Diabetes Mellitus Type 2Early Phase 1NCT01671189
Automated SMS-Based Appointment Validation Tool
A Early Phase 1 study testing SMS Reminder Software Tool in people with Diabetes Mellitus Type 2 and Adult-onset Diabetes, run by Medic Mobile at 1 site in United States.
Trial summary
Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation tool to automate appointment confirmation and rescheduling. Working in parallel with the San Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will automate reminders that request text… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Adult-onset Diabetes
- What is being tested?
- SMS Reminder Software Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2013
- Phase
- Early Phase 1
- 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
- Belong to Willow Clinic or Fair Oaks Clinic under the San Mateo Medical Center
- Have a diagnosis of type 2 diabetes as indicated by ICD-9 code of 249.xx or 250.xx
- Have a most recent hemoglobin A1c (HbA1c) level greater than 7%
- Are at least 18 years of age
- Have access to cell phone
- Are literate or live with a friend/family member who is literate and willing to handle associated text messages
Who cannot join
- Have a terminal illness and prognosis of less than one year
- Are unable to demonstrate the ability to reply to an SMS and lack an appropriate proxy
- Are pregnant or expect to be pregnant in the next 6-9 months
Trial locations and contacts
1 site in 1 country.
United States1 site
San Mateo Medical Center
San Mateo, California, 94403
Mike Aratow, Dr., MAratow@smcgov.org
Jeanette Aviles, Dr., javiles@smcgov.org
About this study
Official title: An Automated SMS-Based Reminder and Rescheduling Tool to Improve Appointment Adherence Rates and Glycemic Control Among Diabetes Patients in San Mateo County
Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation tool to automate appointment confirmation and rescheduling. Working in parallel with the San Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. While simple in concept, this tool aims to free up scarce clinical resources which are currently allocated to daily patient phone call reminders. With funding from a Bay Area foundation, the investigators will develop and pilot this open-source software tool in a 12-month randomized-controlled trial, slated to begin in October 2012. The endpoints of the study will aim to demonstrate improvements in both appointment adherence and glycemic control.
- Conditions
- Diabetes Mellitus Type 2, Adult-onset Diabetes
- Being tested
- SMS Reminder Software Tool
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS Reminder Software ToolOther
The 150 patients in the intervention arm of the study will receive SMS reminders regarding their upcoming appointments. Working in parallel with the SMMC electronic medical records system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. This bidirectional text messaging system would not interfere with the clinics' existing reminder protocol.
| Study group | Role | What they receive |
|---|---|---|
| SMS Appointment Reminders | Experimental | 150 patients will be randomly assigned to the intervention arm of the study and receive text reminders about their upcoming appointments. Receives: Other: SMS Reminder Software Tool |
| Existing Reminder Protocol | No intervention | 150 patients will be randomly assigned to the control arm of the study and will not receive SMS reminders about their upcoming appointments. They will, however, be subject to the clinics' existing reminder protocol (phone call reminders by either clinic personnel or computer machine). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control (hemoglobin A1c)
The hemoglobin A1c (HbA1c) levels of study participants will be measured at the time of enrollment and at the end of the 6-9 month follow-up period.
Measured: 6-9 months post-enrollment
Secondary outcomes (1)
Appointment Adherence Rate
Appointments scheduled during the 6-9 month follow-up period will be systematically tracked and monitored. The proportion of fulfilled appointments will be compared between the intervention and control arms.
Measured: 6-9 month post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medic Mobile
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- San Mateo Medical Center
- Responsible party
- Sponsor
- Investigators
- Nadim Mahmud, Principal investigator, Medic Mobile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671189
- Sponsor's protocol ID
- SMMC-MCK-2012
- Status last verified
- Aug 2012
- First submitted
- 20 Aug 2012
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Automated SMS-Based Reminder and Rescheduling Tool to Improve Appointment Adherence Rates and Glycemic Control Among Diabetes Patients in San Mateo County
- ClinicalTrials.gov ID
- NCT01671189
- Acronym / sponsor ID
- SMMC-MCK-2012
- Conditions
- Diabetes Mellitus Type 2, Adult-onset Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medic MobileIndustry (pharma, biotech, devices)
- Collaborators
- San Mateo Medical Center
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Aug 2012 (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.
Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation tool to automate appointment confirmation and rescheduling. Working in parallel with the San Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. While simple in concept, this tool aims to free up scarce clinical resources which are currently allocated to daily patient phone call reminders. With funding from a Bay Area foundation, the investigators will develop and pilot this open-source software tool in a 12-month randomized-controlled trial, slated to begin in October 2012. The endpoints of the study will aim to demonstrate improvements in both appointment adherence and glycemic control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS Appointment Reminders | Experimental | Other: SMS Reminder Software Tool150 patients will be randomly assigned to the intervention arm of the study and receive text reminders about their upcoming appointments. |
| Existing Reminder Protocol | No intervention | –150 patients will be randomly assigned to the control arm of the study and will not receive SMS reminders about their upcoming appointments. They will, however, be subject to the clinics' existing reminder protocol (phone call reminders by either clinic personnel or computer machine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Belong to Willow Clinic or Fair Oaks Clinic under the San Mateo Medical Center
- Have a diagnosis of type 2 diabetes as indicated by ICD-9 code of 249.xx or 250.xx
- Have a most recent hemoglobin A1c (HbA1c) level greater than 7%
- Are at least 18 years of age
- Have access to cell phone
Key exclusion criteria (3 listed)
- Have a terminal illness and prognosis of less than one year
- Are unable to demonstrate the ability to reply to an SMS and lack an appropriate proxy
- Are pregnant or expect to be pregnant in the next 6-9 months
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 Reminder Software ToolThe 150 patients in the intervention arm of the study will receive SMS reminders regarding their upcoming appointments. Working in parallel with the SMMC electronic medical records system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. This bidirectional text messaging system would not interfere with the clinics' existing reminder protocol. | Other | SMS Appointment Reminders |
Primary outcome
Glycemic Control (hemoglobin A1c)
Time frame: 6-9 months post-enrollment
The hemoglobin A1c (HbA1c) levels of study participants will be measured at the time of enrollment and at the end of the 6-9 month follow-up period.
1 secondary outcome
Appointment Adherence Rate
Time frame: 6-9 month post-enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Medic MobileLink 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.
Nadim Mahmud principal investigator
Medic Mobile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SMS Reminder Software Tool in people with Diabetes Mellitus Type 2 and Adult-onset Diabetes, run by Medic Mobile at 1 site in United States.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Aug 2012. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Qu (415-728-2208, jessica@medicmobile.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (hemoglobin A1c) (time frame: 6-9 months post-enrollment). 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 23 Aug 2012.