跳至主要内容
临床试验/NCT06800482
NCT06800482招募中不适用

A Randomized Controlled Study of Online Outpatient Follow-up in Patients with Papillary Thyroid Cancer After Surgery

West China Hospital1 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2024年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
388
试验地点
1
主要终点
The adherence to outpatient procedures

研究概览

简要总结

The randomized, actively controlled, non-inferiority trial is scheduled to begin in August 2024 and run through August 2026. Inclusion criteria: (1) has undergone microwave ablation of thyroid or thyroidectomy (including endoscopy and opening) at the Department of Thyroid Surgery of West China Hospital of Sichuan University, (2) is between 18 and 90 years old, (3) speaks Chinese, (4) has the email address and operational ability required to complete the visit, (5) does not have a mental illness or take psychotropic drugs, (6) Voluntarily participate in clinical trials and sign informed consent. Exclusion criteria: (1) postoperative hospital stay more than 3 days; (2) Inability to complete an online visit (no access to the device or the Internet); (3) High risk of postoperative complications (recurrent laryngeal nerve injury, etc.); (4) Inability to participate due to a medical condition, laboratory test results, or physical disability (as determined by the principal investigator or surgeon).

The online outpatient follow-up was completed by thyroid surgeons of West China Hospital. Informed consent signed with a voluntary participant after a research team member contacts the patient and introduces the patient to the study. The investigators who contacted, enrolled, and randomly assigned patients included the principal investigator, the study coordinator, and the research assistant who had been specially trained in the study.

According to the agreement, the participants randomly assigned to online visits will cross over with offline visits and withdraw from the clinical trial if :(1) unresolved technical issues, (2) inability to perform a full evaluation, (3) need/request prescription painkillers, and (4) additional care recommended by a physician. Other cross-cutting reasons include patient requests and scheduling conflicts.

The information department of WestChina hospital obtained online and offline participants' demographic data and comorbidities, related information of chief complaint (including time of illness, information of last visit, drugs being used, contents of consultation, disease symptoms, conclusions of consultation, etc.), and online and offline outpatient information (including application time, reception time, patient satisfaction, etc.). Whether to prescribe medicine, whether to prescribe examination/admission certificate, outpatient cost, number of questions, number of return visits, etc.) Employment, living conditions and the highest education level were obtained through the questionnaire survey at the time of enrollment, and the information about participant experience and satisfaction was obtained through the questionnaire survey after follow-up. The investigators recorded the diagnosis and treatment details of the patients at three online/offline follow-up visits at 1, 3, and 6 months after surgery. The investigators reviewed the electronic medical record 30 days after the last follow-up to monitor for adverse events. Participants were surveyed by email 30 days after the last follow-up to assess adverse events, including readmissions. If the survey is not answered within a week, an electronic reminder is sent and two attempts are made to contact the participants by phone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •clinical diagnosis of papillary thyroid cancer
  • •has underwent thyroid surgery (including endoscopic and open thyroid surgery)
  • •18 to 90 years of age
  • •spoke Chinese
  • •has the ability to use mobile phones and the Internet to complete the visit
  • •voluntarily participate in clinical trials and sign informed consent.

排除标准

  • •postoperative hospital stay more than 5 days
  • •inability to complete an online visit (no access to the device or the Internet
  • •high risk of postoperative complications (recurrent laryngeal nerve injury, etc.)
  • •unable to participate due to comorbidities, laboratory test results or physical disability
  • •pregnancy
  • •has mental illness or take psychotropic drugs, and were not able to perform the surgery

研究组 & 干预措施

Using Huayitong APP in participants with papillary thyroid cancer

Active Comparator

Post-operative follow-up was performed using Huayitong APP

干预措施: online outpatient follow-up (Behavioral)

standard offline outpatient follow-up in patients with papillary thyroid cancer

No Intervention

Participants were followed up in traditional offline outpatient clinics

结局指标

主要结局

The adherence to outpatient procedures

时间窗: From enrollment to the end of follow-up at 12 months

At 12 months after the operation, the participants' medical information is extracted through the electronic recording system of Huatong APP to determine whether the participants complied with the random group for postoperative follow-up. The data were extracted by the Information Department of West China Hospital.

次要结局

  • General life quality of participants(From enrollment to the end of follow-up at 12 months)

研究者

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

Xinyi Wang

Principal Investigator

Sichuan University

研究点 (1)

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