CataractNCT03216655
Individual vs Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
A study testing phone call and wechat group in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- phone call and wechat group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2017to 20 Aug 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- have other major life hit was diagnosed of anxiety and depression before
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Comparison of Individual and Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.
Read the detailed description
Congenital cataract (CC) is the leading cause of reversible blindness during childhood, which appears at birth or during the first decade of life. Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.
- Conditions
- Cataract
- Being tested
- phone call, wechat group
- Keywords
- congenital cataract, anxiety, guardian
- Medical subject headings
- Cataract, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone callOther
Investigators give a regular follow-up to participants: phone call monthly
wechat groupOther
Investigators give a regular follow-up to participants: wechat follow up. Investigators send useful information and answer their questions monthly.
| Study group | Role | What they receive |
|---|---|---|
| traditional group | Experimental | phone call Receives: Other: phone call |
| new device group | Experimental | wechat group Receives: Other: wechat group |
What is being measured
The primary outcome is the main question the study is designed to answer.
similar effect
the SAS and SDS level are same in two groups
Measured: baseline
efficient effect
the SAS and SDS level are higher in traditional group
Measured: baseline
invalid effect
the SAS and SDS level are lower in traditional group
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start11 Jul 2017
- Primary completion30 Dec 2017
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
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, M.D,Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216655
- Sponsor's protocol ID
- CCPMOH2017-China-1
- Status last verified
- Apr 2020
- First submitted
- 10 Jul 2017
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Individual and Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
- ClinicalTrials.gov ID
- NCT03216655
- Acronym / sponsor ID
- CCPMOH2017-China-1
- Conditions
- Cataract
- Keywords
- congenital cataract, anxiety, guardian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 13 Jul 2017 (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.
Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.
Detailed description
Congenital cataract (CC) is the leading cause of reversible blindness during childhood, which appears at birth or during the first decade of life. Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional group | Experimental | Other: phone callphone call |
| new device group | Experimental | Other: wechat groupwechat group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- have other major life hit was diagnosed of anxiety and depression before
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 |
|---|---|---|
| phone callInvestigators give a regular follow-up to participants: phone call monthly | Other | traditional group |
| wechat groupInvestigators give a regular follow-up to participants: wechat follow up. Investigators send useful information and answer their questions monthly. | Other | new device group |
Primary outcome
similar effect
Time frame: baseline
the SAS and SDS level are same in two groups
efficient effect
Time frame: baseline
the SAS and SDS level are higher in traditional group
invalid effect
Time frame: baseline
the SAS and SDS level are lower in traditional group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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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, M.D,Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phone call and wechat group in people with 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
similar effect (time frame: baseline). The study lists 3 primary outcomes in all. 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 14 Apr 2020.