Dulce Digital-Project Dulce 2.0 Texting Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Scripps Whittier Diabetes Institute
Sponsor:
Collaborators:
McKesson Foundation
Neighborhood Healthcare
Information provided by (Responsible Party):
Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01749176
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: SMS texting intervention
Behavioral: Control-Usual Care

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Scripps Whittier Diabetes Institute:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749176

Contacts
Contact: Isabel Garcia, RN, NP 858-309-2602 garcia.maria6@scrippshealth.org

Locations
United States, California
Neighborhood Health Recruiting
Escondido, California, United States
Contact: Isabel Garcia, RN, NP    858-309-2602    garcia.maria6@scrippsheatlh.org   
Sub-Investigator: James Schultz, MD         
Sponsors and Collaborators
Scripps Whittier Diabetes Institute
McKesson Foundation
Neighborhood Healthcare
Investigators
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute
  More Information

No publications provided

Responsible Party: Athena Philis-Tsimikas, Corporate Vice President, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT01749176     History of Changes
Other Study ID Numbers: Dulce Digital
Study First Received: December 11, 2012
Last Updated: December 12, 2012
Health Authority: USA: Scripps IRB & Office for the Protection of Research Subjects

Keywords provided by Scripps Whittier Diabetes Institute:
High risk Latino patients with diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014