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Effectiveness of Using Interactive Consulting System to Enhance Informed Choice

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04246346
Enrollment
660
Registered
2020-01-29
Start date
2023-09-01
Completion date
2023-12-31
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cataract

Brief 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.

Detailed 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.

Interventions

OTHERAn 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.

OTHERSenior ophthalmologists

Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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)2 weeks post interventionInformed 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)

Countries

China

Contacts

Primary ContactYingfeng Zheng, MD, PhD
zhyfeng@mail.sysu.edu.cn+8613922286455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026