Diabetes Mellitus Type 2 Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 300 |
| Est. completion date | December 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | San Mateo Medical Center | San Mateo | California |
| Lead Sponsor | Collaborator |
|---|---|
| Medic Mobile | San Mateo Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6-9 months post-enrollment | No |
| Secondary | 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. | 6-9 month post-enrollment | No |
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