Dulce Digital-Project Dulce 2.0 Texting Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Dulce Digital-Project Dulce 2.0 Texting Study in High Risk Latinos With Diabetes|
- HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: SMS texting intervention
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|
Placebo Comparator: Control-Usual Care
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749176
|Contact: Isabel Garcia, RN, NPemail@example.com|
|United States, California|
|Escondido, California, United States|
|Contact: Isabel Garcia, RN, NP 858-309-2602 firstname.lastname@example.org|
|Sub-Investigator: James Schultz, MD|
|Principal Investigator:||Athena Philis-Tsimikas, MD||Scripps Whittier Diabetes Institute|