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Dulce Digital-Project Dulce 2.0 Texting Study

NCT ID: NCT01749176

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SMS texting intervention

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Control-Usual Care

Intervention Type BEHAVIORAL

Interventions

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SMS texting intervention

Intervention Type BEHAVIORAL

Control-Usual Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McKesson Foundation

OTHER

Sponsor Role collaborator

Neighborhood Healthcare

UNKNOWN

Sponsor Role collaborator

Scripps Whittier Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Athena Philis-Tsimikas

Corporate Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athena Philis-Tsimikas, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Whittier Diabetes Institute

Locations

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Neighborhood Health

Escondido, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28600309 (View on PubMed)

Other Identifiers

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Dulce Digital

Identifier Type: -

Identifier Source: org_study_id