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Dulce Digital-Project Dulce 2.0 Texting Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01749176
First Posted: December 13, 2012
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
McKesson Foundation
Neighborhood Healthcare
Information provided by (Responsible Party):
Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Dulce Digital-Project Dulce 2.0 Texting Study in High Risk Latinos With Diabetes

Further study details as provided by Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 6 months ]

Enrollment: 126
Study Start Date: October 2012
Study Completion Date: October 2014
Primary Completion Date: September 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749176


Locations
United States, California
Neighborhood Health
Escondido, California, United States
Sponsors and Collaborators
Scripps Whittier Diabetes Institute
McKesson Foundation
Neighborhood Healthcare
Investigators
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute
  More Information

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
First Submitted: December 11, 2012
First Posted: December 13, 2012
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute:
High risk Latino patients with diabetes