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

Diabetes Mellitus, Type 2 Clinical Trial

— DD-Me  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130699
• Other study ID #: R01DK112322-01A1
• Status: Completed
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: August 14, 2021

Study information

• Verified date: November 2021
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: August 14, 2021
• Est. primary completion date: August 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Dulce Digital
One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Scripps Mercy Chula Vista	Chula Vista	California
United States	Scripps Whittier Diabetes Institute	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute	San Diego State University, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost Effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model		12 months
Other	Pay for Performance (P4P) Clinical Metrics		12 months
Primary	Glycosylated Hemoglobin (HbA1c); % units		12 months
Primary	Low-density lipoprotein-cholesterol (LDL-C); mg/dL units		12 months
Primary	Systolic blood pressure (SBP); mmHg units		12 months
Secondary	Patient Assessment of Chronic Illness Care (PACIC) - patient-reported outcome		12 months
Secondary	Chronic Illness Resources Survey (CIRS) - patient-reported outcome		12 months
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome		12 months
Secondary	Patient Activation Measure (PAM) - patient-reported outcome		12 months
Secondary	Adherence to Refills and Medications Scale (ARMS) - patient-reported outcome		12 months