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

• ClinicalTrials.gov Identifier: NCT04591015
• Recruitment Status: Not yet recruiting
• First Posted: October 19, 2020
• Last Update Posted: January 14, 2021
• Sponsor: Scripps Whittier Diabetes Institute
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Scripps Whittier Diabetes Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Covid19	Behavioral: Hospital: DD-CA; Behavioral: Hospital: Usual Care (UC)	Phase 3

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 COVD-19 related study, or
• Do not meet all eligibility inclusion criteria.

Contacts and Locations

Contacts

Contact: Athena Philis-Tsimikas, MD; 858-678-7045; philis-tsimikas.athena@scrippshealth.org

Sponsors and Collaborators

Scripps Whittier Diabetes Institute

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

Investigators

• Principal Investigator: Athena Philis-Tsimikas, MD; Scripps Whittier Diabetes Institute

More Information

• 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
• 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

Keywords provided by Scripps Whittier Diabetes Institute:

Type 2 Diabetes; COVID-19

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases