Covid19, Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes, COVID-19
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.
Interventions
BEHAVIORALHospital: 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).
BEHAVIORALHospital: 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Scripps Whittier Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 COVID-19 related study, or * Do not meet all eligibility inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmission Rate Within 30 Days of Discharge | 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 | 90 days from baseline | 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 | 180 days from baseline | Change in Glycosylated Hemoglobin (HbA1c) 180 days from baseline. A negative mean indicates positive change in HbA1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days | 90 days from baseline | 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 | 90 days from baseline | 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 | 90 days from baseline | 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 | 180 days from baseline | 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 | 180 days from baseline | 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 | 180 days from baseline | 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 | 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. |
| Hospital Readmission Rate Within 90 Days of Discharge | Within 90 days of discharge | Number of Participants With at Least 1 Hospital Readmission Within 90 Days After Enrollment, analyzed for full study sample. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days | 90 days from baseline | 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 | 90 days from baseline | 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 | 180 days from baseline | 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 | 180 days from baseline | 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 | 90 days from baseline | 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 | 180 days from baseline | 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. |
| COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge | 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. |
| Diabetes Distress Scale - Change From Baseline to 90 Days | 90 days from baseline | 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 | 180 days from baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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). | 86 |
| 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.
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. | 86 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 4 |
| Overall Study | Lost to Follow-up | 16 | 11 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | DD-CA | Usual Care (UC) | Total |
|---|---|---|---|
| Age, Continuous | 54.23 years STANDARD_DEVIATION 14.2 | 61.33 years STANDARD_DEVIATION 11.24 | 57.78 years STANDARD_DEVIATION 13.26 |
| Born in Mexico | 61 Participants | 58 Participants | 119 Participants |
| Cardiometabolic Conditions | 86 Participants | 86 Participants | 172 Participants |
| Diabetes Distress Scale | 1.85 units on a scale STANDARD_DEVIATION 0.85 | 1.93 units on a scale STANDARD_DEVIATION 0.86 | 1.89 units on a scale STANDARD_DEVIATION 0.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 86 Participants | 86 Participants | 172 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Has Some Type of Health Insurance | 66 Participants | 78 Participants | 144 Participants |
| Hospital Visit Length of Stay in Days | 7.02 days STANDARD_DEVIATION 6.64 | 5.45 days STANDARD_DEVIATION 3.92 | 6.24 days STANDARD_DEVIATION 5.5 |
| Income Less than 30,000 per year | 58 Participants | 60 Participants | 118 Participants |
| Les than High School Education | 41 Participants | 39 Participants | 80 Participants |
| Married or Cohabitating | 49 Participants | 46 Participants | 95 Participants |
| Not Employed | 58 Participants | 66 Participants | 124 Participants |
| Patient Reported Outcomes Measurement Information System Global-10 Health Scale - Mental Health | 13.50 units on a scale STANDARD_DEVIATION 3.09 | 13.31 units on a scale STANDARD_DEVIATION 3.27 | 13.40 units on a scale STANDARD_DEVIATION 3.18 |
| Patient Reported Outcomes Measurement Information System Global-10 Health Scale - Physical Health | 12.41 units on a scale STANDARD_DEVIATION 3.25 | 11.98 units on a scale STANDARD_DEVIATION 3.23 | 12.19 units on a scale STANDARD_DEVIATION 3.24 |
| Primary Language is Spanish | 63 Participants | 59 Participants | 122 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 46 Participants | 49 Participants | 95 Participants |
| Race (NIH/OMB) White | 37 Participants | 32 Participants | 69 Participants |
| Region of Enrollment United States | 86 participants | 86 participants | 172 participants |
| Sex: Female, Male Female | 35 Participants | 48 Participants | 83 Participants |
| Sex: Female, Male Male | 51 Participants | 38 Participants | 89 Participants |
| Summary of Diabetes Self-Care Activities - Blood glucose testing | 2.88 units on a scale STANDARD_DEVIATION 3.21 | 4.13 units on a scale STANDARD_DEVIATION 3.12 | 3.51 units on a scale STANDARD_DEVIATION 3.21 |
| Summary of Diabetes Self-Care Activities - Diet | 4.15 units on a scale STANDARD_DEVIATION 1.92 | 4.20 units on a scale STANDARD_DEVIATION 1.62 | 4.18 units on a scale STANDARD_DEVIATION 1.78 |
| Summary of Diabetes Self-Care Activities - Excercise | 2.72 units on a scale STANDARD_DEVIATION 2.9 | 2.38 units on a scale STANDARD_DEVIATION 2.96 | 2.55 units on a scale STANDARD_DEVIATION 2.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 86 | 4 / 86 |
| other Total, other adverse events | 0 / 86 | 0 / 86 |
| serious Total, serious adverse events | 0 / 86 | 0 / 86 |
Outcome results
Primary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days | -2.03 percentage of HbA1c | Standard Deviation 2.66 |
| Usual Care (UC) | Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days | -0.91 percentage of HbA1c | Standard Deviation 2.02 |
Comparison: Only includes participants who completed a 180-day labp-value: 0.0651t-test, 2 sided
Primary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days | -2.69 percentage of HbA1c | Standard Deviation 2.53 |
| Usual Care (UC) | Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days | -1.45 percentage of HbA1c | Standard Deviation 2.04 |
Comparison: Only includes participants who completed a 90-day labp-value: 0.0496t-test, 2 sided
Primary
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
Time frame: Within 30 days of discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DD-CA | Hospital Readmission Rate Within 30 Days of Discharge | 24 Participants |
| Usual Care (UC) | Hospital Readmission Rate Within 30 Days of Discharge | 13 Participants |
p-value: 0.0626Fisher Exact
Secondary
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.
