Clinical trial NCT03992807: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Age-related Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 773
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: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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: Perceived importance of surgical benefit/harms
timeFrame: 2 weeks post intervention
measure: Perceived personal chances of surgical benefit/harms
timeFrame: 2 weeks post intervention
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 and anxiety
timeFrame: 2 weeks post intervention
measure: Booklet utilization and acceptability
timeFrame: 2 weeks post intervention
measure: Undergoing cataract surgery
timeFrame: 1 year post intervention
measure: Decision regret
timeFrame: 1 year post intervention
measure: Visual functioning
timeFrame: Baseline, 1 year post intervention
measure: Fall questionnaire
timeFrame: 1 year post intervention
measure: Heath-related quality of life: Chinese version of the EQ-5D-5L telephone interview script
timeFrame: Baseline, 1 year post intervention
measure: Costs
timeFrame: Baseline, 1 year post intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
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.
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.
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.
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.