NCT04246346

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
3.6 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

January 23, 2020

Last Update Submit

October 25, 2023

Conditions

Age-related Cataract

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Interactive chatbot

EXPERIMENTAL

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.

Other: An interactive chatbot for patient decision aid

Senior ophthalmologists

ACTIVE COMPARATOR

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

Other: Senior ophthalmologists

Interventions

An interactive chatbot for patient decision aidOTHER

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.

Interactive chatbot
Senior ophthalmologistsOTHER

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

Senior ophthalmologists

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 45-80 years who have been resident in the selected study district for more than six months;
  • A definite diagnosis of age-related cataract;
  • Having not received cataract surgery;
  • Willing to participate the study and provide informed consent.

You may not qualify if:

  • Bilateral blindness (presenting distance visual acuity worse than 3/60);
  • Having ocular, hearing or mental disorders precluding reading or telephone interview;
  • Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
  • Having cataract surgery contraindication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Study Officials

  • Yingfeng Zheng, MD, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingfeng Zheng, MD, PhD

CONTACT

+8613922286455zhyfeng@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 29, 2020

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Deidentified will be shared after the study being published.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data will be available upon request after the study being accepted by peer-reviewed journal and published online.
Access Criteria
The data will be available upon request. Requestors will be asked to sign data sharing agreements.

Locations

CN(1)