Time frame: Within 180 days of discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DD-CA | COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge | 8 Participants |
| Usual Care (UC) | COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge | 4 Participants |
p-value: 0.7417Fisher Exact
Secondary
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.
Time frame: Within 90 days of discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DD-CA | COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge | 5 Participants |
| Usual Care (UC) | COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge | 2 Participants |
p-value: 0.4435Fisher Exact
Secondary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Diabetes Distress Scale - Change From Baseline to 180 Days | -0.56 score on a scale | Standard Deviation 0.68 |
| Usual Care (UC) | Diabetes Distress Scale - Change From Baseline to 180 Days | -0.35 score on a scale | Standard Deviation 0.58 |
p-value: 0.1258t-test, 2 sided
Secondary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Diabetes Distress Scale - Change From Baseline to 90 Days | -0.42 score on a scale | Standard Deviation 0.77 |
| Usual Care (UC) | Diabetes Distress Scale - Change From Baseline to 90 Days | -0.31 score on a scale | Standard Deviation 0.69 |
p-value: 0.4702t-test, 2 sided
Secondary
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.
Time frame: Within 90 days of discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DD-CA | Hospital Readmission Rate Within 90 Days of Discharge | 32 Participants |
| Usual Care (UC) | Hospital Readmission Rate Within 90 Days of Discharge | 30 Participants |
p-value: 0.8739Fisher Exact
Secondary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days | -0.48 score on a scale | Standard Deviation 1.65 |
| Usual Care (UC) | Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days | -0.52 score on a scale | Standard Deviation 1.44 |
p-value: 0.8955t-test, 2 sided
Secondary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days | -0.64 score on a scale | Standard Deviation 1.77 |
| Usual Care (UC) | Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days | -0.29 score on a scale | Standard Deviation 1.26 |
p-value: 0.2404t-test, 2 sided
Secondary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days | 0.81 score on a scale | Standard Deviation 3 |
| Usual Care (UC) | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days | -0.21 score on a scale | Standard Deviation 2.82 |
p-value: 0.0921t-test, 2 sided
Secondary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days | 0.91 score on a scale | Standard Deviation 2.74 |
| Usual Care (UC) | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days | -0.16 score on a scale | Standard Deviation 2.92 |
p-value: 0.0493t-test, 2 sided
Secondary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days | 1.59 score on a scale | Standard Deviation 3.33 |
| Usual Care (UC) | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days | 0.38 score on a scale | Standard Deviation 3.37 |
p-value: 0.0773t-test, 2 sided
Secondary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days | 0.87 score on a scale | Standard Deviation 2.73 |
| Usual Care (UC) | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days | 0.55 score on a scale | Standard Deviation 3.21 |
p-value: 0.5779t-test, 2 sided
Secondary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days | 2.38 score on a scale | Standard Deviation 3.19 |
| Usual Care (UC) | Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days | 0.76 score on a scale | Standard Deviation 3.41 |
p-value: 0.0175t-test, 2 sided
Secondary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days | 3.08 score on a scale | Standard Deviation 3.37 |
| Usual Care (UC) | Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days | 1.64 score on a scale | Standard Deviation 3.11 |
p-value: 0.0218t-test, 2 sided
Secondary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days | 1.08 score on a scale | Standard Deviation 2.08 |
| Usual Care (UC) | Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days | 0.82 score on a scale | Standard Deviation 1.69 |
p-value: 0.509t-test, 2 sided
Secondary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days | 0.99 score on a scale | Standard Deviation 1.99 |
| Usual Care (UC) | Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days | 1.06 score on a scale | Standard Deviation 1.89 |
p-value: 0.8635t-test, 2 sided
Secondary
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.
Time frame: 180 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days | 1.89 score on a scale | Standard Deviation 3.41 |
| Usual Care (UC) | Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days | 1.33 score on a scale | Standard Deviation 3.13 |
p-value: 0.4034t-test, 2 sided
Secondary
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.
Time frame: 90 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD-CA | Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days | 1.77 score on a scale | Standard Deviation 3.41 |
| Usual Care (UC) | Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days | 0.47 score on a scale | Standard Deviation 3.45 |
p-value: 0.0471t-test, 2 sided