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Effectiveness of Using Interactive Consulting System to Enhance Informed Choice

Primary Purpose

Age-related Cataract

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
An interactive chatbot for patient decision aid
Senior ophthalmologists
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Age-related Cataract

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Individuals aged 50-80 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.

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interactive chatbot

Senior ophthalmologists

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 23, 2020
Last Updated
October 11, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04246346
Brief Title
Effectiveness of Using Interactive Consulting System to Enhance Informed Choice
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cataract

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interactive chatbot
Arm Type
Experimental
Arm Description
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.
Arm Title
Senior ophthalmologists
Arm Type
Active Comparator
Arm Description
Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.
Intervention Type
Other
Intervention Name(s)
An interactive chatbot for patient decision aid
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Senior ophthalmologists
Intervention Description
Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
2 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingfeng Zheng, MD, PhD
Phone
+8613922286455
Email
zhyfeng@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingfeng Zheng, MD, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingfeng Zheng, M.D, Ph.D
Phone
+8613922286455
Email
zhyfeng@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified will be shared after the study being published.
IPD Sharing Time Frame
The data will be available upon request after the study being accepted by peer-reviewed journal and published online.
IPD Sharing Access Criteria
The data will be available upon request. Requestors will be asked to sign data sharing agreements.

Learn more about this trial

Effectiveness of Using Interactive Consulting System to Enhance Informed Choice

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