search
Back to results

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

Primary Purpose

Benign Prostate Enlargement, Lower Urinary Tract Symptoms, Erectile Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Chatbot
Sponsored by
Cheng-Hsin General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Benign Prostate Enlargement focused on measuring Lower urinary tract symptoms, Erectile dysfunction, Men's Health, Chatbot, Chronic disease self-management, Decision self-efficacy

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cheng Hsin General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chatbot-aid intervention

Control group

Arm Description

Chatbot-aid intervention group

Written routine nursing health education guidance intervention.

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

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".

Full Information

First Posted
March 5, 2023
Last Updated
March 9, 2023
Sponsor
Cheng-Hsin General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05765331
Brief Title
The Impact of Chatbot-aid on Promoting Self-management of Men's Health in the Post COVID-19 Era
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cheng-Hsin General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Enlargement, Lower Urinary Tract Symptoms, Erectile Dysfunction
Keywords
Lower urinary tract symptoms, Erectile dysfunction, Men's Health, Chatbot, Chronic disease self-management, Decision self-efficacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chatbot-aid intervention
Arm Type
Experimental
Arm Description
Chatbot-aid intervention group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Written routine nursing health education guidance intervention.
Intervention Type
Device
Intervention Name(s)
Chatbot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Men's Health Knowledge Score
Description
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.
Time Frame
Baseline and 2-4 weeks after intervention.
Title
Partners in Health Scale
Description
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).
Time Frame
Baseline and 2-4 weeks after intervention.
Title
Decision Self-Efficacy Scale
Description
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).
Time Frame
Baseline and 2-4 weeks after intervention.
Secondary Outcome Measure Information:
Title
The evaluation of chatbot satisfaction.
Description
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".
Time Frame
2-4 weeks after intervention.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang-Kuo Chen, MD, PhD
Phone
+886-2-2826-4400
Ext
8007
Email
kkchen@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Pei Chiu, RN, MS
Phone
+886-9-87677-711
Ext
3131
Email
kyoto.sakura0106@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang-Kuo Chen, MD, PhD
Organizational Affiliation
Cheng-Hsin General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cheng Hsin General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuang-Kuo Chen, MD, PhD
Phone
+886-2-2826-4400
Ext
8007
Email
kkchen@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Pei-Pei Chiu, RN, MS
Phone
+886-9-87677-711
Email
kyoto.sakura0106@gmail.com
First Name & Middle Initial & Last Name & Degree
Pei-Ying Yang, B.S
First Name & Middle Initial & Last Name & Degree
Shuang-Feng Yang, B.S
First Name & Middle Initial & Last Name & Degree
Pei-Pei Chiu, RN, MS

