Congenital CataractNCT03564990
The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract
A study testing interactive, multifaceted approach and conventional approach in people with Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- interactive, multifaceted approach and conventional approach
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2018to 30 Jun 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with regulated cataract surgery
Who cannot join
- difficulty in understanding the language
- uncompleted questionnaires or badly filled in by two different people
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D., 8613802793086, haot.lin@hotmail.com
Jing Li, M.D., +86-20-87330341, Reviewborad_SYsU@163.com
About this study
Official title: The Impact of Interactive, Multifaceted Approach Education on Parental Anxiety, Knowledge and Satisfaction for Congenital Cataract: A Randomized, Controlled Trial
To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.
Read the detailed description
Prospective study including parents of congenital cataract, randomized in two groups: health education program with an interactive, multifaceted approach versus conventional follow-up. A health education module consisting of a lecture and workshop was incorporated into a health-care course. A non-validated survey assessed knowledge. Parental stress was assessed using self-questionnaires before and after training .At each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data.
- Conditions
- Congenital Cataract
- Being tested
- interactive, multifaceted approach, conventional approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive, multifaceted approachOther
A health education module consisting of a lecture and workshop was incorporated into a health-care course.
conventional approachOther
conventional follow-up
| Study group | Role | What they receive |
|---|---|---|
| interactive, multifaceted approach | Experimental | A health education module consisting of a lecture and workshop was incorporated into a health-care course. Receives: Other: interactive, multifaceted approach |
| conventional approach | Sham comparator | conventional follow-up with oral healthy education Receives: Other: conventional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting stress
Parenting stress was assessed using the Parenting Stress Index (PSI)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start30 Jun 2018 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, Ph.D, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564990
- Sponsor's protocol ID
- CCPMOH2018-China-3
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Interactive, Multifaceted Approach Education on Parental Anxiety, Knowledge and Satisfaction for Congenital Cataract: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03564990
- Acronym / sponsor ID
- CCPMOH2018-China-3
- Conditions
- Congenital Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.
Detailed description
Prospective study including parents of congenital cataract, randomized in two groups: health education program with an interactive, multifaceted approach versus conventional follow-up. A health education module consisting of a lecture and workshop was incorporated into a health-care course. A non-validated survey assessed knowledge. Parental stress was assessed using self-questionnaires before and after training .At each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interactive, multifaceted approach | Experimental | Other: interactive, multifaceted approachA health education module consisting of a lecture and workshop was incorporated into a health-care course. |
| conventional approach | Sham comparator | Other: conventional approachconventional follow-up with oral healthy education |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with regulated cataract surgery
Key exclusion criteria (2 listed)
- difficulty in understanding the language
- uncompleted questionnaires or badly filled in by two different people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interactive, multifaceted approachA health education module consisting of a lecture and workshop was incorporated into a health-care course. | Other | interactive, multifaceted approach |
| conventional approachconventional follow-up | Other | conventional approach |
Primary outcome
Parenting stress
Time frame: 12 months
Parenting stress was assessed using the Parenting Stress Index (PSI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haotian Lin, Ph.D principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive, multifaceted approach and conventional approach in people with Congenital 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 1 inclusion and 2 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 21 Jun 2018. 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. Some participants in this study may receive a placebo. 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 Haotian Lin, Ph.D (+86-20-87330341, mailto:haot.lin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting stress (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2018.