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The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.
This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Self-Management Behaviors | Experimental | Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks. |
|
| Usual Type 2 Diabetes Care | No Intervention | The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Self-Management Behaviors | Behavioral | The intervention is to be delivered by an interventionist. |
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| Measure | Description | Time Frame |
|---|---|---|
| Summary of Diabetes of Self-Care Activities Scale (11- item) | Change in diabetes self-management behaviors (0-7, higher scores indicate improvement) | (T0) baseline through (T3) 90 days post-intervention |
| Stanford Diabetes Self-Efficacy Scale (8- item) | Change in general self-efficacy 1-10, higher scores indicate improvement) | (T0) baseline through (T3) 90 days post-intervention |
| Wrist-worn actigraphy (ActiGraph) to be worn while awake | Change in physical activity (Frequent physical activity indicates improvement) | (T0) baseline through (T3) 90 days post-intervention |
| Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro | Time in range and glucose variability (More time in range and less glucose variability indicates improvement) | (T0) baseline through (T3) 90 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6 | Change in diabetes distress ( 0-6, lower scores indicates improvement) | (T0) baseline through (T3) 90 days post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cherlie Magny-Normilus, PhD, FNP-BC, FAAN | New York University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34610761 | Background | Magny-Normilus C, Whittemore R, Wexler DJ, Schnipper JL, Nunez-Smith M, Fu MR. Barriers to Type 2 Diabetes Management Among Older Adult Haitian Immigrants. Sci Diabetes Self Manag Care. 2021 Oct;47(5):382-390. doi: 10.1177/26350106211040435. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010358 | Patient Participation |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Behavioral: Diabetes Self-management behaviors
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Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |