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.
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
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 group | Role | What they receive |
|---|---|---|
| SMS reminder | Other | SMS 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.
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)
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.
- First posted16 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D., Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D., Ph.D., Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityWeirong Cheng, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
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 20709402Chak 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 17003414Rider 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 18777421Padma TV. Developing solutions. Nature. 2010 Jul 15;466(7304):S16-7. doi: 10.1038/nature09242. No abstract available.
PubMed 20631698Krishna 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 19382860Fjeldsoe 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 19135907Lester 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 21071074Lin 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mobile Phone Short Message Service (SMS) on Childhood Cataract Follow-up Adherence in China
- ClinicalTrials.gov ID
- NCT01417819
- Acronym / sponsor ID
- CCPMOH2010-China1
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMS reminder | Other | Other: Mobile short message serviceSMS reminders four days and one day before their appointments |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile short message serviceAlso: Fetion, China MobileMobile short message service reminder for appointments of parents of cataract children | Other | SMS reminder |
Primary outcome
follow-up adherence
Time frame: up to 24 weeks
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).
1 secondary outcome
necessary management rates
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
- Background: PubMed 20709402You 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.
- Background: PubMed 17003414Chak 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.
- Background: PubMed 18777421Rider 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.
- Background: PubMed 20631698Padma TV. Developing solutions. Nature. 2010 Jul 15;466(7304):S16-7. doi: 10.1038/nature09242. No abstract available.
- Background: PubMed 19382860Krishna 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.
- Background: PubMed 19135907Fjeldsoe 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.
- Background: PubMed 21071074Lester 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.
- Derived from this study: PubMed 22921386Lin 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.
- Home page of ZHONGSHANG OPHTHALMIC CENTERLink provided by the sponsor.
- Home of Cataract ChildrenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haotian Lin, M.D., Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D. study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Cheng, M.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
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.