The Impact of Chatbot-aid on Promoting Self-management of Men's Health in the Post COVID-19 Era

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765331
• Other study ID #: (988)111A-66-2
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Cheng-Hsin General Hospital
• Contact: Kuang-Kuo Chen, MD, PhD
• Phone: +886-2-2826-4400
• Email: kkchen[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

2.2 Participants

Patients diagnosed with health-related diseases by urologists were included in this study. The conditions were as follows:(1) male, (2) age between 45-80 years old, (3) prostate enlargement with lower urinary tract symptoms, (4) need a mobile phone and willing to download the line chatbot. The exclusion criterion was a history of psychosis.

2.3 Intervention

The study uses a chatbot in collaboration with the Taiwan Urological Association (TUA) and the Taiwan Continence Society (TCS), which is deployed on the line app for mobile devices. The chatbot uses an AI model integrated with the line developer platform to predict risks for men's health conditions such as urinary symptoms and erectile dysfunction. Patients can access the chatbot for free by scanning a QR code. It provides self-management advice on issues such as prostate enlargement, urinary symptoms, and erectile dysfunction. It also provides patient-centered decision-making aids that support and encourage patients, especially in improving urination and erectile dysfunction.

2.4 Research instruments

The patients in both groups were asked to complete a basic personal information form, as well as several questionnaires including the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), Men's Health knowledge score, Partners in Health (PIH), and Decision Self-Efficacy Scale (DSES) before and 2-4 weeks after receiving the intervention measures. Additional examination data, such as prostate-specific antigen (PSA), uroflowmetry, and prostate sonography, were collected from medical records. A satisfaction questionnaire was also administered to the patients.

2.5 Statistical methods

SPSS was used for statistical analysis, including McNemar's test and independent sample t-test were used to compare and analyze the difference in the knowledge score, self-management, and decision-making self-efficacy between the experimental group and control group before and after the intervention; paired t-test was used to compare individuals before and after receiving intervention measures; Pearson's correlation was used to analyze the relationship among LUTS, knowledge score, self-management, and decision self-efficacy; Finally, multiple regression analysis to analyze the impact of using the chatbot on satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Psychosis

Related Conditions & MeSH terms

• Benign Prostate Enlargement
• Erectile Dysfunction
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Chatbot
The AI chatbot is a kind of artificial intelligence technology that can help increase knowledge and understanding of men's health issues. That interacts with subjects through literal text and provides educational resources, advice, and assistance related to lifestyle changes. The chatbot is a valuable aid to increase men's health by providing information about enlarged prostate with urination problems and erectile dysfunction.

Locations

Country	Name	City	State
Taiwan	Cheng Hsin General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cheng-Hsin General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (17)

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Wang TJ, Chiu PP, Chen KK, Hung LP. Efficacy of a decision support intervention for reducing decisional conflict in patients with elevated serum prostate-specific antigen: A randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101865. doi: 10.1016/j.ejon.2020.101865. Epub 2020 Nov 4. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Men's Health Knowledge Score	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.	Baseline and 2-4 weeks after intervention.
Primary	Partners in Health Scale	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).	Baseline and 2-4 weeks after intervention.
Primary	Decision Self-Efficacy Scale	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).	Baseline and 2-4 weeks after intervention.
Secondary	The evaluation of chatbot satisfaction.	There are 9 questions about the satisfaction level of using the chatbot, with a Likert scale of 1-5, where 1 is "extremely dissatisfied" and 5 is "extremely satisfied".	2-4 weeks after intervention.

External Links

•   O'Connor, A. M. (2002). User manual-decisional self-efficacy scale. Ottawa: Ottawa Hospital Research Institute;1995 [modified 2002]