Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics (SAMI)

Use of a Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetic Patients (SAMI TRIAL)

The purpose of this study is to determine the impact of two-way short message service (SMS) on glycemic control in low-income, poorly-controlled adult diabetic patients.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Texting

Detailed Description

This multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum hemoglobin A1C >9% and who currently own a mobile device with text messaging capacity. After written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. Participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. Participants will be asked to respond with a simple text within 7 days. The intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the Health Center PLUS a unidirectional text message two business days prior to scheduled health center appointments. Control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. All participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. At the three month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and medication changes will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Elm City, North Carolina, United States, 27822
      • Harvest Family Health Center
    • Tarboro, North Carolina, United States, 27886
      • Freedom Hill Community Health Center
    • Wilson, North Carolina, United States, 27893
      • Wilson Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• New or existing patient of Carolina Family Health Centers Inc. (Wilson Community Health Center, Harvest Family Health Center, Freedom Hill Community Health Center)
• Diagnosis of diabetes
• Single serum hemoglobin A1C equal to or greater than 9% within 2 weeks of study enrollment
• Below 200% of 2013 poverty level
• Currently own a mobile device with text messaging capacity and anticipated service for duration of 12 week study period

Exclusion Criteria:

• Anemia diagnosed within past 3 months
• Blood transfusion within the past 3 months
• unable to read English at the fifth grade level

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Care as usual; no bidirectional texting
Experimental: Texting; Bidirectional texting weekly for 12 weeks	Other: Texting; Bidirectional texting once weekly for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline A1C	Change in A1C from baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes	Change in A1C from baseline based on age, gender, race, type and duration of diabetes	12 weeks

Collaborators and Investigators

• Sponsor: Campbell University, Incorporated
• Investigators: Principal Investigator: Jennifer D Smith, PharmD, Campbell University/Wilson Community Health Center; Study Director: Richard Drew, PharmD, Campbell University/Duke University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimated): January 30, 2014

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes
• Other Study ID Numbers: 49