- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01671189
Automated SMS-Based Appointment Validation Tool
August 22, 2012 updated by: Medic Mobile
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Mateo, California, United States, 94403
- San Mateo Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMS Appointment Reminders
150 patients will be randomly assigned to the intervention arm of the study and receive text reminders about their upcoming appointments.
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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.
|
No Intervention: Existing Reminder Protocol
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Control (hemoglobin A1c)
Time Frame: 6-9 months post-enrollment
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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.
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6-9 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appointment Adherence Rate
Time Frame: 6-9 month post-enrollment
|
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.
|
6-9 month post-enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nadim Mahmud, Medic Mobile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
August 20, 2012
First Submitted That Met QC Criteria
August 22, 2012
First Posted (Estimate)
August 23, 2012
Study Record Updates
Last Update Posted (Estimate)
August 23, 2012
Last Update Submitted That Met QC Criteria
August 22, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMMC-MCK-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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