Diabetes
Conditions
Keywords
Diabetes
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.
Interventions
OTHERTexting
Bidirectional texting once weekly for 12 weeks
Sponsors
Campbell University, Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline A1C | 12 weeks | Change in A1C from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | 12 weeks | Change in A1C from baseline based on age, gender, race, type and duration of diabetes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Care as usual; no bidirectional texting | 69 |
| Texting Bidirectional texting weekly for 12 weeks
Texting: Bidirectional texting once weekly for 12 weeks | 56 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 19 |
Baseline characteristics
| Characteristic | Control Group | Texting | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 51 Participants | 116 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 9.7 | 52.5 years STANDARD_DEVIATION 10.3 | 51.3 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized African American | 50 Participants | 42 Participants | 92 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants | 10 Participants | 25 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 69 Participants | 56 Participants | 125 Participants |
| Sex: Female, Male Female | 41 Participants | 32 Participants | 73 Participants |
| Sex: Female, Male Male | 28 Participants | 24 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 75 |
| serious Total, serious adverse events | 0 / 95 | 0 / 75 |
Outcome results
Primary
Change From Baseline A1C
Change in A1C from baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group | Change From Baseline A1C | 1.1 percentage of A1C decrease |
| Texting | Change From Baseline A1C | 1.4 percentage of A1C decrease |
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
Time frame: 12 weeks
Population: Change in A1C percentage from baseline by demographic characteristics
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Age 18-35 | 2.1 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | 36-55 years | 1.2 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | 56-65 years | 0.5 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | >65 years | 0.8 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | African American | 1.2 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Caucasian | 1.0 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Hispanic | 2.0 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Other | 1.0 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Female | 0.9 percentage of A1C decrease |
| Control Group | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Male | 1.4 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Other | 3.0 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Age 18-35 | 1.9 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Caucasian | 1.4 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | 36-55 years | 1.4 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Male | 1.5 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | 56-65 years | 1.5 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Hispanic | 0.9 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | >65 years | 1.2 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | Female | 1.3 percentage of A1C decrease |
| Texting | Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes | African American | 1.3 percentage of A1C decrease |