Age-related Cataract Clinical Trial
Official title:
Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial
NCT number | NCT04262596 |
Other study ID # | 2020KYPJ002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | August 31, 2023 |
Verified date | December 2023 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 492 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Zhognshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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:
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. |
2 weeks post intervention | |
Secondary | 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. | 2 weeks post intervention | |
Secondary | 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. | 2 weeks post intervention | |
Secondary | 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. | 2 weeks post intervention | |
Secondary | 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. | 2 weeks post intervention | |
Secondary | 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. | 2 weeks post intervention | |
Secondary | 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. | 2 weeks post intervention | |
Secondary | 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. | 2 weeks post intervention | |
Secondary | 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. | Time Frame: 2 weeks post intervention |
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