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)
1 other identifier
interventional
170
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Jan 2014
Typical duration for not_applicable diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
July 3, 2023
CompletedJuly 3, 2023
August 1, 2022
2.2 years
January 28, 2014
July 18, 2017
August 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline A1C
Change in A1C from baseline
12 weeks
Secondary Outcomes (1)
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
12 weeks
Study Arms (2)
Control group
NO INTERVENTIONCare as usual; no bidirectional texting
Texting
EXPERIMENTALBidirectional texting weekly for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Anemia diagnosed within past 3 months
- Blood transfusion within the past 3 months
- unable to read English at the fifth grade level
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Harvest Family Health Center
Elm City, North Carolina, 27822, United States
Freedom Hill Community Health Center
Tarboro, North Carolina, 27886, United States
Wilson Community Health Center
Wilson, North Carolina, 27893, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Smith
- Organization
- Campbell University
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer D Smith, PharmD
Campbell University/Wilson Community Health Center
- STUDY DIRECTOR
Richard Drew, PharmD
Campbell University/Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2014
First Posted
January 30, 2014
Study Start
January 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
July 3, 2023
Results First Posted
July 3, 2023
Record last verified: 2022-08