Automated SMS-Based Appointment Validation Tool
Primary Purpose
Diabetes Mellitus Type 2, Adult-onset Diabetes
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
SMS Reminder Software Tool
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus Type 2
Eligibility Criteria
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
Sites / Locations
- San Mateo Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SMS Appointment Reminders
Existing Reminder Protocol
Arm Description
150 patients will be randomly assigned to the intervention arm of the study and receive text reminders about their upcoming appointments.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01671189
First Posted
August 20, 2012
Last Updated
August 22, 2012
Sponsor
Medic Mobile
Collaborators
San Mateo Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01671189
Brief Title
Automated SMS-Based Appointment Validation Tool
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medic Mobile
Collaborators
San Mateo Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Adult-onset Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMS Appointment Reminders
Arm Type
Experimental
Arm Description
150 patients will be randomly assigned to the intervention arm of the study and receive text reminders about their upcoming appointments.
Arm Title
Existing Reminder Protocol
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
SMS Reminder Software Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic Control (hemoglobin A1c)
Description
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.
Time Frame
6-9 months post-enrollment
Secondary Outcome Measure Information:
Title
Appointment Adherence Rate
Description
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.
Time Frame
6-9 month post-enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Qu
Phone
415-728-2208
Email
jessica@medicmobile.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mainul Islam
Phone
415-328-7657
Email
mainul@medicmobile.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadim Mahmud
Organizational Affiliation
Medic Mobile
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Mateo Medical Center
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Aratow, Dr.
Email
MAratow@smcgov.org
First Name & Middle Initial & Last Name & Degree
Jeanette Aviles, Dr.
Email
javiles@smcgov.org
12. IPD Sharing Statement
Links:
URL
http://www.medicmobile.org
Description
Medic Mobile
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Automated SMS-Based Appointment Validation Tool
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