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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01DK140613-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will adapt a community health worker (CHW)-led Type 2 diabetes (T2D) intervention to include mental health and digital components using a trauma informed care approach, and test the feasibility and acceptability of this intervention to support South Asians with T2D at risk for depression.
Specific Aim 1: Examine factors associated with distress, poor mental health, and comorbid T2D and depression among South Asians to inform pilot study structure and content.
Specific Aim 2: Adapt CHW-led T2D intervention to include mental health and digital components using a trauma-informed care approach and the ecological validity model.
Specific Aim 3: Evaluate the feasibility and acceptability of a pilot CHW-led intervention to support participants with T2D who are at risk for depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult South Asian patients in the New York City (NYC) region | Experimental | In Aim 3, CHWs will provide culturally and linguistically tailored health education to South Asian participants on the management of T2D and depressive symptoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHW-led T2D Intervention | Behavioral | CHW-led T2D intervention that includes mental health and digital health components. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Levels | Change in glycated hemoglobin (HbA1c). | Baseline, Month 3 |
| Change in Diabetes Distress Scale (DDS) Score | The Diabetes Distress Scale (DDS) is a 17-item psychological questionnaire designed to assess the emotional and psychological distress experienced by individuals with diabetes. Each item is rated on a scale of 0 to 6. The total score is calculated by summing up the scores of all 17 items and ranges from 0-102; higher scores indicate greater distress. | Baseline, Month 3 |
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | The PHQ-9 is a 9-item questionnaire to assess depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. Higher scores indicate greater severity of depression. | Baseline, Month 3 |
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Inclusion Criteria:
Aim 1 (Qualitative Component):
Aim 3: Pilot Intervention:
Exclusion Criteria:
Aim 1 (Qualitative Component):
• Diagnosed cognitive deficits or limited decision-making capacity
Aim 3: Pilot Intervention:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naheed Ahmed, PhD | Contact | 646-501-3751 | Naheed.Ahmed@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Naheed Ahmed, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
All of the individual participant data collected during the trial, after deidentification, will be shared with researchers who provide a methodologically sound proposals, provided the requesting researcher executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Study data will be deposited into the repository at the time of an associated study publication or end of performance period, whichever comes first. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study data will be deposited into the repository at the time of an associated study publication or end of performance period, whichever comes first.
Data are available for 5 years at a third party website (Link to be included).
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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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| D004700 | Endocrine System Diseases |