NCT01671189

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for early_phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

August 20, 2012

Last Update Submit

August 22, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Appointment Adherence Rate

    6-9 month post-enrollment

Study Arms (2)

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.

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).

Interventions

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.

SMS Appointment Reminders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Mateo Medical Center

San Mateo, California, 94403, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nadim Mahmud

    Medic Mobile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations