Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19
1 other identifier
interventional
172
1 country
1
Brief Summary
The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedResults Posted
Study results publicly available
September 28, 2023
CompletedJune 18, 2025
June 1, 2025
1.6 years
October 5, 2020
August 30, 2023
June 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Hospital Readmission Rate Within 30 Days of Discharge
Number of Participants With at Least 1 Hospital Readmission Within 30 Days After Enrollment, analyzed for full study sample
Within 30 days of discharge
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days
Change in Glycosylated Hemoglobin (HbA1c) 90 days from baseline. A negative mean indicates positive change in HbA1c.
90 days from baseline
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days
Change in Glycosylated Hemoglobin (HbA1c) 180 days from baseline. A negative mean indicates positive change in HbA1c.
180 days from baseline
Secondary Outcomes (17)
Hospital Readmission Rate Within 90 Days of Discharge
Within 90 days of discharge
Diabetes Distress Scale - Change From Baseline to 90 Days
90 days from baseline
Diabetes Distress Scale - Change From Baseline to 180 Days
180 days from baseline
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days
90 days from baseline
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days
90 days from baseline
- +12 more secondary outcomes
Study Arms (2)
DD-CA
EXPERIMENTALIn the DD-CA arm, participants will be offered a proven digital texting platform in their language of preference (Spanish/English) as part of the diabetes transitions discharge program with added COVID support messages.
Usual Care (UC)
ACTIVE COMPARATORUC participants will not receive the added COVID support messages, both arms will have a referral placed to the Diabetes Transitions Service (DTS) as part of usual care at the time of discharge.
Interventions
In the DD-CA group, participants will be offered a proven digital texting platform in their language of preference (Spanish/English) as part of the diabetes transitions discharge program with educational, motivational and medication adherence messaging that is currently an arm of our parent DD-ME grant with added COVID support messages that provide information addressing identified barriers in Hispanic underserved communities (e.g. obtaining testing supplies and medications, accessing routine medical care, and completing other important diabetes self-management behaviors such as healthful eating, exercise, social distancing, quarantine, and stay-at-home/lockdown guidelines).
In the UC group, participants will not receive the added COVID support messages, both groups will have a referral placed to the Diabetes Transitions Service (DTS) at the time of discharge as part of usual care. Participants will be contacted by a peer health coach following protocol to coordinate care with outpatient health and other community resources.
Eligibility Criteria
You may qualify if:
- Are a patient admitted to a Scripps Mercy Hospital,
- Consider yourself Hispanic/Latino, of any race
- Are 18 years of age or older,
- Speak English or Spanish,
- Have type 2 diabetes and A1c ≥ 7% in the last 90 days, and
- Have a cellphone that can receive/send text messages.
You may not qualify if:
- Are pregnant,
- Are currently participating in another diabetes or COVID-19 related study, or
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Mercy Hospital Chula Vista
Chula Vista, California, 91910, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Athena Philis-Tsimikas, MD, Co-Principal Investigator
- Organization
- Scripps Health
Study Officials
- PRINCIPAL INVESTIGATOR
Athena Philis-Tsimikas, MD
Scripps Whittier Diabetes Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Corporate Vice President
Study Record Dates
First Submitted
October 5, 2020
First Posted
October 19, 2020
Study Start
February 1, 2021
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
June 18, 2025
Results First Posted
September 28, 2023
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share