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

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

Registration Number: NCT03130699

Lead Sponsor: Scripps Whittier Diabetes Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 310

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment	6 months from baseline	Glycosylated Hemoglobin (HbA1c) six months after enrollment
Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment	12 months from baseline	Glycosylated Hemoglobin (HbA1c) twelve months after enrollment
Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment	6 months from baseline	Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment
Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment	12 months from baseline	Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment
Systolic Blood Pressure (SBP); 6 Months From Enrollment	6 months from baseline	Systolic blood pressure (SBP); six months from enrollment
Systolic Blood Pressure (SBP); 12 Months From Enrollment	12 months from baseline	Systolic blood pressure (SBP); twelve months from enrollment

Secondary Outcome Measures

Name	Time	Method
Patient Blood Glucose Monitoring; 12 Months From Enrollment	12 months from baseline	Patient Blood Glucose Monitoring as reported by patient; twelve months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome.
Participated in Aerobic Exercise; 6 Months From Enrollment	6 months from baseline	Participated in Aerobic Exercise as reported by patient, six months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome.
Participated in Aerobic Exercise; 12 Months From Enrollment	12 months from baseline	Participated in Aerobic Exercise as reported by patient, twelve months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome.
Participated in Strength Exercise; 6 Months From Enrollment	6 months from baseline	Participated in Strength Exercise as reported by patient; six months from enrollment
Participated in Strength Exercise; 12 Months From Enrollment	12 months from baseline	Participated in Strength Exercise as reported by patient; twelve months from enrollment
Participated in Flexibility Exercise; 6 Months From Enrollment	6 months from baseline	Participated in Flexibility Exercise as reported by patient; six months from enrollment
Participated in Flexibility Exercise; 12 Months From Enrollment	12 months from baseline	Participated in Flexibility Exercise as reported by patient; twelve months from enrollment
Healthy Eating Behaviors; 6 Months From Enrollment	6 months from baseline	Healthy Eating Behaviors as reported by patient; six months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome.
Healthy Eating Behaviors; 12 Months From Enrollment	12 months from baseline	Healthy Eating Behaviors as reported by patient; twelve months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome.
Diabetes Distress; 6 Months From Enrollment	6 months from baseline	Diabetes Distress as reported by patient; six months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome.
Diabetes Distress; 12 Months From Enrollment	12 months from baseline	Diabetes Distress as reported by patient; twelve months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome.
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment	6 months from baseline	Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; six months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome.
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment	12 months from baseline	Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; twelve months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome.
Patient-Provider Communication; 6 Months From Enrollment	6 months from baseline	Patient-Provider Communication as reported by patient; six months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome.
Patient-Provider Communication; 12 Months From Enrollment	12 months from baseline	Patient-Provider Communication as reported by patient; twelve months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome.
Patient Blood Glucose Monitoring; 6 Months From Enrollment	6 months from baseline	Patient Blood Glucose Monitoring as reported by patient; six months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome.

Trial Locations

Locations (2): Scripps Mercy Chula Vista
🇺🇸
Chula Vista, California, United States
Scripps Whittier Diabetes Institute
🇺🇸
La Jolla, California, United States
Scripps Mercy Chula Vista
🇺🇸Chula Vista, California, United States