Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19
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ClinicalTrials.gov Identifier: NCT04591015 |
Recruitment Status :
Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : January 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 Covid19 | Behavioral: Hospital: DD-CA Behavioral: Hospital: Usual Care (UC) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 172 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19 |
Estimated Study Start Date : | February 1, 2021 |
Estimated Primary Completion Date : | July 31, 2021 |
Estimated Study Completion Date : | August 31, 2021 |

Arm | Intervention/treatment |
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Experimental: 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.
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Behavioral: 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). |
Active Comparator: 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.
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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. |
- Readmission rate (30-days) [ Time Frame: 30-days ]The Electronic Medical Record (EMR) will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 30-day period by a Fisher's exact test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the primary outcome, rate of readmissions within 30-days. We do not anticipate missing data for covariates included in regression models since demographic data will be captured directly from the EMR, and baseline glycemic control (i.e. HbA1c at hospital admission) and COVID-19 diagnosis will be determined during the admission of study enrollment.
- Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 90-days, 180-days ]Additional metrics of glycemic control will be captured for each study participant from the EMR including HbA1c at 90 and 180-days post-discharge. Unadjusted group mean differences in HbA1c will be assessed with a students t-test, followed by multiple linear regression analysis controlling for baseline HbA1c (at time of initial admission), as well as covariates including gender, ethnicity, race, comorbid conditions including COVID-19, and medication/steriod use, in addition to study arm, as fixed effects in predicting HbA1c at 90 and 180 days.
- Diabetes Distress Scale [ Time Frame: Baseline, 90-days, 180-days ]Diabetes distress will be measured using the Diabetes Distress Scale (DDS); range 1-6, with higher scores indicating worse outcomes/greater diabetes-related emotional stress. The survey will be administered immediately post enrollment, prior to randomizing, and during the 90 and 180-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
- COVID-19 Patient Survey [ Time Frame: 90-days, 180-days ]Research assistants will deliver the COVID-19 Patient Survey (PhenixToolkit) to each participant at their 90 and 180-day follow up to obtain their COVID-19 diagnosis status to determine whether any new infections occurred in the 90 and 180-day post-discharge time frame. Additional questions in the survey will be used for descriptive analyses to characterize infections. Differences in proportions of patients experiencing new infections per group (i.e. patients who were negative at discharge but had a self-reported positive test within 90 and 180 days) will be compared by Fisher's exact tests.
- Summary of Diabetes Self-Care Activities Survey [ Time Frame: Baseline, 90-days, 180-days ]Summary of Diabetes Self-Care Activities (SDSCA; range 0-7, with higher scores indicating better outcomes/greater adherence to diabetes self-management behaviors) will be administered immediately post enrollment, prior to randomizing, and during the 90 and 180-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
- PROMIS Quality of Life Scale [ Time Frame: Baseline, 90-days, 180-days ]Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 (range 0-100, with higher scores reflecting better outcomes/higher quality of life) will be administered immediately post enrollment, prior to randomizing, and during the 90 and 180-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
- Knowledge, Attitudes and Practice Toward COVID-19 Survey [ Time Frame: Baseline, 90-days, 180-days ]Knowledge, Attitudes and Practices Toward COVID-19 Survey (range 0-12, with higher scores reflecting better knowledge of COVID-19) will be administered immediately post enrollment, prior to randomizing, and during the 90 and 180-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
- Demographics Questionnaire [ Time Frame: Baseline ]Socio-Economic Status (SES), nativity, duration of US residence, Marital status, depressive symptoms and healthcare utilization will be measured immediately post enrollment, prior to randomizing.
- Readmission Rate [ Time Frame: 90-days, 180-days ]Exploratory analyses will be conducted similarly to our Primary Outcome. The EMR will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 90-day period by a Fisher's exact t-test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the exploratory outcome, rate of readmissions within 90 and 180-days.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 COVD-19 related study, or
- Do not meet all eligibility inclusion criteria.

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): NCT04591015
Contact: Athena Philis-Tsimikas, MD | 858-678-7045 | philis-tsimikas.athena@scrippshealth.org |
Principal Investigator: | Athena Philis-Tsimikas, MD | Scripps Whittier Diabetes Institute |
Responsible Party: | Scripps Whittier Diabetes Institute |
ClinicalTrials.gov Identifier: | NCT04591015 |
Other Study ID Numbers: |
3R01DK112322-05S1 ( U.S. NIH Grant/Contract ) 3R01DK112322-05S1 ( U.S. NIH Grant/Contract ) |
First Posted: | October 19, 2020 Key Record Dates |
Last Update Posted: | January 14, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Type 2 Diabetes COVID-19 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |