 5 years; versioned updates will be maintained with documented change logs.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

总体原则 本研究采用“病例记录表（CRF）＋ 电子数据采集与管理系统（EDC）”模式开展数据管理。所有研究数据遵循最小必要、去标识化、可追溯原则，个人识别信息与研究数据分表、分权限保存；数据的创建、修改、核查全程留有审计追踪与时间戳。EDC 选用 ResMan 临床试验公共管理平台（中国临床试验注册中心推荐的基于互联网的 EDC/公共管理平台）。 一）CRF（Case Report Form） 依据研究方案与变量字典统一设计 CRF（纸质 CRF 与 eCRF 等价），涵盖：筛选/入组、一般资料、影像/病理与激素信息、干预执行日志、主要/次要结局（如 MoCA 于术后 1 个月、3 个月）、不良事件（AE/SAE）、失访/退出等模块。每名受试者赋予唯一受试者识别码（仅含编码，不含直接识别信息）；实名联系信息仅存于受控联系表。CRF 由受训合格的研究人员填写，当日完成双人核对/电子签名；任何更改必须记录修改原因并保留原值（audit trail）。如使用纸质 CRF，数据录入 EDC 采用双录入或单录入＋系统校验以确保一致性。 二）EDC（ResMan） EDC 使用 ResMan 临床试验公共管理平台（https://www.medresman.org.cn），启用角色与权限控制（PI/数据管理员/研究护士/统计员）、逻辑与范围校验、跨表一致性检查、质疑（Query）管理、版本管理与电子签名、数据库冻结/解冻/锁定**等功能；所有操作留痕可追溯。研究为非随机设计，中央随机化模块未启用；如后续升级为随机试验，可在 ResMan 中开启中央随机化与分配隐藏模块。数据传输与存储采取加密与备份措施（每日增量、每周全量），数据库锁定（DB lock）由 PI 与数据管理员共同执行。 三）小程序数据对接与质控 “e护心灵航标”小程序产生的评估/训练日志及依从性指标按变量映射表定期汇入 EDC（批量 CSV/接口同步均可），并触发字段级校验（缺失、越界、逻辑冲突）与跨表核对（如时间点与访视窗口匹配）。数据疑问单（Query）由数据管理员发起，责任研究者在规定时限内回应并关闭。每月执行一次**数据核查清单（DVP）与偏差复核，必要时召开数据审核会议，并形成书面记录归档。 四）隐私保护与合规 EDC 不录入直接识别信息（姓名、身份证号、手机号等）；识别信息仅存院内受控联系表。对外提供行级原始数据时，严格按去标识化与最小必要原则，经 PI 与本机构伦理批准后方可受控提供；相关做法与时间节点遵循 ChiCTR 对原始数据共享的要求。 五）原始数据共享（与登记“共享方式”字段一致） 研究完成并发表主要结果后 ≤6 个月，在 ResMan 公共管理平台提交原始数据（IPD）共享：平台支持在线浏览（默认不开放直接下载），如需下载须联系研究者并在伦理批准/数据使用协议（DUA）框架内受控提供；亦可同步在注册条目中更新共享计划与链接/DOI。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data Collection and Management Overall Principles This study adopts a dual-track approach of Case Report Forms (CRF) plus an Electronic Data Capture (EDC) system. All study data follow the principles of data minimization, de-identification, and traceability. Personally identifiable information (PII) is stored separately from research data with role-based access controls; creation, modification, and verification of data are fully recorded with audit trails and timestamps. The EDC selected is the ResMan Clinical Trial Public Management Platform (an internet-based EDC/public management platform recommended by the China Clinical Trial Registry, ChiCTR). 1.CRF (Case Report Form) CRFs are designed in accordance with the protocol and data dictionary (paper CRFs are equivalent to eCRFs), covering: screening/enrollment, demographics/general information, imaging/pathology and hormone data, intervention execution logs, primary/secondary outcomes (e.g., MoCA at 1 month and 3 months post-operation), adverse events (AE/SAE), and loss to follow-up/withdrawal. Each participant is assigned a unique subject identification code (code only, without direct identifiers); identifiable contact information is kept only in a controlled contact sheet. CRFs are completed by trained study personnel with same-day double checking/e-signature. Any change must document the reason for change and retain the original value (audit trail). If paper CRFs are used, entry into the EDC is performed via double data entry or single entry plus system validation to ensure consistency. 2.EDC (ResMan) The EDC is the ResMan Clinical Trial Public Management Platform (https://www.medresman.org.cn), with role- and permission-based access control (PI/data manager/study nurse/statistician), logic and range checks, cross-form consistency checks, query management, version control and e-signatures, and database freeze/defrost/lock functions; all operations are traceable. The current study is non-randomized, so the central randomization module is not enabled. If upgraded to a randomized trial, ResMan’s central randomization and allocation-concealment modules can be activated. Data transmission and storage are protected by encryption and backups (daily incremental, weekly full). Database lock (DB lock) is jointly executed by the PI and the data manager. 3.Mini-program Data Interface and Quality Control Data generated by the "e" WeChat mini-program—assessment/training logs and adherence indicators—are imported into the EDC on a scheduled basis per a variable-mapping table (batch CSV import or API synchronization). Imports trigger field-level validations (missing values, out-of-range entries, logical conflicts) and cross-form reconciliation (e.g., time points vs. visit windows). Data queries are initiated by the data manager and must be responded to and closed by the responsible investigator within specified time limits. A monthly Data Verification Plan (DVP) review and deviation check are performed; data review meetings are convened as needed and minutes are archived. 4.Privacy Protection and Compliance No direct identifiers (e.g., name, national ID number, phone number) are entered into the EDC; such identifiers are stored only in the controlled institutional contact sheet. Provision of row-level individual data to external parties strictly follows de-identification and data-minimization principles and is permitted only under controlled access with prior approval by the PI and the institutional IRB. Timing and procedures align with ChiCTR requirements for raw-data sharing. 5.Sharing of Raw Data (aligned with the registry "mode of sharing" field) Within<=6 months after study completion and publication of the primary results, individual participant data (IPD) will be shared via the ResMan Clinical Trial Public Management Platform. By default, the platform supports online viewing (direct downloads are not open by default); if a download is requested, applicants should contact the investigators and—under IRB approval and a Data Use Agreement (DUA)—controlled access may be granted. The registry entry will be updated in parallel with the data-sharing plan and the link/DOI.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-02-12 09:30:22