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Study terminated prematurely due to operational futility.
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| Name | Class |
|---|---|
| Sutter Health | OTHER |
| Palo Alto Medical Foundation | OTHER |
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The goal of this study is to evaluate a digital chronic disease self-management program designed to provide virtual support and guidance for patients with type 2 diabetes.
Approximately 45% of patients with type 2 diabetes do not achieve adequate glycemic control (A1C < 7%). When diabetes is uncontrolled, complications develop that threaten health and endanger life. This study will make an effort to address this growing health challenge and to reduce the burden of diabetes in this population. More broadly, this study will have important implications and benefits for the growing diabetes population in the U.S. Study results will inform future interventions to reduce diabetes and improve outcomes. A better understanding of the efficacy of a digital chronic disease self-management program will directly benefit the participants of the program but, in the future, has the potential to more broadly benefit this population throughout the nation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Diabetes Self-Management Education and Support (DSMES) Program | Experimental | Participants will receive access to a 6-month online DSMES program that includes several components that are standard to DSMES. Participants receive online curriculum, access to a live Certified Diabetes Care and Education Specialist (CDCES), interactive group message forums, and connected devices for monitoring food intake, weight, physical activity and glucose levels. |
|
| Matched Control | No Intervention | A de-identified dataset of control subjects matched on baseline demographics and clinical characteristics will be cultivated for comparison to the active intervention arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Diabetes Self-Management Education and Support (DSMES) Program | Behavioral | Digital delivery of a DSMES program designed to build self-management skills and support diabetes management. Recipients have access to online curriculum, a live CDCES, group-based communication forums, and connected technology to track weight, food intake, physical activity and glucose levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c at 6 months from baseline | Non-fasting venous blood sample | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight at 6 months from baseline | Percentage of body weight loss | Baseline, 6 months |
| Change in medication adherence at 6 months from baseline | The Adherence Estimator, a three-item self-report questionnaire, will be used to assess medication adherence |
| Measure | Description | Time Frame |
|---|---|---|
| Health care utilization at 6 and 12 months from baseline | Patient electronic health record data will be collected to examine the impact on short-term health care utilization | Baseline, 6 months, 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang Li, PhD | Palo Alto Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation Research Institute | Palo Alto | California | 94301 | 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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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Baseline, 6 months |
| D004700 | Endocrine System Diseases |