Effectiveness of Using Interactive Consulting System to Enhance Informed Choice

Age-related Cataract Clinical Trial

Official title:

Effectiveness of Using Interactive Consulting System Based on Large Language Model to Enhance Informed Choice of Cataract Patients: a Non-inferiority Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246346
• Other study ID #: 2020KYPJ003
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

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