Dulce Digital-Project Dulce 2.0 Texting Study

Study Overview
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Brief Summary
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Randomized controlled trial testing the efficacy of a text messaging intervention in a low income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will address barriers to participation in health education classes, increasing adherence to treatment and medications and improving diabetes self management behaviors and skills. Two community clinic organizations that provide services to a large proportion of Latino patients with type 2 diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes management care (control) only or text messaging and standard care. Comparisons between groups will evaluate clinical, behavioral and psychosocial outcomes. Intervention: Standard Care and Text Messaging. All participants will receive standard diabetes care provided by primary care providers at the clinic. Of the 100 that are randomized to the intervention arm will be given instructions on how the text messaging component will be addressed throughout the duration of the study.

Official Title
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Dulce Digital-Project Dulce 2.0 Texting Study in High Risk Latinos With Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: SMS texting intervention
* Behavioral: Control-Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-75, Type 2 DM, Enrolled at community health center, Latino ethnicity, non Project Dulce participant, HbA1c>/= 8%, must be able to read Exclusion Criteria: Have a severe illness precluding frequent visits to the clinic, have a severe medical condition, poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study, any history of malignancy, except subjects who have been disease-free for >10 years, or whose only malignancy has been basal or squamous cell skin carcinoma, patients who have a creatinine level greater than 3.5, any history of drug or alcohol abuse within 12 months prior to the study, those who are not a permanent resident in the area. Patients who are not willing to use a cell phone with texting capability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS texting intervention<br>Behavioral text messages will be sent at random times throughout the week reagarding Healthy nutrition tips, benefits of physical activity, benefits of medication adherence and requests to check blood sugar and send back results. | Behavioral: SMS texting intervention<br> <br> |
| Placebo Comparator: Control-Usual Care<br>Participants will continue to receive their usual care in their primary care home. They will return at months 3 and 6 to conduct behavioral and laboratory assessments to compare results with the intervention group. | Behavioral: Control-Usual Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High risk Latino patients with diabetes