Clinical trial NCT01749176: Dulce Digital-Project Dulce 2.0 Texting Study
Official title: Dulce Digital-Project Dulce 2.0 Texting Study in High Risk Latinos With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: High risk Latino patients with diabetes
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: McKesson Foundation
name: Neighborhood Healthcare
First posted: 2012-12-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Neighborhood Health
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fortmann AL, Gallo LC, Garcia MI, Taleb M, Euyoque JA, Clark T, Skidmore J, Ruiz M, Dharkar-Surber S, Schultz J, Philis-Tsimikas A. Dulce Digital: An mHealth SMS-Based Intervention Improves Glycemic Control in Hispanics With Type 2 Diabetes. Diabetes Care. 2017 Oct;40(10):1349-1355. doi: 10.2337/dc17-0230. Epub 2017 Jun 9.