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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18DK098742-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| New York City Department of Health and Mental Hygiene | OTHER_GOV |
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The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephonic Diabetes Self-Management Support | Experimental | This group receives all the Educational Print Materials received by the comparison condition plus telephone calls from a health educator to provide tailored diabetes self-management training and support. Participants with significant emotional distress at baseline also receive additional calls focused on distress management. |
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| Educational Print Materials | Active Comparator | Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephonic Diabetes Self-Management Support | Behavioral |
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| Educational Print Materials |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Obtained from electronic medical record. | Change from baseline at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Self-Management | Measured by self-report questionnaire | Change from baseline at 12 months |
| Medication Adherence | Measured by self-report questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S Gonzalez, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Winfred Y Wu, MD, MPH | New York City Department of Health and Mental Hygiene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York City Department of Health and Mental Hygiene | New York | New York | 11101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33022367 | Derived | Gonzalez JS, Hoogendoorn CJ, Linnell J, Fishman S, Jonas V, Pham-Singer H, Schechter CB, Walker EA, Wu WY. Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support. Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Other |
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| Change from baseline at 12 months |
| Diabetes-related distress | Measured by self-report questionnaire | Change from baseline at 12 months |
| Depressive symptoms | Measured by self-report questionnaire | Change from baseline at 12 months |
| Blood pressure | Obtained from electronic medical record. | Baseline and 12 months |
| Cholesterol | Obtained from electronic medical record. | Baseline and 12 months |
| D015438 | Health Behavior |
| D001519 | Behavior |