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| ID | Type | Description | Link |
|---|---|---|---|
| T32DK063688-13S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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To test a text messaging intervention using MyDiaText and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old. The intervention will consist of daily text messages sent to the subject's personal mobile device. Subjects will be incentivized to respond to text messages via a lottery financial incentive. Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention. |
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| Control | No Intervention | This group will receive the usual standard of care for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyDiaText | Other | The intervention will consist of daily text messages sent to the subject's personal mobile device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months | Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months | Hemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1="never do it" to 5 ="always do this as recommended, without fail"). Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terri Lipman, PhD | CHOP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention. MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device. |
| FG001 | Control | This group will receive the usual standard of care for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention. MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months | Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score. | Those analyzed were those who completed at least 1 self-care inventory survey. Analysis was preformed using multilevel mixed effects linear regression model. Outcomes are model-predicted. | Posted | Mean | Standard Error | score on a scale | 6 months |
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6 months
All-Cause Mortality and Serious Adverse Events were not monitored/assessed due to the very minimal risk of this text messaging intervention. Participants were counseled during the consent/assent process that they were eligible for the study if they had an unlimited text messaging plan, but that if that plan were to change they may begin to get charged for text messages. We asked that they reach out to us if their plan changed to avoid this event. No subjects reported this minor adverse event.
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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 | Intervention | This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention. MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara Kaushal, MD | Children's Hospital of Philadelphia | 6177322603 | tara.kaushal@joslin.harvard.edu |
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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 | Apr 22, 2019 | Aug 6, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2018 | Apr 28, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 6 months |
| BG001 | Control | This group will receive the usual standard of care for 6 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Control | This group will receive the usual standard of care for 6 months. |
|
|
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| Secondary | Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months | Hemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1="never do it" to 5 ="always do this as recommended, without fail"). Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control. | Not Posted | 6 months | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 83 |
| EG001 | Control | This group will receive the usual standard of care for 6 months. | 0 | 0 | 0 | 0 | 0 | 82 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |