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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Dulce Digital; Behavioral: Dulce Digital-Me (Automated Delivery); Behavioral: Dulce Digital-Me (Medical Assistant)

Detailed Description

Individuals of low socioeconomic (SES) and ethnic minority status, including Hispanics, the largest U.S. ethnic minority group, are disproportionately affected by diabetes. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, thus placing Hispanics at high risk for costly diabetes complications. The investigators' established academic-healthcare-community partnership has unique experience in developing and testing innovative, cost-effective, and sustainable chronic care interventions to reduce disparities and improve health in underserved communities. The investigators recently developed Dulce Digital (i.e., "one-size-fits-all" educational text messages, with nurse monitoring of patient-transmitted blood glucose values), which improved glycemic control across 6 months, relative to usual care in a recent randomized controlled trial (RCT) of N=126 Hispanic patients with poorly controlled type 2 diabetes (T2DM). The process evaluation for this trial indicated that Dulce Digital was both feasible and acceptable from patient and provider perspectives; however, patients expressed a preference for a more individualized intervention, and providers requested an even greater focus on health behavior change. Thus, the proposed RCT will examine the comparative effectiveness of Dulce Digital versus "Dulce Digital-Me" (DD-Me) in N=414 Hispanic adults of low SES with poorly controlled T2DM from Neighborhood Healthcare, a San Diego Federally-Qualified Health Center. Guided by patient and provider feedback, DD-Me includes Dulce Digital components plus personalized goal-setting and feedback that is responsive to the individual's needs and preferences. The DD-Me adaptive feedback component will be informed by the Resources and Support for Self-Management Model and Operant Conditioning Theory, and based on the individual's progress on intermediate behavioral targets (i.e., medication adherence assessed by wireless sensor; brief mobile phone-based assessments of diet, physical activity, stress). Feedback will be delivered via algorithm-driven automated messaging in 50% of DD-Me participants and by the care team medical assistant in the remaining half to determine the feasibility and acceptability (given the purported cultural relevance of interpersonal relationships in the Hispanic culture), and the comparative effectiveness and cost of each delivery method. Changes in indicators of diabetes clinical control [i.e., glycosylated hemoglobin (HbA1c) low density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP)], patient-provider communication, and patient adherence (i.e., to medication and other diabetes self-management behaviors) will be evaluated across twelve months. Thorough process and cost-effectiveness analyses will evaluate the scalability and sustainability potential of DD-Me. This comparative evaluation of two mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within existing nurse-led chronic care approaches to meet the complex needs of underserved individuals with poorly controlled T2DM.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91910
      • Scripps Mercy Chula Vista
    • La Jolla, California, United States, 92037
      • Scripps Whittier Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Self-identified Hispanic/Latino
2. 18 years or older
3. Registered patient of a Neighborhood Healthcare Clinic
4. Diagnosed with T2DM (Type 2 Diabetes Mellitus)
5. HbA1c ≥ 8.0% and/or SBP ≥ 160 mmHg, and/or LDL-C ≥ 100 mg/dL in the last 30 days

Exclusion Criteria:

1. Severe illness precluding regular clinic visits
2. Pregnant or lactating
3. Type 1 or gestational diabetes
4. Lack of minimal literacy
5. Plans to relocate
6. Severe auditory or visual problems
7. Primary language other than Spanish or English
8. Unwilling to carry a mobile phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Dulce Digital; 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.	Behavioral: Dulce Digital-Me (Automated Delivery); 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.	Behavioral: Dulce Digital-Me (Medical Assistant); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Systolic blood pressure (SBP); mmHg units	12 months
Glycosylated Hemoglobin (HbA1c); % units	12 months
Low-density lipoprotein-cholesterol (LDL-C); mg/dL units	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome	12 months
Patient Activation Measure (PAM) - patient-reported outcome	12 months
Patient Assessment of Chronic Illness Care (PACIC) - patient-reported outcome	12 months
Chronic Illness Resources Survey (CIRS) - patient-reported outcome	12 months
Adherence to Refills and Medications Scale (ARMS) - patient-reported outcome	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Cost Effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model	12 months
Pay for Performance (P4P) Clinical Metrics	12 months

Collaborators and Investigators

• Sponsor: Scripps Whittier Diabetes Institute
• Collaborators: San Diego State University; University of California, San Diego
• Investigators: Principal Investigator: Linda Gallo, PhD, San Diego State University

Publications and helpful links

General Publications

• Philis-Tsimikas A, Fortmann AL, Godino JG, Schultz J, Roesch SC, Gilmer TP, Farcas E, Sandoval H, Savin KL, Clark T, Chichmarenko M, Jones JA, Gallo LC. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Trials. 2022 Jan 28;23(1):80. doi: 10.1186/s13063-021-05899-x.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): August 14, 2021
• Study Completion (Actual): August 14, 2021

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; HbA1c; mHealth; T2DM; Hispanics; LDL-C; Text Messaging; Medication Adherence; Cost-Effectiveness; Automated; Systolic Blood Pressure; Self-Management Support; Medical Assistant; Adaptive Feedback; Cyberinfrastructure; Federally-Qualified Health Centers; Pay-for-Performance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: R01DK112322-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No