Clinical trial NCT03130699: Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
Official title: Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
mHealth
Medical Assistant
Automated
Adaptive Feedback
Self-Management Support
Hispanics
HbA1c
Cyberinfrastructure
Federally-Qualified Health Centers
Cost-Effectiveness
T2DM
Pay-for-Performance
Medication Adherence
LDL-C
Systolic Blood Pressure
Text Messaging
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: San Diego State University
First posted: 2017-04-26
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c); % units
timeFrame: 12 months
measure: Low-density lipoprotein-cholesterol (LDL-C); mg/dL units
timeFrame: 12 months
measure: Systolic blood pressure (SBP); mmHg units
timeFrame: 12 months
Secondary outcomes:
measure: Patient Assessment of Chronic Illness Care (PACIC) - patient-reported outcome
timeFrame: 12 months
measure: Chronic Illness Resources Survey (CIRS) - patient-reported outcome
timeFrame: 12 months
measure: Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome
timeFrame: 12 months
measure: Patient Activation Measure (PAM) - patient-reported outcome
timeFrame: 12 months
measure: Adherence to Refills and Medications Scale (ARMS) - patient-reported outcome
timeFrame: 12 months
Other outcomes:
measure: Cost Effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model
timeFrame: 12 months
measure: Pay for Performance (P4P) Clinical Metrics
timeFrame: 12 months
Locations:
city: Chula Vista
country: United States
facility: Scripps Mercy Chula Vista
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Linda Gallo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.