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Age-related CataractNCT04262596

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

A study testing Interactive Consulting System and A traditional patient decision aid brochure in people with Age-related Cataract, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Age-related Cataract
What is being tested?
Interactive Consulting System and A traditional patient decision aid brochure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
492 participants
Where
1 siteChina
Study dates
1 May 2023to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhognshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

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.

Read the 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.

Being tested
Interactive Consulting System, A traditional patient decision aid brochure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive Consulting SystemOther

    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 brochureOther

    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.

Study groups in NCT04262596
Study groupRoleWhat they receive
Interactive Consulting SystemExperimentalThe 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.
Receives: Other: Interactive Consulting System
Traditional decision aid brochureActive comparatorA 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.
Receives: Other: A traditional patient decision aid brochure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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.

    Measured: 2 weeks post intervention

Secondary outcomes (8)

  1. Decisional conflict

    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.

    Measured: 2 weeks post intervention

  2. Decisional confidence

    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.

    Measured: 2 weeks post intervention

  3. Time perspective

    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.

    Measured: 2 weeks post intervention

  4. Anticipated regret

    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.

    Measured: 2 weeks post intervention

  5. Cataract worry

    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.

    Measured: 2 weeks post intervention

  6. Cataract anxiety

    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.

    Measured: 2 weeks post intervention

  7. Perceived importance of surgical benefit/harms

    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.

    Measured: 2 weeks post intervention

  8. Perceived importance of surgical benefit/harms

    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.

    Measured: Time Frame: 2 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start1 May 2023
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
492 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262596
Sponsor's protocol ID
2020KYPJ002
Status last verified
Dec 2023
First submitted
23 Jan 2020
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Interactive Consulting System and A traditional patient decision aid brochure in people with Age-related Cataract, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04262596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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