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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| San Diego State University | OTHER |
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This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile health) intervention that is tailored to individuals' needs and behavioral progress, in improving diabetes clinical control, adherence, and patient-provider communication in Hispanics - an at-risk, understudied population that experiences disparities in diabetes prevalence and outcomes. These striking disparities in the growing and aging US Hispanic population have taxed the US healthcare system, while significantly reducing quantity and quality of life for millions of individuals. By offering an innovative, scalable, and sustainable approach that seamlessly integrates several mHealth technologies into existing primary care team processes to improve the health of Hispanics (and eventually, other at-risk, underserved groups), DD-Me has strong potential to significantly impact public health.
Individuals of low socioeconomic (SES) and ethnic minority status, including Hispanics, the largest U.S. ethnic minority group, are disproportionately affected by diabetes. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, thus placing Hispanics at high risk for costly diabetes complications. The investigators' established academic-healthcare-community partnership has unique experience in developing and testing innovative, cost-effective, and sustainable chronic care interventions to reduce disparities and improve health in underserved communities. The investigators recently developed Dulce Digital (i.e., "one-size-fits-all" educational text messages, with nurse monitoring of patient-transmitted blood glucose values), which improved glycemic control across 6 months, relative to usual care in a recent randomized controlled trial (RCT) of N=126 Hispanic patients with poorly controlled type 2 diabetes (T2DM). The process evaluation for this trial indicated that Dulce Digital was both feasible and acceptable from patient and provider perspectives; however, patients expressed a preference for a more individualized intervention, and providers requested an even greater focus on health behavior change. Thus, the proposed RCT will examine the comparative effectiveness of Dulce Digital versus "Dulce Digital-Me" (DD-Me) in N=414 Hispanic adults of low SES with poorly controlled T2DM from Neighborhood Healthcare, a San Diego Federally-Qualified Health Center. Guided by patient and provider feedback, DD-Me includes Dulce Digital components plus personalized goal-setting and feedback that is responsive to the individual's needs and preferences. The DD-Me adaptive feedback component will be informed by the Resources and Support for Self-Management Model and Operant Conditioning Theory, and based on the individual's progress on intermediate behavioral targets (i.e., medication adherence assessed by wireless sensor; brief mobile phone-based assessments of diet, physical activity, stress). Feedback will be delivered via algorithm-driven automated messaging in 50% of DD-Me participants and by the care team medical assistant in the remaining half to determine the feasibility and acceptability (given the purported cultural relevance of interpersonal relationships in the Hispanic culture), and the comparative effectiveness and cost of each delivery method. Changes in indicators of diabetes clinical control [i.e., glycosylated hemoglobin (HbA1c) low density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP)], patient-provider communication, and patient adherence (i.e., to medication and other diabetes self-management behaviors) will be evaluated across twelve months. Thorough process and cost-effectiveness analyses will evaluate the scalability and sustainability potential of DD-Me. This comparative evaluation of two mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within existing nurse-led chronic care approaches to meet the complex needs of underserved individuals with poorly controlled T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dulce Digital | Experimental | The first of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives one-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. |
|
| Dulce Digital-Me (Automated Delivery) | Experimental | The second of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. |
|
| Dulce Digital-Me (Medical Assistant) | Experimental | The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulce Digital | Behavioral | One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment | Glycosylated Hemoglobin (HbA1c) six months after enrollment | 6 months from baseline |
| Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment | Glycosylated Hemoglobin (HbA1c) twelve months after enrollment | 12 months from baseline |
| Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment | Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment | 6 months from baseline |
| Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment | Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment | 12 months from baseline |
| Systolic Blood Pressure (SBP); 6 Months From Enrollment | Systolic blood pressure (SBP); six months from enrollment | 6 months from baseline |
| Systolic Blood Pressure (SBP); 12 Months From Enrollment | Systolic blood pressure (SBP); twelve months from enrollment | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Provider Communication; 6 Months From Enrollment | Patient-Provider Communication as reported by patient; six months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome. | 6 months from baseline |
| Patient-Provider Communication; 12 Months From Enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athena Philis-Tsimikas, MD | Scripps Whittier Diabetes Institute | Principal Investigator |
| Linda Gallo, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Mercy Chula Vista | Chula Vista | California | 91910 | United States | ||
| Scripps Whittier Diabetes Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39707158 | Derived | Philis-Tsimikas A, Fortmann AL, Clark T, Spierling Bagsic SR, Farcas E, Roesch SC, Schultz J, Gilmer TP, Godino JG, Savin KL, Chichmarenko M, Jones JA, Sandoval H, Gallo LC. Dulce Digital-Me: results of a randomized comparative trial of static versus adaptive digital interventions for Latine adults with diabetes. Ann Behav Med. 2025 Jan 4;59(1):kaae077. doi: 10.1093/abm/kaae077. | |
| 35090520 | Derived | Philis-Tsimikas A, Fortmann AL, Godino JG, Schultz J, Roesch SC, Gilmer TP, Farcas E, Sandoval H, Savin KL, Clark T, Chichmarenko M, Jones JA, Gallo LC. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Trials. 2022 Jan 28;23(1):80. doi: 10.1186/s13063-021-05899-x. |
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The target sample size based on power analysis was N=414. Enrollment started October 31, 2017 was paused on March 13, 2020, and then concluded early due to the COVID-19 pandemic. Because the design accommodated at 30% attrition rate, sample size was adequate for analysis of outcomes.
Between October 2017 and March 2020, the study enrolled 310 Hispanic adults with low income and poorly managed type 2 diabetes from a San Diego County Federally Qualified Health Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dulce Digital | The first of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives one-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. Dulce Digital: One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. |
| FG001 | Dulce Digital-Me (Automated Delivery) | The second of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. Dulce Digital-Me (Automated Delivery): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. |
| FG002 | Dulce Digital-Me (Medical Assistant) | The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. Dulce Digital-Me (Medical Assistant): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Hispanic adults with low income and poorly managed type 2 diabetes are enrolled from a San Diego County Federally Qualified Health Center.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dulce Digital | The first of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives one-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. Dulce Digital: One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment | Glycosylated Hemoglobin (HbA1c) six months after enrollment | Participants that came in for 6-month measures | Posted | Mean | Standard Deviation | percentage | 6 months from baseline |
|
From the time of individual patient recruitment at baseline through the end of month 12.
The one all-cause mortality event was discovered when attempting to reach a participant to complete the 12-month measures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dulce Digital | The first of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives one-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. Dulce Digital: One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Athena Philis-Tsimikas, MD, Co-Principal Investigator | Scripps Health | 858-678-7045 | philis-tsimikas.athena@scrippshealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2017 | Mar 7, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 5, 2020 | Mar 7, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Dulce Digital-Me (Automated Delivery) | Behavioral | Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. |
|
| Dulce Digital-Me (Medical Assistant) | Behavioral | Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. |
|
Patient-Provider Communication as reported by patient; twelve months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome. |
| 12 months from baseline |
| Patient Blood Glucose Monitoring; 6 Months From Enrollment | Patient Blood Glucose Monitoring as reported by patient; six months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome. | 6 months from baseline |
| Patient Blood Glucose Monitoring; 12 Months From Enrollment | Patient Blood Glucose Monitoring as reported by patient; twelve months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome. | 12 months from baseline |
| Participated in Aerobic Exercise; 6 Months From Enrollment | Participated in Aerobic Exercise as reported by patient, six months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome. | 6 months from baseline |
| Participated in Aerobic Exercise; 12 Months From Enrollment | Participated in Aerobic Exercise as reported by patient, twelve months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome. | 12 months from baseline |
| Participated in Strength Exercise; 6 Months From Enrollment | Participated in Strength Exercise as reported by patient; six months from enrollment | 6 months from baseline |
| Participated in Strength Exercise; 12 Months From Enrollment | Participated in Strength Exercise as reported by patient; twelve months from enrollment | 12 months from baseline |
| Participated in Flexibility Exercise; 6 Months From Enrollment | Participated in Flexibility Exercise as reported by patient; six months from enrollment | 6 months from baseline |
| Participated in Flexibility Exercise; 12 Months From Enrollment | Participated in Flexibility Exercise as reported by patient; twelve months from enrollment | 12 months from baseline |
| Healthy Eating Behaviors; 6 Months From Enrollment | Healthy Eating Behaviors as reported by patient; six months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome. | 6 months from baseline |
| Healthy Eating Behaviors; 12 Months From Enrollment | Healthy Eating Behaviors as reported by patient; twelve months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome. | 12 months from baseline |
| Diabetes Distress; 6 Months From Enrollment | Diabetes Distress as reported by patient; six months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome. | 6 months from baseline |
| Diabetes Distress; 12 Months From Enrollment | Diabetes Distress as reported by patient; twelve months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome. | 12 months from baseline |
| Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; six months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome. | 6 months from baseline |
| Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; twelve months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome. | 12 months from baseline |
| La Jolla |
| California |
| 92037 |
| United States |
| Withdrawal by PI |
|
| Death |
|
| BG001 | Dulce Digital-Me (Automated Delivery) | The second of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. Dulce Digital-Me (Automated Delivery): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. |
| BG002 | Dulce Digital-Me (Medical Assistant) | The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. Dulce Digital-Me (Medical Assistant): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Less than High School Education/GED | Count of Participants | Participants |
|
| Yearly household income | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Married or Living with Partner | Count of Participants | Participants |
|
| Place of Birth | Count of Participants | Participants |
|
| Primary Language is Spanish | Count of Participants | Participants |
|
| Has Some Type of Health Insurance | Count of Participants | Participants |
|
| Health Literacy | Single Item Literacy Scale | Count of Participants | Participants |
|
| Duration of Diabetes Diagnosis | Mean | Standard Deviation | years |
|
| BMI | Mean | Standard Deviation | units kg/m^2 |
|
| Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin |
|
| Low-density Lipoprotein-cholesterol (LDL-C); | Sample sizes differ due to missing values. | Mean | Standard Deviation | mg/dL |
|
| Systolic Blood Pressure (SBP) | Sample sizes differ due to missing values. | Mean | Standard Deviation | mm/Hg |
|
| Patient-Provider Communication | Patient- provider communication was assessed using the healthcare team subscale of the Chronic Illness Resource Survey (range, 1-5). Higher scores indicate greater perceived support or engagement with the healthcare team (e.g., physicians, nurses, diabetes educators) in managing the chronic illness. | Sample sizes differ due to missing values. | Mean | Standard Deviation | units on a scale |
|
| Patient Blood Glucose Monitoring | Sample sizes differ due to missing values. | Mean | Standard Deviation | days per week |
|
| Participated in Aerobic Exercise | Aerobic exercise was assessed using the aerobic subscale of the Rapid Assessment of Physical Activity (Seven-point scale, 1-7). | Sample sizes differ due to missing values. | Mean | Standard Deviation | units on a scale |
|
| Participated in Strength Exercise | Count of Participants | Participants |
|
| Participated in Flexibility Exercise | Count of Participants | Participants |
|
| Healthy Eating Behaviors | Mean | Standard Deviation | units on a scale |
|
| Diabetes Distress | Sample sizes differ due to missing values. | Mean | Standard Deviation | units on a scale |
|
| Adherence to Refills and Medications Scale (ARMS) | Sample sizes differ due to missing values. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Dulce Digital-Me (Medical Assistants) | The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. |
| OG003 | Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants) |
|
|
|
| Primary | Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment | Glycosylated Hemoglobin (HbA1c) twelve months after enrollment | Participants that came in for 12-month measures | Posted | Mean | Standard Deviation | percentage | 12 months from baseline |
|
|
|
|
| Primary | Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment | Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment | Participants | Posted | Mean | Standard Deviation | mg/dL | 6 months from baseline |
|
|
|
|
