ComplianceSMSNCT01837121
a Trial of Using SMS Reminder Among Diabetic Retinopathy Patients in Rural China
A study testing the SMS reminder message in people with Compliance and Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to use a randomized controlled design to determine the impact of a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic retinopathy in rural China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compliance, Diabetic Retinopathy, SMS
- What is being tested?
- the SMS reminder message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all the diabetes patients who would like to join our study in 5 CREST 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.
- The first re-visit appointment time is outside our study period.
Trial locations and contacts
1 site in 1 country.
China1 site
Blindness Preventment and Treatment Department, Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
About this study
Official title: a Randomized Controlled Trail to Determine the Impact of a SMS Reminder Among Diabetic Retinopathy Patients in Rural China
The purpose of this study is to use a randomized controlled design to determine the impact of a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic retinopathy 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 diabetic retinopathy patients.
- Conditions
- Compliance, Diabetic Retinopathy, SMS
- Being tested
- the SMS reminder message
- Keywords
- not-attended rate, re-visit, vision, knowledge, satisfaction
- Medical subject headings
- Patient Compliance, Diabetic Retinopathy, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the SMS reminder messageOther
the SMS reminder message will sent to the SMS group patients 1 week and 3 day before there appointment,to remind them the exact time and address of the revisit appointment.
| Study group | Role | What they receive |
|---|---|---|
| the SMS group | Other | the diabetic retinopathy patient in the SMS group will receive a SMS reminder message about the revisit time,address 1 week and 3 day before the appointment. Receives: Other: the SMS reminder message |
| the control group | No intervention | the diabetic retinopathy patient in the control group won't get any 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 patient not-attended rate with the control group to show the impact of SMS reminder on the compliance with scheduled follow-up visit
Measured: up to 1.5 years
Secondary outcomes (4)
Knowledge about Diabetic retinopathy on a standardized examination
Using a questionnaire about the comprehensive eye exam and Diabetic retinopathy to compare Knowledge about Diabetic retinopathy on a standardized examination between the SMS group and the control group
Measured: up to 1.5 years
Presenting vision
Presenting vision(Best corrected visual acuity) in the better-seeing and worse-seeing eyes of the two group
Measured: up to 1.5 years
Loss of presenting vision
Loss of presenting vision(Best corrected visual acuity) in better-seeing eye thought due to Diabetic retinopathy
Measured: up to 1.5 years
Satisfaction with care
Using a patient satisfaction questionnaire to compare satisfaction with care between the SMS group and the control group
Measured: up tp 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplianceStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis, The World Diabetes Foundation
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan G Congdon, MD,MPH, Study director, Blindness Prevention and Treament Department,Zhongshan Ophthalmic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837121
- Sponsor's protocol ID
- ZOC-WDF-SMS
- Acronym
- SMS
- Status last verified
- Jan 2018
- First submitted
- 14 Apr 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. 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 Among Diabetic Retinopathy Patients in Rural China
- ClinicalTrials.gov ID
- NCT01837121
- Acronym / sponsor ID
- SMS / ZOC-WDF-SMS
- Conditions
- Compliance, Diabetic Retinopathy, SMS
- Keywords
- not-attended rate, re-visit, vision, knowledge, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Orbis, The World Diabetes Foundation
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Apr 2013 (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 this study is to use a randomized controlled design to determine the impact of a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic retinopathy 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 diabetic retinopathy patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the SMS group | Other | Other: the SMS reminder messagethe diabetic retinopathy patient in the SMS group will receive a SMS reminder message about the revisit time,address 1 week and 3 day before the appointment. |
| the control group | No intervention | –the diabetic retinopathy patient in the control group won't get any reminder message before the appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all the diabetes patients who would like to join our study in 5 CREST cooperated rural hospitals.
Key exclusion criteria (2 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.
- The first re-visit appointment time is outside our study period.
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 |
|---|---|---|
| the SMS reminder messagethe SMS reminder message will sent to the SMS group patients 1 week and 3 day before there appointment,to remind them the exact time and address of the revisit appointment. | Other | the SMS group |
Primary outcome
Not-attended rate
Time frame: up to 1.5 years
Compare the SMS patient not-attended rate with the control group to show the impact of SMS reminder on the compliance with scheduled follow-up visit
4 secondary outcomes
Knowledge about Diabetic retinopathy on a standardized examination
Time frame: up to 1.5 years
Presenting vision
Time frame: up to 1.5 years
Loss of presenting vision
Time frame: up to 1.5 years
Satisfaction with care
Time frame: up tp 1.5 years
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 9 Jan 2018.
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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
Blindness Prevention and Treament Department,Zhongshan Ophthalmic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the SMS reminder message in people with Compliance and Diabetic Retinopathy, 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 1 inclusion and 2 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 9 Jan 2018. 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 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.