Effect of Mobile Communication on Childhood Cataract Follow-up Adherence

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01417819
First received: August 12, 2011
Last updated: August 27, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Cataract
Other: Mobile short message service

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of a Mobile Phone Short Message Service (SMS) on Childhood Cataract Follow-up Adherence in China

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • follow-up adherence [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Including:Surgery rates,laser treatment rates,replacement rates of glasses and incidence of secondary glaucoma


Enrollment: 258
Study Start Date: December 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SMS reminder
SMS reminders four days and one day before their appointments
Other: Mobile short message service
Mobile short message service reminder for appointments of parents of cataract children
Other Name: Fetion, China Mobile

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01417819

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen U
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Health, China
Investigators
Principal Investigator: Haotian Lin, M.D., Ph.D. Zhongshan Ophthalmic Center
Study Chair: Yizhi Liu, M.D., Ph.D. Zhongshan Ophthalmic Center
Study Director: Weirong Cheng, M.D. Zhongshan Ophthalmic Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haotian Lin, Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01417819     History of Changes
Other Study ID Numbers: CCPMOH2010-China1
Study First Received: August 12, 2011
Last Updated: August 27, 2011
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014