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Open Access 01-12-2022 | Study protocol

Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes

Authors: Athena Philis-Tsimikas, Addie L. Fortmann, Job G. Godino, James Schultz, Scott C. Roesch, Todd P. Gilmer, Emilia Farcas, Haley Sandoval, Kimberly L. Savin, Taylor Clark, Mariya Chichmarenko, Jennifer A. Jones, Linda C. Gallo

Published in: Trials | Issue 1/2022

Abstract

Background

By 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant’s individual needs with a greater focus on health behavior change.

Methods

This is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions.

Discussion

Our comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability.

Trial registration

NCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699.

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Title: Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes
Authors: Athena Philis-Tsimikas
Addie L. Fortmann
Job G. Godino
James Schultz
Scott C. Roesch
Todd P. Gilmer
Emilia Farcas
Haley Sandoval
Kimberly L. Savin
Taylor Clark
Mariya Chichmarenko
Jennifer A. Jones
Linda C. Gallo
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05899-x

2024 ASCO Annual Meeting

Springer Medicine

Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes

Abstract

Background

Methods

Discussion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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