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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Care as usual; no bidirectional texting | |
| Texting | Experimental | Bidirectional texting weekly for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Texting | Other | Bidirectional texting once weekly for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline A1C | Change in A1C from baseline | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer D Smith, PharmD | Campbell University/Wilson Community Health Center | Principal Investigator |
| Richard Drew, PharmD | Campbell University/Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvest Family Health Center | Elm City | North Carolina | 27822 | United States | ||
| Freedom Hill Community Health Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Care as usual; no bidirectional texting |
| FG001 | Texting | Bidirectional texting weekly for 12 weeks Texting: Bidirectional texting once weekly for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Care as usual; no bidirectional texting |
| BG001 | Texting | Bidirectional texting weekly for 12 weeks Texting: Bidirectional texting once weekly for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline A1C | Change in A1C from baseline | Posted | Mean | 95% Confidence Interval | percentage of A1C decrease | 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Care as usual; no bidirectional texting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Smith | Campbell University | 2522439800 | 224 | jsmith@cfhcnc.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Tarboro |
| North Carolina |
| 27886 |
| United States |
| Wilson Community Health Center | Wilson | North Carolina | 27893 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 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 | Change in A1C percentage from baseline by demographic characteristics | Posted | Mean | 95% Confidence Interval | percentage of A1C decrease | 12 weeks |
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| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Texting | Bidirectional texting weekly for 12 weeks Texting: Bidirectional texting once weekly for 12 weeks | 0 | 75 | 0 | 75 |
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| 36-55 years |
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| 56-65 years |
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| >65 years |
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| African American |
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| Caucasian |
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| Hispanic |
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| Other |
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| Female |
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| Male |
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