A Decision Aid for Patients With Age-related Cataract

Age-related Cataract Clinical Trial

Official title:

Patient-centered and Economic Effectiveness of a Decision Aid for Patients With Age-related Cataract: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992807
• Other study ID #: 2019KYPJ090
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: November 12, 2020

Study information

• Verified date: March 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 773
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Individuals aged 50-80 years who have been resident in the selected study district for more than six months;

2. A definite diagnosis of age-related cataract;

3. Having not received cataract surgery;

4. Willing to participate in the study and provide informed content.

Exclusion criteria

1. Bilateral blindness (presenting distance visual acuity worse than 3/60);

2. Having ocular, hearing or mental disorder precluding reading or telephone interview;

3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;

4. Having cataract surgery contraindication.

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

Intervention

Other:
• A patient decision aid
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.
• A usual education booklet
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.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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")	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.	2 weeks post intervention
Secondary	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.	2 weeks post intervention
Secondary	Decisional conflict	Decisional conflict will be assessed using a 16-item Decisional Conflict Scale.	2 weeks post intervention
Secondary	Decisional confidence	Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.	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 to strongly disagree.	2 weeks post intervention
Secondary	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).	2 weeks post intervention
Secondary	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.	2 weeks post intervention
Secondary	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.	2 weeks post intervention
Secondary	Undergoing cataract surgery	Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.	1 year post intervention
Secondary	Decision regret	The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.	1 year post intervention
Secondary	Visual functioning	This will be assessed using the Catquest 9SF questionnaire.	Baseline, 1 year post intervention
Secondary	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?"	1 year post intervention
Secondary	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.	Baseline, 1 year post intervention
Secondary	Costs	This will be assessed using the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) questionnaire.	Baseline, 1 year post intervention