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Effect of Mobile Communication on Childhood Cataract Follow-up Adherence

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mobile short message service
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cataract

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • If the children were identified with congenital or development cataract before or after surgery, without other ocular abnormality
  • Parents were able to access a mobile phone on a near-daily basis and communicate via short message service (SMS).
  • Have signed a consent form
  • Can be followed

Exclusion Criteria:

  • Children not identified with congenital or development cataract
  • Parents without ownership of mobile phone
  • Have not signed consent form
  • Be not able to be followed

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen U

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SMS reminder

Arm Description

SMS reminders four days and one day before their appointments

Outcomes

Primary Outcome Measures

follow-up adherence
Follow-up adherence included the rates of attendance, non-attendance, and rates of several categories of attrition (withdrawal from the study, transfer to non-study clinics, and loss to follow-up without identifiable cause).

Secondary Outcome Measures

necessary management rates
Including:Surgery rates,laser treatment rates,replacement rates of glasses and incidence of secondary glaucoma

Full Information

First Posted
August 12, 2011
Last Updated
August 27, 2011
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China
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1. Study Identification

Unique Protocol Identification Number
NCT01417819
Brief Title
Effect of Mobile Communication on Childhood Cataract Follow-up Adherence
Official Title
Effect of a Mobile Phone Short Message Service (SMS) on Childhood Cataract Follow-up Adherence in China
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rigorous and regular follow-up is essential to successful management of childhood cataract, but it is often ignored by parents and especially difficult to be delivered in China, such an average-medical-resource-limited country. Health programmes that use mobile communication technologies are emerging with the aim of strengthening health systems. The investigators aimed to assess whether mobile phone short message service (SMS) for parents of cataract children involved in the Childhood Cataract Program of Ministry of Health of China (CCPMOH) improved follow-up adherence and detection rate of the timing of surgery, postoperative complications and necessary replacement of glasses.
Detailed Description
Congenital and developmental cataract is a priority of Vision 2020: the Right to Sight, the global initiative to reduce the world's burden of avoidable blindness, because it is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on early diagnosis and referral for surgery when indicated. Accurate optical rehabilitation and postoperative supervision are also essential. The timing of surgery of childhood cataract depends on the etiology and on the degree of visual interference. Severe bilateral cataracts with significant obstruction of the visual axis must be treated and surgery is recommended as soon as possible after discovery. Ideally cataracts should be removed before 3 months of age. In unilateral congenital cataract cases the prognosis for useful vision following surgery depends on prompt restoration of a clear visual axis, correction of aphakia, and aggressive treatment of amblyopia. In China, severe visual impairment is common in pediatric patients with cataract, and delayed presentation to hospital and late surgical treatment are found to be the major reasons. Therefore, in order to control childhood blindness and severe visual impairment in China, it is essential to ensure that pediatric patients with cataract could have good timing of surgery, postoperative rigorous supervision, accurate optical rehabilitation and aggressive treatment of amblyopia. The importance of follow-up has been widely accepted and applied for research by many clinical disciplines. It is no doubt that rigorous and regular follow-up is essential to successful management of childhood cataract, for the cataract degree and visual development are individually different and changing, and the long-term visual acuity might be influenced by many factors. In other word, individual strategy according to the results of follow-up is the best choice for management of childhood cataract. The key to make the most appropriate individual strategy for each cataract child is strict follow-up on the basis of good communication. However, communicating with children and their families is complex, routinely involves the physician-parent-child triad and other family members, and is influenced by the developmental and cognitive stage of the child, interaction dynamics within the family, and differing parent and child needs. In addition to communication difficulties, financial difficulty and transportation difficulties were also the common causes for pediatric patients' parents to refusal or abandonment of treatment plan in China. As a developing country, China's health-care level is currently unsatisfactory and the health-care reform still needs a long way to go. However, with the rapid economic development, Chinese cell phone users exceed 900 million people and this amount is to make China as a country with the largest number of mobile phone users in the world, mainly because of huge population and economic development, without factors related to healthcare. Actually, mobile phone communication has been suggested as a method to improve delivery of health services around the world, and most of the researches of health care via mobile phone are focused on HIV/AIDS, tuberculosis, and malaria. As an average-medical-resource-limited country but the largest mobile phone market, China should more use the potential of mobile technology in health systems compared to other countries. It is one of the goals of health-care reform that a wide range of medical services could be improved by providing patient-focused support and management through the health-care system. If mobile phone use does improve health outcomes in resource-limited settings, especially for chronic, congenital and developmental diseases needing good communication and collaboration, such as childhood cataract, this mobile health technology could thus be included in health-system strategies and help improve health development goals. In this trial, we aimed to assess whether mobile phone communication between pediatric ophthalmologists and parents of cataract children involved in the Childhood Cataract Program of Ministry of Health of China improved follow-up adherence and detection rate of the timing of surgery, postoperative complications and necessary replacement of glasses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS reminder
Arm Type
Other
Arm Description
SMS reminders four days and one day before their appointments
Intervention Type
Other
Intervention Name(s)
Mobile short message service
Other Intervention Name(s)
Fetion, China Mobile
Intervention Description
Mobile short message service reminder for appointments of parents of cataract children
Primary Outcome Measure Information:
Title
follow-up adherence
Description
Follow-up adherence included the rates of attendance, non-attendance, and rates of several categories of attrition (withdrawal from the study, transfer to non-study clinics, and loss to follow-up without identifiable cause).
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
necessary management rates
Description
Including:Surgery rates,laser treatment rates,replacement rates of glasses and incidence of secondary glaucoma
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: If the children were identified with congenital or development cataract before or after surgery, without other ocular abnormality Parents were able to access a mobile phone on a near-daily basis and communicate via short message service (SMS). Have signed a consent form Can be followed Exclusion Criteria: Children not identified with congenital or development cataract Parents without ownership of mobile phone Have not signed consent form Be not able to be followed
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
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D., Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Weirong Cheng, M.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen U
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20709402
Citation
You C, Wu X, Zhang Y, Dai Y, Huang Y, Xie L. Visual impairment and delay in presentation for surgery in chinese pediatric patients with cataract. Ophthalmology. 2011 Jan;118(1):17-23. doi: 10.1016/j.ophtha.2010.04.014. Epub 2010 Aug 14.
Results Reference
background
PubMed Identifier
17003414
Citation
Chak M, Wade A, Rahi JS; British Congenital Cataract Interest Group. Long-term visual acuity and its predictors after surgery for congenital cataract: findings of the British congenital cataract study. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4262-9. doi: 10.1167/iovs.05-1160.
Results Reference
background
PubMed Identifier
18777421
Citation
Rider EA, Volkan K, Hafler JP. Pediatric residents' perceptions of communication competencies: Implications for teaching. Med Teach. 2008;30(7):e208-17. doi: 10.1080/01421590802208842.
Results Reference
background
PubMed Identifier
20631698
Citation
Padma TV. Developing solutions. Nature. 2010 Jul 15;466(7304):S16-7. doi: 10.1038/nature09242. No abstract available.
Results Reference
background
PubMed Identifier
19382860
Citation
Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.
Results Reference
background
PubMed Identifier
19135907
Citation
Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040.
Results Reference
background
PubMed Identifier
21071074
Citation
Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.
Results Reference
background
PubMed Identifier
22921386
Citation
Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.
Results Reference
derived
Links:
URL
http://www.gzzoc.com/
Description
Home page of ZHONGSHANG OPHTHALMIC CENTER
URL
http://www.cnccclub.com/
Description
Home of Cataract Children

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Effect of Mobile Communication on Childhood Cataract Follow-up Adherence

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