Clinical trial NCT04262596: Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial
Official title: Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 492
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: 2 weeks post intervention
Secondary outcomes:
measure: Decisional conflict
timeFrame: 2 weeks post intervention
measure: Decisional confidence
timeFrame: 2 weeks post intervention
measure: Time perspective
timeFrame: 2 weeks post intervention
measure: Anticipated regret
timeFrame: 2 weeks post intervention
measure: Cataract worry
timeFrame: 2 weeks post intervention
measure: Cataract anxiety
timeFrame: 2 weeks post intervention
measure: Perceived importance of surgical benefit/harms
timeFrame: 2 weeks post intervention
measure: Perceived importance of surgical benefit/harms
timeFrame: Time Frame: 2 weeks post intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhognshan Ophthalmic Center, Sun Yat-sen University
name: Yingfeng Zheng
role: PRINCIPAL_INVESTIGATOR
References: