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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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The study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California.
After designing the AYUDA program with input from the people it is meant to help, we are conducting a randomized pilot study. This study will test the program with younger Latinx adults who have recently been diagnosed with type 2 diabetes and who are also caregivers for dependent children.
AYUDA is a health system specifically designed for this group, focusing on their life stage as young adults and their cultural background. The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AYUDA Program | Experimental | Participants enrolled in the AYUDA program will receive text messages twice a week containing education and resources related to diabetes care and self-management, in addition to their usual diabetes care. |
|
| Usual Care | No Intervention | No intervention will be employed. This arm will continue to receive their usual diabetes care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AYUDA Program | Behavioral | Participants randomized to the intervention arm will be enrolled in the AYUDA program, where they will receive text messages twice a week over 12 weeks containing diabetes education and self-management resources, including links to resources available to all KPNC members. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between study arms in HbA1c change 6-months following enrollment | Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change. | 6-months following enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare contact | Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators. | 6-months following enrollment |
| Completion of recommended HbA1c monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Pleasanton | California | 94588 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Completing HbA1c labs
| 6-months following enrollment |
| T2D-related medication initiation | Initiation of T2D-related medication | 6-months following enrollment |
| T2D-related medication adherence | Adherence to T2D-related medication | 6-months following enrollment |
| Use of remote glucose monitoring to measure glucose levels | Use of a remote glucose monitoring to measure glucose levels | 6-months following enrollment |
| Participant-reported measures: Diabetes distress | Assessed at study enrollment and 6-months following enrollment | Study enrollment and 6-months following enrollment |
| Participant-reported measures: Motivation and locus of control | Assessed at study enrollment and 6-months following enrollment | Study enrollment and 6-months following enrollment |
| Participant-reported measures: Care Experience | Assessed at study enrollment and 6-months following enrollment | Study enrollment and 6-months following enrollment |
| Participant-reported measures: Children's Behaviors | Assessed at study enrollment and 6-months following enrollment | Study enrollment and 6-months following enrollment |
| D004700 | Endocrine System Diseases |