Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19

NCT ID: NCT04591015

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-08-31

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.

Detailed Description

Hispanics, a group that shows higher type 2 diabetes (T2D) prevalence, and poor self-management and clinical outcomes, have been disproportionally adversely impacted by COVID-19. The California Department of Public Health reports that Hispanics make up 39% of California's population but an unprecedented 57% of the confirmed COVID-19 cases. This devastating finding is especially notable on the US/Mexico border. Diabetes has emerged as a leading risk factor for severe COVID-19 illness leading to hospitalization, is associated with greater disease severity and mortality and is an independent predictor of intensive care placement and invasive ventilation. It is becoming increasingly clear that maintaining good glucose control improves prognosis of COVID-19 among people with pre-existing T2D. However, social distancing, quarantine, and stay-at-home/lockdown guidelines may impact one's ability to maintain adequate glycemic control. Research is needed to evaluate the effect and clinical outcomes of a flexible, easily adopted low cost digital intervention that improves glucose excursions and provides urgently needed COVID-19 mitigation strategies, among rapidly rising groups of high-risk Hispanics with poorly controlled T2D in US/Mexico border communities. Strong evidence from our parent grant Dulce Digital-Me (DD-ME), supports the use of technology (such as text messaging) alone or in combination with coaching interventions as a viable and desired method of delivering tailored diabetes self-management education and COVID awareness messaging to high-risk, underserved populations in a manner that is more convenient for both patients and staff while having the added benefit of being cost-effective for health systems, especially within low resource settings. However, effective interventions may encounter barriers which preclude guaranteed success upon implementation in the real world. This project, taking place along the San Diego/Tijuana border, historically the busiest land port of entry in the Western Hemisphere, will assess the effect of providing an enhanced digital texting intervention-Dulce Digital-COVID Aware (DD-CA) to N = 172 Hispanic patients with T2D upon discharge from a recent hospitalization. Key outcomes will assess the impact of DD-CA on hospital readmissions at 30, 90 and 180 days post-discharge, glucose control and patient reported outcomes at 90 and 180 days post-discharge while also assessing COVID status and the implementation process. Given that DD-CA offers the potential to address many of the practical barriers to access and extend the reach of diabetes services, while additionally providing COVID awareness support, it offers an ideal low-cost and flexible solution to reduce hospital admissions and re-admissions in US/Mexico border communities significantly and simultaneously affected by COVID-19 and T2D. Implemented in a typical hospital and post-discharge setting, it augments existing care team processes, thus providing a valuable test of real-world effectiveness. More importantly, by helping to reduce existing inequities in access to diabetes and COVID-19 care, this program aims to improve health outcomes on a larger scale.

Conditions

Diabetes Mellitus, Type 2; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

DD-CA

In 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.

Group Type: EXPERIMENTAL

Hospital: DD-CA

Intervention Type: BEHAVIORAL

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).

Usual Care (UC)

UC 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.

Group Type: ACTIVE_COMPARATOR

Hospital: Usual Care (UC)

Intervention Type: BEHAVIORAL

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.

Interventions

Hospital: DD-CA

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).

Intervention Type: BEHAVIORAL

Hospital: Usual Care (UC)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Are pregnant,
• Are currently participating in another diabetes or COVID-19 related study, or

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Scripps Whittier Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Athena Philis-Tsimikas

Corporate Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Athena Philis-Tsimikas, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Whittier Diabetes Institute

Locations

Scripps Mercy Hospital Chula Vista

Chula Vista, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

3R01DK112322-05S1

Identifier Type: NIH

Identifier Source: secondary_id

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3R01DK112322-05S1

Identifier Type: NIH

Identifier Source: org_study_id

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