Back to resultsIndividual vs Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
phone call
wechat group
Sponsored by
About this trial
This is an interventional health services research trial for Cataract focused on measuring congenital cataract, anxiety, guardian
Eligibility Criteria
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
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
traditional group
new device group
Arm Description
phone call
wechat group
Outcomes
Primary Outcome Measures
similar effect
the SAS and SDS level are same in two groups
efficient effect
the SAS and SDS level are higher in traditional group
invalid effect
the SAS and SDS level are lower in traditional group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03216655
Brief Title
Individual vs Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
Official Title
Comparison of Individual and Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
August 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
congenital cataract, anxiety, guardian
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional group
Arm Type
Experimental
Arm Description
phone call
Arm Title
new device group
Arm Type
Experimental
Arm Description
wechat group
Intervention Type
Other
Intervention Name(s)
phone call
Intervention Description
Investigators give a regular follow-up to participants: phone call monthly
Intervention Type
Other
Intervention Name(s)
wechat group
Intervention Description
Investigators give a regular follow-up to participants: wechat follow up. Investigators send useful information and answer their questions monthly.
Primary Outcome Measure Information:
Title
similar effect
Description
the SAS and SDS level are same in two groups
Time Frame
baseline
Title
efficient effect
Description
the SAS and SDS level are higher in traditional group
Time Frame
baseline
Title
invalid effect
Description
the SAS and SDS level are lower in traditional group
Time Frame
baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D,Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Individual vs Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
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