Diabetes Mellitus, Type 2, Patient Education, Patient Engagement
Conditions
Keywords
Immigrant Health, Diabetes Mellitus, Type 2, Metabolic Diseases, Self-Management Behaviors, Haitian Americans
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALDiabetes Self-Management Behaviors
The intervention is to be delivered by an interventionist.
Sponsors
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination
Intervention model description
Behavioral: Diabetes Self-management behaviors
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Self-described Haitian immigrant aged 21 and older * Known diagnosis of type 2 diabetes for at least one year * Have lived in the US for at least one year * Have an HbA1c of 7.5% * Willing and able to participate in an individual interview
Exclusion criteria
* Having a diagnosis of type 1 diabetes * Unable to comprehend, consent and or fully participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Diabetes of Self-Care Activities Scale (11- item) | (T0) baseline through (T3) 90 days post-intervention | Change in diabetes self-management behaviors (0-7, higher scores indicate improvement) |
| Stanford Diabetes Self-Efficacy Scale (8- item) | (T0) baseline through (T3) 90 days post-intervention | Change in general self-efficacy 1-10, higher scores indicate improvement) |
| Wrist-worn actigraphy (ActiGraph) to be worn while awake | (T0) baseline through (T3) 90 days post-intervention | Change in physical activity (Frequent physical activity indicates improvement) |
| Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro | (T0) baseline through (T3) 90 days post-intervention | Time in range and glucose variability (More time in range and less glucose variability indicates improvement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6 | (T0) baseline through (T3) 90 days post-intervention | Change in diabetes distress ( 0-6, lower scores indicates improvement) |
Countries
United States
Outcome results
None listed