Effect of Mobile Communication on Childhood Cataract Follow-up Adherence

Cataract Clinical Trial

Official title:

Effect of a Mobile Phone Short Message Service (SMS) on Childhood Cataract Follow-up Adherence in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417819
• Other study ID #: CCPMOH2010-China1
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: August 27, 2011
• Start date: December 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• Mobile short message service
Mobile short message service reminder for appointments of parents of cataract children

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen U	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Padma TV. Developing solutions. Nature. 2010 Jul 15;466(7304):S16-7. doi: 10.1038/nature09242. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 24 weeks	No
Secondary	necessary management rates	Including:Surgery rates,laser treatment rates,replacement rates of glasses and incidence of secondary glaucoma	up to 24 weeks	No

External Links

•   Home of Cataract Children
•   Home page of ZHONGSHANG OPHTHALMIC CENTER