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临床试验/NCT05765331
NCT05765331招募中不适用

Evaluating the Effectiveness of Chatbot-Based Intervention on Enhancing Self-management and Decision Self-efficacy Among Men Having Lower Urinary Tract Symptoms With or Without Erectile Dysfunction in the Post COVID-19 Era

Cheng-Hsin General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月2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
100
试验地点
1
主要终点
Partners in Health Scale

研究概览

简要总结

The AI chatbot as an artificial intelligence technology provides disease information and health care through digital assistance. However, the effectiveness of chatbot in promoting men's health in the field of urology needs further research to evaluate its actual results. The purpose of this study is to explore the impact of AI chatbot-aid intervention on enhancing self-management, and decision self-efficacy among men with lower urinary tract symptoms (LUTS) due to an enlarged prostate, and with or without erectile dysfunction (ED) in the post COVID-19 era.

详细描述

  1. Background and objectives :

After the age of 50 years, men's health may be impacted by various disorders such as lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Due to a lack of understanding and awareness, patients often fail to recognize early signs and are not compliant with medical advice. As they are hesitant to discuss these issues related to urination and erectile functions, they avoid seeking medical help, especially due to the restrictions and concerns brought by the COVID-19 pandemic. Consequently, worsening symptoms can adversely affect their quality of life and dignity. Studies have found that providing men with self-management health programs results in better symptom management and medical decisions. Therefore, work is underway to develop artificial intelligence (AI) platforms to allow men to manage their health before consulting a doctor. Chatbots are used for various medical decisions and healthcare management, and can now provide men with various healthcare information to help improve the effectiveness of self-care and medical treatments in the post COVID-19 period.

The purpose of this study is to explore the impact of AI chatbot aid intervention on enhancing self-management, and decision self-efficacy among men with lower urinary tract symptoms (LUTS) due to an enlarged prostate, with or without erectile dysfunction (ED) in the post COVID-19 era. 2. Materials and Methods:

2.1. Trial design and ethical approval

This was a 1:1 two groups randomized controlled trial (RCT) with pre- and post-test experimental design. This study was approved by the Institutional Review Board (IRB) of Cheng Hsin General Hospital in Taipei, Taiwan (approval number CHGH-IRB (988)111A-66-2) and participants were provided with informed consent. Both groups had similar demographics. One hundred male patients will be recruited from the Urology outpatient clinic, with 50 patients randomly assigned to the experimental group and 50 patients to the control group.

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 (Participant)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Age between 45 years to 80 years old
  • •Prostate enlargement with lower urinary tract symptoms
  • •Need a mobile phone and willing to download the line chatbot

排除标准

  • •Psychosis

研究组 & 干预措施

Chatbot-aid intervention

Experimental

Chatbot-aid intervention group

干预措施: Chatbot (Device)

Control group

No Intervention

Written routine nursing health education guidance intervention.

结局指标

主要结局

Partners in Health Scale

时间窗: Baseline and 2-4 weeks after intervention.

The Partners in Health (PIH) is a validated,12 items questionnaire scored on a self-rated 9-point Likert scale (range: 0-8; higher scores indicate better self-management).

Decision Self-Efficacy Scale

时间窗: Baseline and 2-4 weeks after intervention.

The 11 items of the Decision Self-Efficacy Scale (DSES) used to assess the self-confidence of participants in their ability to make health decisions, ranged from 0 (not at all confident) to 4 (very confident).

Men's Health Knowledge Score

时间窗: Baseline and 2-4 weeks after intervention.

The 15 items of the Men's Health knowledge score are based on urination, prostate, and erectile dysfunction disorders. A total of 6 domains are to create men's health knowledge, which is used to evaluate the effectiveness of chatbot in promoting men's health knowledge.

次要结局

  • The evaluation of chatbot satisfaction.(2-4 weeks after intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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