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

Primary Purpose

Diabetes Mellitus, Type 2, Covid19

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hospital: DD-CA
Hospital: Usual Care (UC)
Sponsored by
Scripps Whittier Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Mercy Hospital Chula Vista

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DD-CA

Usual Care (UC)

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Hospital Readmission Rate Within 90 Days of Discharge
Number of Participants With at Least 1 Hospital Readmission Within 90 Days After Enrollment, analyzed for full study sample.
Diabetes Distress Scale - Change From Baseline to 90 Days
Diabetes distress as reported by patient; 90 days from baseline. The minimum score is 1 and maximum score is 6 with a higher score representing worse outcome or greater diabetes related emotional stress. A negative mean indicates a positive change in the diabetes distress score.
Diabetes Distress Scale - Change From Baseline to 180 Days
Diabetes distress as reported by patient; 180 days from baseline. The minimum score is 1 and maximum score is 6 with a higher score representing worse outcome or greater diabetes-related emotional stress. A negative mean indicates a positive change in the diabetes distress score.
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days
Diabetes self-care activities related to Diet as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes diet self-management behaviors. A positive mean indicates a positive change in the diet self-care activities.
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days
Diabetes self-care activities related to Exercise as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes exercise self-management behaviors. A positive mean indicates a positive change in exercise self-care activities.
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days
Diabetes self-care activities related to Blood Sugar as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes blood sugar self-management behaviors. A positive mean indicates a positive change in blood sugar self-care activities.
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days
Diabetes self-care activities related to Diet as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes diet self-management behaviors. A positive mean indicates a positive change in diet self-care activities.
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days
Diabetes self-care activities related to Exercise as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes exercise self-management behaviors. A positive mean indicates a positive change in exercise self-care activities.
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days
Diabetes self-care activities related to Blood Sugar as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes blood sugar self-management behaviors. A positive mean indicates a positive change in blood sugar self-care activities.
COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge
COVID-19 Patient Survey was used to assess COVID-19 diagnosis status and determine whether new infections occurred in the 90-day post-discharge time frame.
COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge
COVID-19 Patient Survey was used to assess COVID-19 diagnosis status and determine whether new infections occurred in the 180-day post-discharge time frame.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported physical health collected at baseline and 90 days. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 90 days, a positive mean indicates a better outcome/higher quality of life.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported mental health 90 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 90 days, a positive mean indicates a better outcome/higher quality of life and a negative mean indicates a worse outcome/lower quality of life.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported physical health 180 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 180 days, a positive mean indicates a better outcome/higher quality of life.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported mental health 180 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 180 days, a positive mean indicates a better outcome/higher quality of life, and a negative mean indicates a worse outcome/lower quality of life.
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days
Knowledge, Attitudes and Practice Toward COVID-19 Survey was used to measure knowledge and attitudes related to COVID-19 at 90 days from baseline. The minimum score on this scale is 0 and maximum score is 12, with higher scores indicating greater knowledge of COVID-19. A negative mean indicates lesser knowledge of COVID-19.
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days
Knowledge, Attitudes and Practice Toward COVID-19 Survey was used to measure knowledge and attitudes related to COVID-19 at 180 days from baseline. The minimum score on this scale is 0 and maximum score is 12, with higher scores indicating greater knowledge of COVID-19. A negative mean indicates lesser knowledge of COVID-19.

