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

March 9, 2023 updated by: Cheng-Hsin General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Cheng Hsin General Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pei-Ying Yang, B.S
        • Sub-Investigator:
          • Shuang-Feng Yang, B.S
        • Sub-Investigator:
          • Pei-Pei Chiu, RN, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chatbot-aid intervention
Chatbot-aid intervention group
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.
No Intervention: Control group
Written routine nursing health education guidance intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Men's Health Knowledge Score
Time Frame: 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.
Baseline and 2-4 weeks after intervention.
Partners in Health Scale
Time Frame: 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).
Baseline and 2-4 weeks after intervention.
Decision Self-Efficacy Scale
Time Frame: 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).
Baseline and 2-4 weeks after intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of chatbot satisfaction.
Time Frame: 2-4 weeks after intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cheng-Hsin General Hospital

Investigators

  • Principal Investigator: Kuang-Kuo Chen, MD, PhD, Cheng-Hsin general hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (988)111A-66-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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