Dulce Digital-Project Dulce 2.0 Texting Study

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749176
• Other study ID #: Dulce Digital
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: November 17, 2014
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: Scripps IRB & Office for the Protection of Research Subjects
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• SMS texting intervention

• Control-Usual Care

Locations

Country	Name	City	State
United States	Neighborhood Health	Escondido	California

Sponsors (3)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute	McKesson Foundation, Neighborhood Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		6 months	No