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AzTrials

CataractNCT01417819

Effect of Mobile Communication on Childhood Cataract Follow-up Adherence

A study testing Mobile short message service in people with Cataract, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Cataract
What is being tested?
Mobile short message service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
1 siteChina
Study dates
Dec 2010to Aug 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Zhongshan Ophthalmic Center, Sun Yat-sen U

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Cataract
Being tested
Mobile short message service
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile short message serviceOther

    Also called Fetion, China Mobile

    Mobile short message service reminder for appointments of parents of cataract children

Study groups in NCT01417819
Study groupRoleWhat they receive
SMS reminderOtherSMS reminders four days and one day before their appointments
Receives: Other: Mobile short message service

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: up to 24 weeks

Secondary outcomes (1)
  1. necessary management rates

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

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01417819
Sponsor's protocol ID
CCPMOH2010-China1
Status last verified
Aug 2011
First submitted
12 Aug 2011
Last updated
30 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20709402
  • 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.

    PubMed 17003414
  • 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.

    PubMed 18777421
  • Padma TV. Developing solutions. Nature. 2010 Jul 15;466(7304):S16-7. doi: 10.1038/nature09242. No abstract available.

    PubMed 20631698
  • 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.

    PubMed 19382860
  • 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.

    PubMed 19135907
  • 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.

    PubMed 21071074
  • 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.

    PubMed 22921386

Questions about this trial

What is this clinical trial studying?

A study testing Mobile short message service in people with Cataract, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

follow-up adherence (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01417819, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.

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