ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03130699
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : November 8, 2018
Sponsor:
Collaborators:
University of California, San Diego
San Diego State University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Dulce Digital Behavioral: Dulce Digital-Me (Automated Delivery) Behavioral: Dulce Digital-Me (Medical Assistant) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

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.




Primary Outcome Measures :
  1. Glycosylated Hemoglobin (HbA1c); % units [ Time Frame: 12 months ]
  2. Low-density lipoprotein-cholesterol (LDL-C); mg/dL units [ Time Frame: 12 months ]
  3. Systolic blood pressure (SBP); mmHg units [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Patient Assessment of Chronic Illness Care (PACIC) - patient-reported outcome [ Time Frame: 12 months ]
  2. Chronic Illness Resources Survey (CIRS) - patient-reported outcome [ Time Frame: 12 months ]
  3. Morisky Medication Adherence Scale (MMAS) - patient-reported outcome [ Time Frame: 12 months ]
  4. Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome [ Time Frame: 12 months ]
  5. Patient Activation Measure (PAM) - patient-reported outcome [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Cost Effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model [ Time Frame: 12 months ]
  2. Pay for Performance (P4P) Clinical Metrics [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130699


Contacts
Contact: Athena Philis-Tsimikas, MD 858-678-7046 philis-tsimikas.athena@scrippshealth.org
Contact: Addie Fortmann, PhD 858-678-7097 fortmann.adelaide@scrippshealth.org

Locations
United States, California
Scripps Mercy Chula Vista Recruiting
Chula Vista, California, United States, 91910
Contact: Athena Philis-Tsimikas, MD       philis-tsimikas.athena@scrippshealth.org   
Contact: Addie Fortmann, PhD       fortmann.addie@scrippshealth.org   
Scripps Whittier Diabetes Institute Recruiting
La Jolla, California, United States, 92037
Contact: Athena Philis-Tsimikas, MD    858-678-7046    Philis-Tsimikas.Athena@scrippshealth.org   
Contact: Addie Fortmann, Ph.D.    (858) 678-7097    fortmann.adelaide@scrippshealth.org   
Principal Investigator: Athena Philis-Tsimikas, MD         
Sub-Investigator: Addie Fortmann, Ph.D.         
Sponsors and Collaborators
Scripps Whittier Diabetes Institute
University of California, San Diego
San Diego State University
Investigators
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute
Study Director: Addie Fortmann, PhD Scripps Whittier Diabetes Institute

Responsible Party: Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT03130699     History of Changes
Other Study ID Numbers: R01DK112322-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scripps Whittier Diabetes Institute:
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases