Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes

Part of paid clinical trials in Chula Vista, California.

Sponsor
Scripps Whittier Diabetes Institute
Study ID
NCT03130699
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dulce Digital — BEHAVIORAL
    One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
  • Dulce Digital-Me (Automated Delivery) — BEHAVIORAL
    Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.
  • Dulce Digital-Me (Medical Assistant) — BEHAVIORAL
    Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.

Study Details

This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile health) intervention that is tailored to individuals' needs and behavioral progress, in improving diabetes clinical control, adherence, and patient-provider communication in Hispanics - an at-risk, understudied population that experiences disparities in diabetes prevalence and outcomes. These striking disparities in the growing and aging US Hispanic population have taxed the US healthcare system, while significantly reducing quantity and quality of life for millions of individuals. By offering an innovative, scalable, and sustainable approach that seamlessly integrates several mHealth technologies into existing primary care team processes to improve the health of Hispanics (and eventually, other at-risk, underserved groups), DD-Me has strong potential to significantly impact public health.

Key Dates

Start date
Oct 31, 2017
Status verified
Jun 2025
Primary completion
Aug 14, 2021
Completion
Aug 14, 2021

Study Design

Enrollment
310 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dulce Digital
    The first of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives one-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
  • Experimental: Dulce Digital-Me (Automated Delivery)
    The second of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.
  • Experimental: Dulce Digital-Me (Medical Assistant)
    The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.

Primary Outcome Measure

Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment [ Time Frame: 6 months from baseline ]

Locations (2)

FacilityCityStateZIP
Scripps Mercy Chula VistaChula VistaCalifornia91910
Scripps Whittier Diabetes InstituteLa JollaCalifornia92037

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