- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216655
Individual vs Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
April 11, 2020 updated by: Haotian Lin, Sun Yat-sen University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
72
Phase
- 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
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Zhongshan 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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: the guardians of kids who had a surgery for congenital cataract recently
Exclusion Criteria:
have other major life hit was diagnosed of anxiety and depression before
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: traditional group
phone call
|
Investigators give a regular follow-up to participants: phone call monthly
|
Experimental: new device group
wechat group
|
Investigators give a regular follow-up to participants: wechat follow up.
Investigators send useful information and answer their questions monthly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
similar effect
Time Frame: baseline
|
the SAS and SDS level are same in two groups
|
baseline
|
efficient effect
Time Frame: baseline
|
the SAS and SDS level are higher in traditional group
|
baseline
|
invalid effect
Time Frame: baseline
|
the SAS and SDS level are lower in traditional group
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Haotian Lin, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
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)
July 11, 2017
Primary Completion (Actual)
December 30, 2017
Study Completion (Actual)
August 20, 2018
Study Registration Dates
First Submitted
July 10, 2017
First Submitted That Met QC Criteria
July 11, 2017
First Posted (Actual)
July 13, 2017
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 11, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCPMOH2017-China-1
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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