An interventional study of A patient decision aid and A usual education booklet in Age-related Cataract, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Health services research
To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.
The need for cataract surgery is on the rise globally due to the aging population and high demands for greater visual functioning. Patients with age-related cataract face their initial decision about when to undergo cataract surgery. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The purpose of this study is to determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 773 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion criteria
A patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise.
Other: A patient decision aid
A traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.
Other: A usual education booklet
Potential participants receive a printed decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
Potential participants receive a usual booklet about cataract and cataract surgery, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
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 (items 1-10) and numerical (items 11-12) knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses) Analysis: Informed Choice= Good Knowledge (score ≥50% in basic knowledge, ≥40% in knowledge associated with each treatment option, and at least 1 point in each numerical knowledge question) AND Positive Attitude (score ≥24) AND Positive Intention ("definitely will" or "likely to"), OR Good Knowledge AND Negative Attitude (score \<23) AND Negative Intention ("unsure", "not likely to", or "definitely will not")
Time frame: 2 weeks post intervention
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.
Time frame: 2 weeks post intervention
Perceived personal chances of surgical benefit/harms
Participants will be asked about their perceived personal likelihood of experiencing specific outcomes if they have cataract surgeries, compared with an average patient who had undergone cataract surgery.
Time frame: 2 weeks post intervention
Decisional conflict
Decisional conflict will be assessed using a 16-item Decisional Conflict Scale.
Time frame: 2 weeks post intervention
Decisional confidence
Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.
Time frame: 2 weeks post intervention
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 to strongly disagree.
Time frame: 2 weeks post intervention
Anticipated regret
Two items from a validated scale will measure anticipated regret about having cataract surgery (action regret) and about not having cataract (inaction regret).
Time frame: 2 weeks post intervention
Cataract worry and anxiety
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. Anxiety will be measured with a six-item short form.
Time frame: 2 weeks post intervention
Booklet utilization and acceptability
Acceptability and utilization of materials will be assessed based on the following items: 1. the proportion of participants who could read the booklet all the way through; 2. the proportion of participants who agree that the information is new; 3. the proportion of participants who agree that the length is just about right; 4. the proportion of participants who think the information is balanced; 5. the proportion of participants who agree that the booklet is clear and easy to understand; 6. the proportion of participants who find the materials helpful; 7. the proportion of participants who feel it worth recommending to others.
Time frame: 2 weeks post intervention
Undergoing cataract surgery
Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.
Time frame: 1 year post intervention
Decision regret
The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.
Time frame: 1 year post intervention
Visual functioning
This will be assessed using the Catquest 9SF questionnaire.
Time frame: Baseline, 1 year post intervention
Fall questionnaire
This will be assessed using a single item question "Did you have any fall in the past 12 months whereby you landed on the ground or floor?"
Time frame: 1 year post intervention
Heath-related quality of life: Chinese version of the EQ-5D-5L telephone interview script
This will be assessed using the simplified Chinese version of the EQ-5D-5L telephone interview script from the EuroQol research foundation.
Time frame: Baseline, 1 year post intervention
Costs
This will be assessed using the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) questionnaire.
Time frame: Baseline, 1 year post intervention
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University