Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial

December 11, 2023 updated by: Yingfeng Zheng, Sun Yat-sen University
To compare the effectiveness of an interactive mobile chatbot and traditional decision aid booklets to enhance informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate ChatGPT-level responses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, patients are uaually not aware whether they should receive the surgery or not. In clinical practice, traditional Patient Decision Aids (PDA) booklets are used to provide health education to patients. However, PDAs lack real-time interaction with patients, and are unable to answer the new questions raised. Patients still have doubts about whether they should receive cataract surgery or not. In this study, the investigators aim to assess the effectiveness of an interactive Q&A mobile application based on natural language processing technology to enhance informed decisions made by cataract patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
492

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhognshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Individuals aged 50-80, living in the designated research area for more than 6 months;
  2. Primary diagnosis of cataract and have not undergone cataract surgery;
  3. Ownership of a smartphone/tablet capable of using the study app and the ability to smoothly type in chat content
  4. Willing to participate in the research and provide informed content.

Exclusion Criteria

  1. Blindness in both eyes (manifesting as a distant vision less than 3/60);
  2. Eye, hearing, or mental disorders that hinder reading or telephone interviews;
  3. Permanent vision loss due to eye diseases other than cataracts, which cannot be corrected by cataract surgery;
  4. Contraindications for cataract surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interactive Consulting System
The AI system adheres to the AHRQ SHARE approach (https://www.ahrq.gov/health-literacy/professional-training/shared-decision/tools/factsheet.html) for shared decision-making, which involves evaluating healthcare options, weighing pros and cons, and assessing potential risks while allowing patients to express their preferences.
Other: Interactive Consulting System
Potential participants use the Interactive Consulting System on a mobile application with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.
Active Comparator: Traditional decision aid brochure
A traditional patient decision aid brochure that includes provide standard general information, quantitative risk information on the possible outcomes of cataract surgery and value clarification exercise.
Other: A traditional patient decision aid brochure
Potential participants receive a traditional patient decision aid brochure with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 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)
Time Frame: 2 weeks post intervention

Informed choice is an aggregated measure of multiple measurements, including:

  1. Knowledge (a 12-item questionnaire that assesses conceptual knowledge of cataract and cataract surgery). Questions with right answers will earn 1 point otherwise 0 point. Each participant may get 12 points maximally and 0 point minimally.
  2. Attitudes (6 items, with 5 responses for each. Each response will earn 0-4 points respectively);
  3. Intentions (single item with 5 responses. Each response will earn 0-4 points respectively).

Higher scores indicate a better knowledge on informed choice of cataract surgery.
2 weeks post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decisional conflict
Time Frame: 2 weeks post intervention
Decisional conflict will be assessed using a 16-item Decisional Conflict Scale. Each item has 5 responses. Each response will earn 0-4 points respectively. Lower scores indicate a stronger ability to decide wheter or not receiving a cataract surgery.
2 weeks post intervention
Decisional confidence
Time Frame: 2 weeks post intervention
Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale. Each item has 5 responses. Each response will earn 0-4 points respectively. Higher scores indicate the paricipant is more confident about his/her decision.
2 weeks post intervention
Time perspective
Time Frame: 2 weeks post intervention
This will be assessed using a 4-item short form of the Consideration of Future Consequences Scale, with five response categories ranging from strongly agree (4 points) to strongly disagree (0 point). Higher scores indicate more consideration of future consequences by the participants.
2 weeks post intervention
Anticipated regret
Time Frame: 2 weeks post intervention
Two items from a validated scale will measure anticipated regret about having cataract surgery (action regret, 4 points) and about not having cataract (inaction regret, 0 point). Higher scores indicate higher probability of anticipated regret after the surgery.
2 weeks post intervention
Cataract worry
Time Frame: 2 weeks post intervention
A validated single item will measure participants' level of worry about progression of cataract, using four verbal response categories ranging from not worried at all to very worried. There are five response categories ranging from strongly agree (3 points) to strongly disagree (0 point). Higher scores indicate more worried about the disease status.
2 weeks post intervention
Cataract anxiety
Time Frame: 2 weeks post intervention
Anxiety will be measured with a six-item short form.A validated single item will measure participants' level of worry about progression of cataract, using four verbal response categories ranging from not worried at all to very worried. Each question has five response categories ranging from strongly agree (3 points) to strongly disagree (0 point). Higher scores indicate more anxious about the disease status.
2 weeks post intervention
Perceived importance of surgical benefit/harms
Time Frame: 2 weeks post intervention
Purpose-developed items will be used to ask participants about their personal perceptions of the importance of specific outcomes in their decision-making about cataract surgery. The questionare contains 2 items with 5 responses. Each response will earn 0-4 points respectively). Higher scores indicate a better knowledge on the understanding of importance of surgical benefit/harms.
2 weeks post intervention
Perceived importance of surgical benefit/harms
Time Frame: Time Frame: 2 weeks post intervention
Purpose-developed items will be used to ask participants about their personal perceptions of the importance of specific outcomes in their decision-making about cataract surgery. The questionnaire contains 2 items, each with 5 responses14. Each response will earn 0-4 points respectively). Higher scores indicate a better knowledge on the understanding of importance of surgical benefit/harms.
Time Frame: 2 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yingfeng Zheng, Zhognshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020KYPJ002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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