Clinical trial NCT04591015: Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19
Official title: Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Covid19
Keywords: Type 2 Diabetes
COVID-19
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-10-19
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* Do not meet all eligibility inclusion criteria.

Primary outcomes:
measure: Hospital Readmission Rate Within 30 Days of Discharge
timeFrame: Within 30 days of discharge
measure: Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days
timeFrame: 90 days from baseline
measure: Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days
timeFrame: 180 days from baseline
Secondary outcomes:
measure: Hospital Readmission Rate Within 90 Days of Discharge
timeFrame: Within 90 days of discharge
measure: Diabetes Distress Scale - Change From Baseline to 90 Days
timeFrame: 90 days from baseline
measure: Diabetes Distress Scale - Change From Baseline to 180 Days
timeFrame: 180 days from baseline
measure: Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days
timeFrame: 90 days from baseline
measure: Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days
timeFrame: 90 days from baseline
measure: Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days
timeFrame: 90 days from baseline
measure: Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days
timeFrame: 180 days from baseline
measure: Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days
timeFrame: 180 days from baseline
measure: Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days
timeFrame: 180 days from baseline
measure: COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge
timeFrame: Within 90 days of discharge
measure: COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge
timeFrame: Within 180 days of discharge
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days
timeFrame: 90 days from baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days
timeFrame: 90 days from baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days
timeFrame: 180 days from baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days
timeFrame: 180 days from baseline
measure: Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days
timeFrame: 90 days from baseline
measure: Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days
timeFrame: 180 days from baseline
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Scripps Mercy Hospital Chula Vista
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References: