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Age Related CataractsNCT03525015

Impact of a Printed Decision Aid on Cataract Surgery Choice

A study testing A decision aid booklet about cataract surgery choice and An usual booklet about cataract and cataract surgery in people with Age Related Cataracts, run by Sun Yat-sen University at 11 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Age Related Cataracts
What is being tested?
A decision aid booklet about cataract surgery choice and An usual booklet about cataract and cataract surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
696 participants
Where
11 sitesChina
Study dates
16 May 2018to 30 Oct 2019
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

  • Definite diagnosis of age-related cataract;
  • The best corrected visual acuity (BCVA) is above 20/60;
  • Cataract opacity meets any of the following criterion based on lens opacity classification system (LOCS) III: nuclear color and nuclear opalescence is greater than or equal to grade 2 (NO2/NC2); cortical opacity is greater than or equal to grade 2 (C2); posterior subcapsular opacity is greater than or equal to grade 2 (P2);
  • Willing to know about cataract and cataract surgery;
  • Being able to afford cataract surgery;
  • Willing to participate in the study and provide the informed content.

Who cannot join

  • Having received cataract surgery;
  • Having hearing disorders;
  • Having mental disorders;
  • Having ocular disorders other than cataract;
  • Having surgery contraindication;
  • Unwilling to participate in this study.

Trial locations and contacts

11 sites in 1 country.

Yingfeng Zheng, M.D. Ph.D. contact

+8613922286455

zhyfeng@mail.sysu.edu.cn

11 sites in 1 country

China11 sites, 11 recruiting

  • Dashi Community Health Center

    Guangzhou

    Yurong Hu

    Recruiting

  • Donghuan Community Health Center

    Guangzhou

    Qiuling Xia

    Recruiting

  • Huangcun Community Health Center

    Guangzhou

    Shaochun Wang

    Recruiting

  • Huaying Community Health Center

    Guangzhou

    Haifeng Wang

    Recruiting

  • Qiaonan Community Health Center

    Guangzhou

    Weijian Chen

    Recruiting

  • Shawan Community Health Center

    Guangzhou

    Yu Wong

    Recruiting

  • Shibi Community Health Center

    Guangzhou

    Feiming Fan

    Recruiting

  • Shiqiao Community Health Center

    Guangzhou

    Zhenhong Chen

    Recruiting

  • Xiayuan Community Health Center

    Guangzhou

    Jiang Tan

    Recruiting

  • Yuancun Community Health Center

    Guangzhou

    Baoli Liu

    Recruiting

  • Zhognshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou

    Yizhi Liu

    Recruiting

Other trials in China

About this study

Official title: Impact of a Printed Decision Aid on Cataract Surgery Choice: A Multi-center Randomized Controlled Trial

The purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery.

Read the detailed description

Shared decision making is increasingly recommended to facilitate quality care, but there is a lack of cataract surgery decision aid in clinical practice. The aim of this study is to evaluate the effectiveness of a cataract surgery decision aid for cataract patients with different levels of health literacy.

We will conduct a randomized controlled trial for cataract patients aged 50-80 years. We will randomly assign participants to either the intervention using a decision aid booklet or the one using a usual cataract booklet. The primary outcome is informed choice (defined as adequate knowledge and consistency between attitudes and intentions) 2 weeks after intervention.

Being tested
A decision aid booklet about cataract surgery choice, An usual booklet about cataract and cataract surgery

What participants receive

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

  • A decision aid booklet about cataract surgery choiceOther

    Potential participants receive a 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.

  • An usual booklet about cataract and cataract surgeryOther

    Potential participants receive an usual booklet with information 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 NCT03525015
Study groupRoleWhat they receive
A decision aid bookletExperimentalA decision aid booklet about cataract surgery choice
Receives: Other: A decision aid booklet about cataract surgery choice
An usual bookletActive comparatorAn usual booklet about cataract and cataract surgery
Receives: Other: An usual booklet about cataract and cataract surgery

What is being measured

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

  1. Informed choice about cataract surgery

    Informed choice is measured as the proportion of participants who make an informed choice about whether to receive cataract surgery as soon as possible or not. For the individual, making an informed choice is defined as (i) having adequate knowledge and (ii) expressing intentions that are consistent with （iii）one's attitudes. Knowledge will be measured by assessing participants' understanding of the numerical and conceptual information in the booklets, using items modified from previous screening decision aid trials (Hersch 2015). Attitudes towards cataract surgery will be assessed using a theory-based generic screening attitudes scale (Dormandy 2006). A single item will measure intentions about having cataract surgery as soon as possible (or not), using a set of 5 response options (Gwyn 2003; Watson 2006).

    Measured: 2 weeks

Secondary outcomes (10)

  1. Perceived importance of cataract surgery 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. Participants will be asked how important it is to (i) have significant increase in vision-related quality of life, and (ii) have no significant increase in vision-related quality of life after receiving cataract surgery as soon as possible. The four response options range from very important to not at all important (Hersch 2014).

    Measured: 2 weeks

  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 surgery as soon as possible, compared with an average patient who had undergone cataract surgery, using five response categories ranging from much lower to much higher (Longman 2012).

    Measured: 2 weeks

  3. Decisional conflict

    Decisional conflict will be measured using a scale named Decisional Conflict Scale. The scale is made of 16 items, using five response scores ranging from 0 to 4. The lower values represent a better outcome.

    Measured: 2 weeks

  4. Decisional confidence

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

    Measured: 2 weeks

  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

  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

  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

  8. Booklet utilization and acceptability

    We examined the utilization and acceptability of the decision aid using closed and open ended questions. Perceptions of the decision aid, in terms of its length, clarity, balance and usefulness in decision making were elicited using a modified scale (Mathieu 2010) (Smith 2009). We also asked participants to comment on their design preferences towards the booklets.

    Measured: 2 weeks

  9. Undergoing cataract surgery

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

    Measured: 1 year

  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

Timeline

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

  1. First posted15 May 2018
  2. Study start16 May 2018
  3. Primary completion30 Oct 2018
  4. Study completion30 Oct 2019 (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
696 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525015
Sponsor's protocol ID
2017KYPJ066
Status last verified
Dec 2018
First submitted
12 Apr 2018
Last updated
26 Dec 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing A decision aid booklet about cataract surgery choice and An usual booklet about cataract and cataract surgery in people with Age Related Cataracts, run by Sun Yat-sen University at 11 sites 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 6 inclusion and 6 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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?

Contact Yingfeng Zheng, M.D. Ph.D. (+8613922286455, zhyfeng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Informed choice about cataract surgery (time frame: 2 weeks). 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 NCT03525015.

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 26 Dec 2018.

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