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

NCT05765331 | Unknown DMC

• 1 other identifier: (988)111A-66-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• The evaluation of chatbot satisfaction.

  2-4 weeks after intervention.

Study Arms (2)

Chatbot-aid intervention

EXPERIMENTAL

Chatbot-aid intervention group

Device: Chatbot

Control group

NO INTERVENTION

Written routine nursing health education guidance intervention.

Interventions

Chatbot DEVICE

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.

Chatbot-aid intervention

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychosis

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (17)

• 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.

  PMID: 33685877 BACKGROUND

• 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.

  PMID: 1279218 BACKGROUND

• 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.

  PMID: 31107577 BACKGROUND

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  PMID: 31474582 BACKGROUND

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• 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.

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• 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.

  PMID: 31019961 BACKGROUND

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Related Links

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

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Kuang-Kuo Chen, MD, PhD

  Cheng-Hsin General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Kuo Chen, MD, PhD

CONTACT

+886-2-2826-4400; kkchen@vghtpe.gov.tw

Pei-Pei Chiu, RN, MS

CONTACT

+886-9-87677-711; kyoto.sakura0106@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 13, 2023
• Study Start: January 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)