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Clinical Trials/NCT02049359
NCT02049359
Completed
Not Applicable

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

Campbell University, Incorporated3 sites in 1 country170 target enrollmentJanuary 2014
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Campbell University, Incorporated
Enrollment
170
Locations
3
Primary Endpoint
Change From Baseline A1C
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
March 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change From Baseline A1C

Time Frame: 12 weeks

Change in A1C from baseline

Secondary Outcomes

  • Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes(12 weeks)

Study Sites (3)

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