NCT04591015|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
172
1 country
1
Study Start
February 1, 2021
Actual (reported)Primary Completion
August 31, 2022
Actual (reported)Study Completion
August 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2020
Actual (reported)October 19, 2020
Actual (reported)February 1, 2021
Actual (reported)August 31, 2022
Actual (reported)August 31, 2022
Actual (reported)September 28, 2023
Actual (reported)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
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
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.
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.
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).
Scripps Mercy Hospital Chula Vista
Chula Vista, California, 91910, United States
Athena Philis-Tsimikas, MD
Scripps Whittier Diabetes Institute
172 participants (actual enrollment reported by the registry).
First Submitted
October 5, 2020
First Posted
October 19, 2020
Study Start
February 1, 2021
Actual (reported)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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2022
Actual (reported)Study Completion
August 31, 2022
Actual (reported)Last Updated
June 18, 2025
Results First Posted
September 28, 2023
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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