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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04246346
Other study ID # 2020KYPJ003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source Sun Yat-sen University
Contact Yingfeng Zheng, MD, PhD
Phone +8613922286455
Email zhyfeng@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses.


Description:

Cataract surgery is the only way to treat age-related cataract. For patients at early or moderate stages, cataract surgery is an elective surgery without objective indications. Therefore the patients are uaually not aware whether they should receive the surgery. The number of trained and qualified ophthalmologists are limited in China and lots of patients cannot have detailed consultation with ophthalmologists. As a result, many patients still have doubts about whether they should receive cataract surgery or not. In this study, we aim to assess the effectiveness of an interactive chatbot based on large language models versus senior ophthalmologists to enhance informed decisions made by cataract patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 660
Est. completion date December 31, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria: 1. Individuals aged 45-80 years who have been resident in the selected study district for more than six months; 2. A definite diagnosis of age-related cataract; 3. Having not received cataract surgery; 4. Willing to participate the study and provide informed consent. Exclusion Criteria: 1. Bilateral blindness (presenting distance visual acuity worse than 3/60); 2. Having ocular, hearing or mental disorders precluding reading or telephone interview; 3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery; 4. Having cataract surgery contraindication.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
An interactive chatbot for patient decision aid
A chatbot embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.
Senior ophthalmologists
Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.

Locations

Country Name City State
China Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Informed choice about cataract surgery (the proportion of participants who make an informed choice,which is defined as a good knowledge score and an intention that is consistent with their attitude score) Informed choice is an aggregated measure of multiple measurements, including knowledge (a 12-item questionnaire that assesses conceptual (items 1-10) and numerical (items 11-12) knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses) 2 weeks post intervention
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