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 — BEHAVIORALOne-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
- Dulce Digital-Me (Automated Delivery) — BEHAVIORALEducational 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) — BEHAVIORALEducational 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 DigitalThe 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)
| Facility | City | State | ZIP |
|---|---|---|---|
| Scripps Mercy Chula Vista | Chula Vista | California | 91910 |
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 |
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