Dulce Digital-Project Dulce 2.0 Texting Study

November 17, 2014 updated by: Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Escondido, California, United States
        • Neighborhood Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Whittier Diabetes Institute

Collaborators

McKesson Foundation
Neighborhood Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dulce Digital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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