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
33685877
Citation
Albarqouni L, Sanders S, Clark J, Tikkinen KAO, Glasziou P. Self-Management for Men With Lower Urinary Tract Symptoms: A Systematic Review and Meta-Analysis. Ann Fam Med. 2021 Mar-Apr;19(2):157-167. doi: 10.1370/afm.2609.
Results Reference
background
PubMed Identifier
1279218
Citation
Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
Results Reference
background
PubMed Identifier
31107577
Citation
Blanker MH, Brandenbarg P, Slijkhuis BGC, Steffens MG, van Balken MR, Jellema P. Development of an online personalized self-management intervention for men with uncomplicated LUTS. Neurourol Urodyn. 2019 Aug;38(6):1685-1691. doi: 10.1002/nau.24040. Epub 2019 May 20.
Results Reference
background
PubMed Identifier
32547642
Citation
Bortnick E, Brown C, Simma-Chiang V, Kaplan SA. Modern best practice in the management of benign prostatic hyperplasia in the elderly. Ther Adv Urol. 2020 May 27;12:1756287220929486. doi: 10.1177/1756287220929486. eCollection 2020 Jan-Dec.
Results Reference
background
PubMed Identifier
29392976
Citation
Calogero AE, Burgio G, Condorelli RA, Cannarella R, La Vignera S. Epidemiology and risk factors of lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction. Aging Male. 2019 Mar;22(1):12-19. doi: 10.1080/13685538.2018.1434772. Epub 2018 Feb 2.
Results Reference
background
PubMed Identifier
31474582
Citation
Capogrosso P, Boeri L, Pozzi E, Ventimiglia E, Schifano N, Abbate C, Matloob R, Deho F, Montorsi F, Salonia A. Is It Compulsory to Investigate for Erectile Dysfunction in Patients Presenting for Low Urinary Tract Symptoms? Eur Urol Focus. 2021 Jan;7(1):172-177. doi: 10.1016/j.euf.2019.08.007. Epub 2019 Aug 30.
Results Reference
background
PubMed Identifier
28687936
Citation
Chapple C, Castro-Diaz D, Chuang YC, Lee KS, Liao L, Liu SP, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of Lower Urinary Tract Symptoms in China, Taiwan, and South Korea: Results from a Cross-Sectional, Population-Based Study. Adv Ther. 2017 Aug;34(8):1953-1965. doi: 10.1007/s12325-017-0577-9. Epub 2017 Jul 7.
Results Reference
background
PubMed Identifier
30140322
Citation
Dumbraveanu I, Ceban E, Banov P. Lower urinary tract symptoms and erectile dysfunction in men from the Republic of Moldova. J Med Life. 2018 Apr-Jun;11(2):153-159.
Results Reference
background
PubMed Identifier
8254833
Citation
Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
Results Reference
background
PubMed Identifier
32994064
Citation
Ghose A, Roy S, Vasdev N, Olsburgh J, Dasgupta P. The Emerging Role of Artificial Intelligence in the Fight Against COVID-19. Eur Urol. 2020 Dec;78(6):775-776. doi: 10.1016/j.eururo.2020.09.031. Epub 2020 Sep 17.
Results Reference
background
PubMed Identifier
31019961
Citation
Goldenthal SB, Portney D, Steppe E, Ghani K, Ellimoottil C. Assessing the feasibility of a chatbot after ureteroscopy. Mhealth. 2019 Mar 15;5:8. doi: 10.21037/mhealth.2019.03.01. eCollection 2019.
Results Reference
background
PubMed Identifier
28734864
Citation
Griffith JW, Messersmith EE, Gillespie BW, Wiseman JB, Flynn KE, Kirkali Z, Kusek JW, Bavendam T, Cella D, Kreder KJ, Nero JJ, Corona ME, Bradley CS, Kenton KS, Helfand BT, Merion RM, Weinfurt KP; LURN Study Group. Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study. J Urol. 2018 Feb;199(2):528-535. doi: 10.1016/j.juro.2017.07.067. Epub 2017 Jul 20.
Results Reference
background
PubMed Identifier
32898686
Citation
Li JO, Liu H, Ting DSJ, Jeon S, Chan RVP, Kim JE, Sim DA, Thomas PBM, Lin H, Chen Y, Sakomoto T, Loewenstein A, Lam DSC, Pasquale LR, Wong TY, Lam LA, Ting DSW. Digital technology, tele-medicine and artificial intelligence in ophthalmology: A global perspective. Prog Retin Eye Res. 2021 May;82:100900. doi: 10.1016/j.preteyeres.2020.100900. Epub 2020 Sep 6.
Results Reference
background
PubMed Identifier
31467682
Citation
Nadarzynski T, Miles O, Cowie A, Ridge D. Acceptability of artificial intelligence (AI)-led chatbot services in healthcare: A mixed-methods study. Digit Health. 2019 Aug 21;5:2055207619871808. doi: 10.1177/2055207619871808. eCollection 2019 Jan-Dec.
Results Reference
background
PubMed Identifier
34782055
Citation
Nadarzynski T, Puentes V, Pawlak I, Mendes T, Montgomery I, Bayley J, Ridge D. Barriers and facilitators to engagement with artificial intelligence (AI)-based chatbots for sexual and reproductive health advice: a qualitative analysis. Sex Health. 2021 Nov;18(5):385-393. doi: 10.1071/SH21123.
Results Reference
background
PubMed Identifier
9187685
Citation
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
Results Reference
background
PubMed Identifier
33212360
Citation
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.
Results Reference
background
Links:
URL
http://decisionaid.ohri.ca/docs/develop/user_manuals/UM_decision_selfefficacy.pdf
Description
O'Connor, A. M. (2002). User manual-decisional self-efficacy scale. Ottawa: Ottawa Hospital Research Institute;1995 [modified 2002]

Learn more about this trial

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

We'll reach out to this number within 24 hrs