Back to resultsA Decision Aid for Patients With Age-related Cataract
Primary Purpose
Age-related Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A patient decision aid
A usual education booklet
Sponsored by
About this trial
This is an interventional health services research trial for Age-related Cataract
Eligibility Criteria
Inclusion Criteria:
- Individuals aged 50-80 years who have been resident in the selected study district for more than six months;
- A definite diagnosis of age-related cataract;
- Having not received cataract surgery;
- Willing to participate in the study and provide informed content.
Exclusion criteria
- Bilateral blindness (presenting distance visual acuity worse than 3/60);
- Having ocular, hearing or mental disorder precluding reading or telephone interview;
- Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
- Having cataract surgery contraindication.
Sites / Locations
- Zhognshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A patient decision aid
A usual education booklet
Arm Description
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.
A traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.
Outcomes
Primary Outcome Measures
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")
Secondary Outcome Measures
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.
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.
Decisional conflict
Decisional conflict will be assessed using a 16-item Decisional Conflict Scale.
Decisional confidence
Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.
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.
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).
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.
Booklet utilization and acceptability
Acceptability and utilization of materials will be assessed based on the following items:
the proportion of participants who could read the booklet all the way through;
the proportion of participants who agree that the information is new;
the proportion of participants who agree that the length is just about right;
the proportion of participants who think the information is balanced;
the proportion of participants who agree that the booklet is clear and easy to understand;
the proportion of participants who find the materials helpful;
the proportion of participants who feel it worth recommending to others.
Undergoing cataract surgery
Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.
Decision regret
The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.
Visual functioning
This will be assessed using the Catquest 9SF questionnaire.
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?"
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.
Costs
This will be assessed using the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03992807
Brief Title
A Decision Aid for Patients With Age-related Cataract
Official Title
Patient-centered and Economic Effectiveness of a Decision Aid for Patients With Age-related Cataract: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 12, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cataract
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
773 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A patient decision aid
Arm Type
Experimental
Arm Description
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.
Arm Title
A usual education booklet
Arm Type
Active Comparator
Arm Description
A traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.
Intervention Type
Other
Intervention Name(s)
A patient decision aid
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
A usual education booklet
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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
Secondary Outcome Measure Information:
Title
Perceived importance of surgical benefit/harms
Description
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
Title
Perceived personal chances of surgical benefit/harms
Description
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
Title
Decisional conflict
Description
Decisional conflict will be assessed using a 16-item Decisional Conflict Scale.
Time Frame
2 weeks post intervention
Title
Decisional confidence
Description
Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.
Time Frame
2 weeks post intervention
Title
Time perspective
Description
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
Title
Anticipated regret
Description
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
Title
Cataract worry and anxiety
Description
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
Title
Booklet utilization and acceptability
Description
Acceptability and utilization of materials will be assessed based on the following items:
the proportion of participants who could read the booklet all the way through;
the proportion of participants who agree that the information is new;
the proportion of participants who agree that the length is just about right;
the proportion of participants who think the information is balanced;
the proportion of participants who agree that the booklet is clear and easy to understand;
the proportion of participants who find the materials helpful;
the proportion of participants who feel it worth recommending to others.
Time Frame
2 weeks post intervention
Title
Undergoing cataract surgery
Description
Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.
Time Frame
1 year post intervention
Title
Decision regret
Description
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
Title
Visual functioning
Description
This will be assessed using the Catquest 9SF questionnaire.
Time Frame
Baseline, 1 year post intervention
Title
Fall questionnaire
Description
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
Title
Heath-related quality of life: Chinese version of the EQ-5D-5L telephone interview script
Description
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
Title
Costs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals aged 50-80 years who have been resident in the selected study district for more than six months;
A definite diagnosis of age-related cataract;
Having not received cataract surgery;
Willing to participate in the study and provide informed content.
Exclusion criteria
Bilateral blindness (presenting distance visual acuity worse than 3/60);
Having ocular, hearing or mental disorder precluding reading or telephone interview;
Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
Having cataract surgery contraindication.
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29032195
Citation
Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, Das A, Jonas JB, Keeffe J, Kempen JH, Leasher J, Limburg H, Naidoo K, Pesudovs K, Silvester A, Stevens GA, Tahhan N, Wong TY, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017 Dec;5(12):e1221-e1234. doi: 10.1016/S2214-109X(17)30393-5. Epub 2017 Oct 11.
Results Reference
background
PubMed Identifier
26036605
Citation
Kessel L, Andresen J, Erngaard D, Flesner P, Tendal B, Hjortdal J. Indication for cataract surgery. Do we have evidence of who will benefit from surgery? A systematic review and meta-analysis. Acta Ophthalmol. 2016 Feb;94(1):10-20. doi: 10.1111/aos.12758. Epub 2015 Jun 3.
Results Reference
background
PubMed Identifier
10209437
Citation
McCarty CA, Keeffe JE, Taylor HR. The need for cataract surgery: projections based on lens opacity, visual acuity, and personal concern. Br J Ophthalmol. 1999 Jan;83(1):62-5. doi: 10.1136/bjo.83.1.62.
Results Reference
background
PubMed Identifier
32430445
Citation
Zheng Y, Qu B, Jin L, Wang C, Zhong Y, He M, Liu Y. Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial. BMJ Open. 2020 May 18;10(5):e032242. doi: 10.1136/bmjopen-2019-032242.
Results Reference
derived
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A Decision Aid for Patients With Age-related Cataract
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