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Completed

NCT Number: NCT04262596

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

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.

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Key information

Conditions

Age-related Cataract

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Interactive Consulting System

Other

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.

A traditional patient decision aid brochure

Other

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.

Primary outcomes

  1. 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:

    • 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.
    • Attitudes (6 items, with 5 responses for each. Each response will earn 0-4 points respectively);
    • 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2020
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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