Overview

This trial is active, not recruiting.

Condition diabetes
Treatment texting
Sponsor Campbell University, Incorporated
Start date January 2014
End date March 2016
Trial size 170 participants
Trial identifier NCT02049359, 49

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
Care as usual; no bidirectional texting
(Experimental)
Bidirectional texting weekly for 12 weeks
texting
Bidirectional texting once weekly for 12 weeks

Primary Outcomes

Measure
Change from baseline A1C
time frame: 3 months

Secondary Outcomes

Measure
Adherence to medical appointments
time frame: 3 months
Change in A1C based on age, gender, race, type and duration of diabetes
time frame: 3 months
Time necessary to complete service implementation
time frame: 14 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Use of a Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetic Patients (SAMI TRIAL)
Principal investigator Jennifer D Smith, PharmD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Campbell University, Incorporated.