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Age-related CataractNCT03992807

A Decision Aid for Patients With Age-related Cataract

A study testing A patient decision aid and A usual education booklet in people with Age-related Cataract, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Age-related Cataract
What is being tested?
A patient decision aid and A usual education booklet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
773 participants
Where
1 siteChina
Study dates
1 Jul 2019to 12 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhognshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

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

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

Read the 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.

Being tested
A patient decision aid, A usual education booklet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A patient decision aidOther

    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 bookletOther

    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.

Study groups in NCT03992807
Study groupRoleWhat they receive
A patient decision aidExperimentalA 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.
Receives: Other: A patient decision aid
A usual education bookletActive comparatorA traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.
Receives: Other: A usual education booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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")

    Measured: 2 weeks post intervention

Secondary outcomes (14)

  1. 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.

    Measured: 2 weeks post intervention

  2. 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.

    Measured: 2 weeks post intervention

  3. Decisional conflict

    Decisional conflict will be assessed using a 16-item Decisional Conflict Scale.

    Measured: 2 weeks post intervention

  4. Decisional confidence

    Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.

    Measured: 2 weeks post intervention

  5. 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.

    Measured: 2 weeks post intervention

  6. 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).

    Measured: 2 weeks post intervention

  7. 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.

    Measured: 2 weeks post intervention

  8. 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.

    Measured: 2 weeks post intervention

  9. Undergoing cataract surgery

    Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.

    Measured: 1 year post intervention

  10. Decision regret

    The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.

    Measured: 1 year post intervention

  11. Visual functioning

    This will be assessed using the Catquest 9SF questionnaire.

    Measured: Baseline, 1 year post intervention

  12. 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?"

    Measured: 1 year post intervention

  13. 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.

    Measured: Baseline, 1 year post intervention

  14. Costs

    This will be assessed using the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) questionnaire.

    Measured: Baseline, 1 year post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2019
  2. Study start1 Jul 2019
  3. Primary completion12 Nov 2019
  4. Study completion12 Nov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
773 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03992807
Sponsor's protocol ID
2019KYPJ090
Status last verified
Mar 2020
First submitted
11 Jun 2019
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29032195

  • 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.

    PubMed 26036605

  • 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.

    PubMed 10209437

  • 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.

    PubMed 32430445

Questions about this trial

What is this clinical trial studying?

A study testing A patient decision aid and A usual education booklet in people with Age-related Cataract, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 2 weeks post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03992807, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020; AzTrials last refreshed its copy on 3 Nov 2026.

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