| Primary | Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment | Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment | Participants | Posted | Mean | Standard Deviation | mg/dL | 12 months from baseline |
|
|
|
|
| Primary | Systolic Blood Pressure (SBP); 6 Months From Enrollment | Systolic blood pressure (SBP); six months from enrollment | Participants | Posted | Mean | Standard Deviation | mm/Hg | 6 months from baseline |
|
|
|
|
| Primary | Systolic Blood Pressure (SBP); 12 Months From Enrollment | Systolic blood pressure (SBP); twelve months from enrollment | Participants | Posted | Mean | Standard Deviation | mm/Hg | 12 months from baseline |
|
|
|
|
| Secondary | Patient-Provider Communication; 6 Months From Enrollment | Patient-Provider Communication as reported by patient; six months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 6 months from baseline |
|
|
|
|
| Secondary | Patient-Provider Communication; 12 Months From Enrollment | Patient-Provider Communication as reported by patient; twelve months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 12 months from baseline |
|
|
|
|
| Secondary | Patient Blood Glucose Monitoring; 6 Months From Enrollment | Patient Blood Glucose Monitoring as reported by patient; six months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome. | Participants | Posted | Mean | Standard Deviation | days per week | 6 months from baseline |
|
|
|
|
| Secondary | Patient Blood Glucose Monitoring; 12 Months From Enrollment | Patient Blood Glucose Monitoring as reported by patient; twelve months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome. | Participants | Posted | Mean | Standard Deviation | days per week | 12 months from baseline |
|
|
|
|
| Secondary | Participated in Aerobic Exercise; 6 Months From Enrollment | Participated in Aerobic Exercise as reported by patient, six months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 6 months from baseline |
|
|
|
|
| Secondary | Participated in Aerobic Exercise; 12 Months From Enrollment | Participated in Aerobic Exercise as reported by patient, twelve months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 12 months from baseline |
|
|
|
|
| Secondary | Participated in Strength Exercise; 6 Months From Enrollment | Participated in Strength Exercise as reported by patient; six months from enrollment | Participants | Posted | Count of Participants | Participants | 6 months from baseline |
|
|
|
|
| Secondary | Participated in Strength Exercise; 12 Months From Enrollment | Participated in Strength Exercise as reported by patient; twelve months from enrollment | Participants | Posted | Count of Participants | Participants | 12 months from baseline |
|
|
|
|
| Secondary | Participated in Flexibility Exercise; 6 Months From Enrollment | Participated in Flexibility Exercise as reported by patient; six months from enrollment | Participants | Posted | Count of Participants | Participants | 6 months from baseline |
|
|
|
|
| Secondary | Participated in Flexibility Exercise; 12 Months From Enrollment | Participated in Flexibility Exercise as reported by patient; twelve months from enrollment | Participants | Posted | Count of Participants | Participants | 12 months from baseline |
|
|
|
|
| Secondary | Healthy Eating Behaviors; 6 Months From Enrollment | Healthy Eating Behaviors as reported by patient; six months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 6 months from baseline |
|
|
|
|
| Secondary | Healthy Eating Behaviors; 12 Months From Enrollment | Healthy Eating Behaviors as reported by patient; twelve months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 12 months from baseline |
|
|
|
|
| Secondary | Diabetes Distress; 6 Months From Enrollment | Diabetes Distress as reported by patient; six months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 6 months from baseline |
|
|
|
|
| Secondary | Diabetes Distress; 12 Months From Enrollment | Diabetes Distress as reported by patient; twelve months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 12 months from baseline |
|
|
|
|
| Secondary | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; six months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 6 months from baseline |
|
|
|
|
| Secondary | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; twelve months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome. | Participants | Posted | Mean | Standard Deviation | score on a scale | 12 months from baseline |
|
|
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| 0 |
| 107 |
| EG001 | Dulce Digital-Me (Automated Delivery) | The second of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. Dulce Digital-Me (Automated Delivery): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. | 0 | 106 | 0 | 106 | 0 | 106 |
| EG002 | Dulce Digital-Me (Medical Assistant) | The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. Dulce Digital-Me (Medical Assistant): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. | 1 | 97 | 0 | 97 | 0 | 97 |
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| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| $20,000 to $30,000 |
|
| Greater than $30,000 |
|
| Unknown or Not Reported |
|
| Employed Part Time |
|
| Employed Full Time |
|
| Unknown or Not Reported |
|
| Mexico |
|
| Other |
|
| Limited |
|