GlaucomaNCT02328456
Effect of SMS Reminder and Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
A study testing SMS and free eye drops in people with Glaucoma and Adherence, run by Congdon Nathan at 1 site in China.
Trial summary
The purpose of the study is to use a randomized controlled design to determine the impact of a SMS messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural China. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- SMS and free eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Nov 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All the patients after trabeculectomy surgery in 4 cooperated rural hospitals
Who cannot join
- Both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the SMS function.
Trial locations and contacts
1 site in 1 country.
China1 site
Blindness Preventment and Treatment Department
Guangzhou, Guangdong, 510060
About this study
Official title: A Randomized Controlled Trail to Determine the Impact of a SMS Reminder Associated With Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
The purpose of the study is to use a randomized controlled design to determine the impact of a SMS messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural China.
Read the detailed description
SMS message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. The investigators can use the SMS system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural patients.
- Being tested
- SMS and free eye drops
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS and free eye dropsOther
The SMS reminder message will sent to the SMS associated with free eye drops group patients 1 week and 1 day before there appointment to remind them the exact time and address of the revisit appointment.The eye drops will be offered free to the the SMS associated with free eye drops group patients when they revisit on time.
| Study group | Role | What they receive |
|---|---|---|
| SMS and free eye drops group | Other | the patient after trabeculectomy surgery in the SMS associated with free eye drops group will receive free eye drops and a SMS reminder message about the revisit time. Receives: Other: SMS and free eye drops |
| the control group | No intervention | the patient after trabeculectomy surgery in the control group won't get any free eye drop and reminder message before the appointment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Not-attended rate
Compare the SMS and free eye drops patient not-attend rate with the control group to show the impact of SMS reminder associated with free eye drops on the adherence with scheduled follow-up visit
Measured: up to 1 year
Secondary outcomes (2)
Knowledge and Attitudes about glaucoma, glaucoma surgery and importance of follow-up using a questionnaire
Using a questionnaire to compare Knowledge and Attitude between the SMS associated with free eye drops group and the control group
Measured: up to 1 year
Additional factors potentially associated with post-operative follow-up using a patient questionnaire
Using a patient questionnaire to compare between the SMS associated with free eye drops group and the control group
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Congdon Nathan
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis
- Responsible party
- Sponsor-investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan G Congdon, MD,MPH, Study director, China,Guangdong,Blindness Preventment and Treatment Department,Zhongshan Ophthalmic Center,510060
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328456
- Sponsor's protocol ID
- ZOC-CREST-COMPLIANCE-GLAUCOMA
- Status last verified
- Apr 2016
- First submitted
- 23 Dec 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yang K, Jin L, Li L, Zeng S, Wei R, Li G, Man P, Congdon N. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1135-1141. doi: 10.1001/jamaophthalmol.2016.2819.
PubMed 27541442
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trail to Determine the Impact of a SMS Reminder Associated With Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
- ClinicalTrials.gov ID
- NCT02328456
- Acronym / sponsor ID
- ZOC-CREST-COMPLIANCE-GLAUCOMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Congdon NathanUniversity, hospital or other
- Collaborators
- Orbis
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 Dec 2014 (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.
The purpose of the study is to use a randomized controlled design to determine the impact of a SMS messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural China.
Detailed description
SMS message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. The investigators can use the SMS system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS and free eye drops group | Other | Other: SMS and free eye dropsthe patient after trabeculectomy surgery in the SMS associated with free eye drops group will receive free eye drops and a SMS reminder message about the revisit time. |
| the control group | No intervention | –the patient after trabeculectomy surgery in the control group won't get any free eye drop and reminder message before the appointment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients after trabeculectomy surgery in 4 cooperated rural hospitals
Key exclusion criteria (1 listed)
- Both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the SMS function.
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 |
|---|---|---|
| SMS and free eye dropsThe SMS reminder message will sent to the SMS associated with free eye drops group patients 1 week and 1 day before there appointment to remind them the exact time and address of the revisit appointment.The eye drops will be offered free to the the SMS associated with free eye drops group patients when they revisit on time. | Other | SMS and free eye drops group |
Primary outcome
Not-attended rate
Time frame: up to 1 year
Compare the SMS and free eye drops patient not-attend rate with the control group to show the impact of SMS reminder associated with free eye drops on the adherence with scheduled follow-up visit
2 secondary outcomes
Knowledge and Attitudes about glaucoma, glaucoma surgery and importance of follow-up using a questionnaire
Time frame: up to 1 year
Additional factors potentially associated with post-operative follow-up using a patient questionnaire
Time frame: up to 1 year
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 15 Apr 2016.
- Derived from this study: PubMed 27541442Yang K, Jin L, Li L, Zeng S, Wei R, Li G, Man P, Congdon N. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1135-1141. doi: 10.1001/jamaophthalmol.2016.2819.
- Individual participant dataSharing planned: No
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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.
Nathan G Congdon, MD,MPH study director
China,Guangdong,Blindness Preventment and Treatment Department,Zhongshan Ophthalmic Center,510060
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS and free eye drops in people with Glaucoma and Adherence, run by Congdon Nathan 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 1 inclusion and 1 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 15 Apr 2016. 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?
Not-attended rate (time frame: up to 1 year). 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 NCT02328456, which also lists 1 linked publication.
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 15 Apr 2016.