Dulce Digital-Project Dulce 2.0 Texting Study

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: SMS texting intervention; Behavioral: Control-Usual Care

• Registration Number: NCT01749176
• Lead Sponsor: Scripps Whittier Diabetes Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMS texting intervention	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.
Control-Usual Care	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.

Primary Outcome Measures

Name	Time	Method
HbA1c	6 months

Trial Locations

Locations (1)

Neighborhood Health; 🇺🇸 Escondido, California, United States