A Decision Aid for Patients With Age-related Cataract

NCT03992807 | Unknown DMC

• 1 other identifier: 2019KYPJ090
• Study Type: interventional
• Target: 773
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Age-related Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Perceived importance of surgical benefit/harms

  2 weeks post intervention

• Perceived personal chances of surgical benefit/harms

  2 weeks post intervention

• Decisional conflict

  2 weeks post intervention

• Decisional confidence

  2 weeks post intervention

• Time perspective

  2 weeks post intervention

Study Arms (2)

A patient decision aid

EXPERIMENTAL

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 usual education booklet

ACTIVE COMPARATOR

A traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.

Other: A usual education booklet

Interventions

A patient decision aid OTHER

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 patient decision aid

A usual education booklet OTHER

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.

A usual education booklet

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (4)

• 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.

  PMID: 29032195 BACKGROUND

• 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.

  PMID: 26036605 BACKGROUND

• 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.

  PMID: 10209437 BACKGROUND

• 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.

  PMID: 32430445 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 20, 2019
• Study Start: July 1, 2019
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

CN (1)