Full Information

First Posted
October 5, 2020
Last Updated
August 30, 2023
Sponsor
Scripps Whittier Diabetes Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04591015
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Whittier Diabetes Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Covid19
Keywords
Type 2 Diabetes, COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DD-CA
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care (UC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hospital: DD-CA
Intervention Description
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
Intervention Name(s)
Hospital: Usual Care (UC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Readmission Rate Within 30 Days of Discharge
Description
Number of Participants With at Least 1 Hospital Readmission Within 30 Days After Enrollment, analyzed for full study sample
Time Frame
Within 30 days of discharge
Title
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days
Description
Change in Glycosylated Hemoglobin (HbA1c) 90 days from baseline. A negative mean indicates positive change in HbA1c.
Time Frame
90 days from baseline
Title
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days
Description
Change in Glycosylated Hemoglobin (HbA1c) 180 days from baseline. A negative mean indicates positive change in HbA1c.
Time Frame
180 days from baseline
Secondary Outcome Measure Information:
Title
Hospital Readmission Rate Within 90 Days of Discharge
Description
Number of Participants With at Least 1 Hospital Readmission Within 90 Days After Enrollment, analyzed for full study sample.
Time Frame
Within 90 days of discharge
Title
Diabetes Distress Scale - Change From Baseline to 90 Days
Description
Diabetes distress as reported by patient; 90 days from baseline. The minimum score is 1 and maximum score is 6 with a higher score representing worse outcome or greater diabetes related emotional stress. A negative mean indicates a positive change in the diabetes distress score.
Time Frame
90 days from baseline
Title
Diabetes Distress Scale - Change From Baseline to 180 Days
Description
Diabetes distress as reported by patient; 180 days from baseline. The minimum score is 1 and maximum score is 6 with a higher score representing worse outcome or greater diabetes-related emotional stress. A negative mean indicates a positive change in the diabetes distress score.
Time Frame
180 days from baseline
Title
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days
Description
Diabetes self-care activities related to Diet as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes diet self-management behaviors. A positive mean indicates a positive change in the diet self-care activities.
Time Frame
90 days from baseline
Title
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days
Description
Diabetes self-care activities related to Exercise as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes exercise self-management behaviors. A positive mean indicates a positive change in exercise self-care activities.
Time Frame
90 days from baseline
Title
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days
Description
Diabetes self-care activities related to Blood Sugar as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes blood sugar self-management behaviors. A positive mean indicates a positive change in blood sugar self-care activities.
Time Frame
90 days from baseline
Title
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days
Description
Diabetes self-care activities related to Diet as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes diet self-management behaviors. A positive mean indicates a positive change in diet self-care activities.
Time Frame
180 days from baseline
Title
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days
Description
Diabetes self-care activities related to Exercise as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes exercise self-management behaviors. A positive mean indicates a positive change in exercise self-care activities.
Time Frame
180 days from baseline
Title
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days
Description
Diabetes self-care activities related to Blood Sugar as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes blood sugar self-management behaviors. A positive mean indicates a positive change in blood sugar self-care activities.
Time Frame
180 days from baseline
Title
COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge
Description
COVID-19 Patient Survey was used to assess COVID-19 diagnosis status and determine whether new infections occurred in the 90-day post-discharge time frame.
Time Frame
Within 90 days of discharge
Title
COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge
Description
COVID-19 Patient Survey was used to assess COVID-19 diagnosis status and determine whether new infections occurred in the 180-day post-discharge time frame.
Time Frame
Within 180 days of discharge
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported physical health collected at baseline and 90 days. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 90 days, a positive mean indicates a better outcome/higher quality of life.
Time Frame
90 days from baseline
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported mental health 90 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 90 days, a positive mean indicates a better outcome/higher quality of life and a negative mean indicates a worse outcome/lower quality of life.
Time Frame
90 days from baseline
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported physical health 180 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 180 days, a positive mean indicates a better outcome/higher quality of life.
Time Frame
180 days from baseline
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported mental health 180 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 180 days, a positive mean indicates a better outcome/higher quality of life, and a negative mean indicates a worse outcome/lower quality of life.
Time Frame
180 days from baseline
Title
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days
Description
Knowledge, Attitudes and Practice Toward COVID-19 Survey was used to measure knowledge and attitudes related to COVID-19 at 90 days from baseline. The minimum score on this scale is 0 and maximum score is 12, with higher scores indicating greater knowledge of COVID-19. A negative mean indicates lesser knowledge of COVID-19.
Time Frame
90 days from baseline
Title
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days
Description
Knowledge, Attitudes and Practice Toward COVID-19 Survey was used to measure knowledge and attitudes related to COVID-19 at 180 days from baseline. The minimum score on this scale is 0 and maximum score is 12, with higher scores indicating greater knowledge of COVID-19. A negative mean indicates lesser knowledge of COVID-19.
Time Frame
180 days from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Philis-Tsimikas, MD
Organizational Affiliation
Scripps Whittier Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Mercy Hospital Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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