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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK046887 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Charles H. Hood Foundation | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention |
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| Care Plus | Experimental |
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| Care Ultra | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Ambassador Intervention | Behavioral | Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control, assessed by hemoglobin A1c | Every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors) | Annually | |
| Weight, assessed by z-BMI (age- and gender-adjusted body mass index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Laffel, MD, MPH | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18774997 | Background | Butler DA, Zuehlke JB, Tovar A, Volkening LK, Anderson BJ, Laffel LM. The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):373-81. doi: 10.1111/j.1399-5448.2008.00370.x. | |
| 17307546 | Background | Svoren BM, Volkening LK, Butler DA, Moreland EC, Anderson BJ, Laffel LM. Temporal trends in the treatment of pediatric type 1 diabetes and impact on acute outcomes. J Pediatr. 2007 Mar;150(3):279-85. doi: 10.1016/j.jpeds.2006.12.009. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Psychoeducational Intervention | Behavioral | A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout". |
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| Every 3 months |
| Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia | Every 3 months |
| 15570991 | Background | Moreland EC, Tovar A, Zuehlke JB, Butler DA, Milaszewski K, Laffel LM. The impact of physiological, therapeutic and psychosocial variables on glycemic control in youth with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2004 Nov;17(11):1533-44. doi: 10.1515/jpem.2004.17.11.1533. |
| 23914987 | Result | Katz ML, Volkening LK, Butler DA, Anderson BJ, Laffel LM. Family-based psychoeducation and Care Ambassador intervention to improve glycemic control in youth with type 1 diabetes: a randomized trial. Pediatr Diabetes. 2014 Mar;15(2):142-50. doi: 10.1111/pedi.12065. Epub 2013 Aug 5. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |