A Decision Aid for Patients With Age-related Cataract

March 1, 2020 updated by: Yingfeng Zheng, Sun Yat-sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
773

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhognshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: A patient decision aid
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
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.
ACTIVE_COMPARATOR: A usual education booklet
A traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived importance of surgical benefit/harms
Time Frame: 2 weeks post intervention
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
Perceived personal chances of surgical benefit/harms
Time Frame: 2 weeks post intervention
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
Decisional conflict
Time Frame: 2 weeks post intervention
Decisional conflict will be assessed using a 16-item Decisional Conflict Scale.
2 weeks post intervention
Decisional confidence
Time Frame: 2 weeks post intervention
Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.
2 weeks post intervention
Time perspective
Time Frame: 2 weeks post intervention
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
Anticipated regret
Time Frame: 2 weeks post intervention
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
Cataract worry and anxiety
Time Frame: 2 weeks post intervention
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
Booklet utilization and acceptability
Time Frame: 2 weeks post intervention

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.
2 weeks post intervention
Undergoing cataract surgery
Time Frame: 1 year post intervention
Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.
1 year post intervention
Decision regret
Time Frame: 1 year post intervention
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
Visual functioning
Time Frame: Baseline, 1 year post intervention
This will be assessed using the Catquest 9SF questionnaire.
Baseline, 1 year post intervention
Fall questionnaire
Time Frame: 1 year post intervention
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
Heath-related quality of life: Chinese version of the EQ-5D-5L telephone interview script
Time Frame: Baseline, 1 year post intervention
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
Costs
Time Frame: Baseline, 1 year post intervention
This will be assessed using the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) questionnaire.
Baseline, 1 year post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019KYPJ090

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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